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Our primary aim is to determine the most beneficial suture in order to reduce complications due to skin incision in common surgeries such as cesarean section, and our secondary aim is to evaluate the suture material used in terms of cosmetic results and participant preference.
Patients who met the inclusion criteria among patients who had a cesarean delivery (January 2023-June 2023) in our hospital within a 6-month period will be included in the study. Patients included in the study will be randomized and divided into three randomized groups as Vicryl (Polyglactin 910), Monocryl (Polyglecaprone 25) and Prolene (polypropylene) to be administered. Each cesarean section technique will be left to the discretion of the surgeon performing the operation, and cefazolin 2 g will be administered prophylactically half an hour before each procedure in our clinic. In all cases, a Pfannenstiel skin incision will be made 2 cm above the pubic symphysis. Following delivery of the fetus, the uterus, peritoneum, and fascia will be closed in sequence. The skin will be sealed with Vicryl (Polyglactin 910), Monocryl (Polyglecaprone 25), and Prolene (polypropylene) according to randomization. The dressing will be removed on the first day after the operation and the patients will be discharged on the second post-op day if there is no problem after the operation. Patients will be called for control on the 10th , 60th and 120th days of pos op. If the post op 10th day is deemed appropriate, the sutures of the patients in the prolene suture group will be removed. All groups that come to the control will be evaluated with the patient and the observer doctor by the patient and observer rating scale (POSAS) and the Vancouver Scar Scale (VSS).
The Patient and Observer Rating Scale (POSAS) is a questionnaire developed to assess scar quality. It consists of a five-observer and six-patient scale (Observer and Patient Scales) according to the rating scale based on clinically relevant scar characteristics [ Draaijers LJ, 2004 , Van de Kar AL, 2005]. Observer ; scores six items: vascularization, pigmentation, thickness, surface roughness, flexibility, and surface area. Patient ; it scores six items: pain, itching, color, thickness, relief and flexibility [Van de Kar AL , 2005]. All included items are scored on a multiple 10-point scale where 1 point is given when the wound feature is similar to 'normal skin' and 10 points are awarded when it reflects the 'worst scar'. All items are summed to determine the total scar score, with a higher score representing worse scar quality.
The Vancouver scar scale (VSS) consists of four variables: vascularity, height (thickness), elasticity, and pigmentation. The total score ranges from 0 to 14, with a score of 0 reflecting normal skin
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (Vicryl suture™(Polyglactin 910)) | Active Comparator | The group whose skin incision was closed with Vicryl suture™ (Polyglactin 910) from patients who had cesarean section for the first time |
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| Group 2 (Prolene suture™(polypropylene)) | Active Comparator | The group whose skin incision was closed with Prolene suture™ (polypropylene) from patients who had cesarean section for the first time |
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| Group 3 (Monocryl suture™ (Polyglecaprone 25)) | Active Comparator | The group whose skin incision was closed with Tekmon suture™ (Polyglecaprone 25) from patients who had cesarean section for the first time |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evaluation of the wound infection at the 10th day post-op check-up among all groups | Other | Discharge, redness, increased temperature, and dehiscence were accepted as wound infection. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the Difference Between the Groups in the Number of Patients With Wound Infection at the End of the 10th Postoperative Day | At the 10th postoperative day follow-up, discharge, redness, increased temperature and wound opening were considered as wound infection. | 0-10. day |
| Comparison of Incision Cosmetic Results Between Group 1 (Vicryl Suture™(Polyglactin 910)) and Group 2 (Prolene Suture™(Polypropylene)) at the End of the 2nd Postoperative Month and at the End of the 6th Postoperative Month by POSAS | The cosmetic outcome of wound healing was assessed using two different scales. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to assess wound quality. The investigator scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, elevation, and elasticity. All items are scored on a 10-point scale; 1 point is given when the wound characteristic is similar to 'normal skin', and 10 points are given when it reflects the 'worst wound'. The total score closest to normal skin is 11, and the total score reflecting the worst wound is 110. The other scale is the Vancouver Wound Scale (VSS), consisting of four variables: vascularity, height (thickness), elasticity, and pigmentation. The total score ranges from 0 to 13, with 0 reflecting normal skin and 13 reflecting the worst wound. | End of the 2nd month and 6th month |
| Comparison of Incision Cosmetic Results Between Group 1 (Vicryl Suture™(Polyglactin 910)) and Group 3 (Tekmon Suture™(Poliglekapron 25)) at the End of the 2nd Postoperative Month and at the End of the 6th Postoperative Month by POSAS | The cosmetic outcome of wound healing was assessed using two different scales. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to assess wound quality. The investigator scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, elevation, and elasticity. All items are scored on a 10-point scale; 1 point is given when the wound characteristic is similar to 'normal skin', and 10 points are given when it reflects the 'worst wound'. The total score closest to normal skin is 11, and the total score reflecting the worst wound is 110. The other scale is the Vancouver Wound Scale (VSS), consisting of four variables: vascularity, height (thickness), elasticity, and pigmentation. The total score ranges from 0 to 13, with 0 reflecting normal skin and 13 reflecting the worst wound. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ayşenur ÇALIŞ ÖZBAYRAM | yok | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Başakşehir Çam Ve Sakura Şehir Hastanesi | Istanbul | Başakşehir | 00034 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32228099 | Background | Koroglu N, Temel Yuksel I, Aslan Cetin B, Aytufan Z, Deniz N, Akca A, Yetkin Yildirim G, Yuksel A. Skin closure at cesarean section, polypropylene versus polyglactin 910: a randomized controlled study. J Matern Fetal Neonatal Med. 2022 Mar;35(6):1088-1092. doi: 10.1080/14767058.2020.1743654. Epub 2020 Mar 30. | |
| 20417924 | Background |
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Inclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 (Vicryl Suture™(Polyglactin 910)) | The group whose skin incision is closed with Vicryl suture™ (Polyglactin 910) Evaluation of wound infection at the 10th postoperative day control: Discharge, redness, temperature increase and opening were accepted as wound infection.Evaluation of the cosmetic results of the incision line in all groups at the 2nd and 6th month postoperative controls: The cosmetic results of wound healing are two different It was evaluated with a scale. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to evaluate scar quality. The researcher scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, relief, and flexibility. All items are scored on a 10-point multiple scale; 1 point is given when the scar characteristic resembles 'normal skin', and 10 points are given when it reflects the 'worst scar'. All items are summed to determine the total scar score; a higher score represents worse scar quality. The Vancouver scar scale (VSS) consists of four variables: vascularity, height (thickness), elasticity and pigmentation. The total score ranges from 0 to 14, with a score of 0 reflecting normal skin. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Feb 22, 2023 |
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| Evaluation of the cosmetic results of the incision line at the 2nd month post-op check-up among all groups | Other | The cosmetic outcome of wound site scar healing was evaluated with two different scales. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to assess scar quality. The investigator scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, relief, and flexibility. All items are scored on a 10-point multiple scale; A score of 1 is given when the scar characteristic is similar to 'normal skin' and a score of 10 is given when it reflects the 'worst scar'. All items are summed to determine the total scar score; a higher score represents worse scar quality. The Vancouver scar scale (VSS) consists of four variables: vascularity, height (thickness), elasticity and pigmentation. The total score ranges from 0 to 14, with a score of 0 reflecting normal skin. |
|
|
| Evaluation of the cosmetic results of the incision line at the 6th month post-op check-up among all groups | Other | The cosmetic outcome of wound site scar healing was evaluated with two different scales. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to assess scar quality. The investigator scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, relief, and flexibility. All items are scored on a 10-point multiple scale; A score of 1 is given when the scar characteristic is similar to 'normal skin' and a score of 10 is given when it reflects the 'worst scar'. All items are summed to determine the total scar score; a higher score represents worse scar quality. The Vancouver scar scale (VSS) consists of four variables: vascularity, height (thickness), elasticity and pigmentation. The total score ranges from 0 to 14, with a score of 0 reflecting normal skin. |
|
|
| End of the 2nd month and 6thmonth |
| Comparison of Incision Cosmetic Results Between Group 2 (Prolene Suture™(Polypropylene)) and Group 3 (Tekmon Suture™(Poliglekapron 25)) at the End of the 2nd Postoperative Month and at the End of the 6th Postoperative Month by POSAS | The cosmetic outcome of wound healing was assessed using two different scales. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to assess wound quality. The investigator scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, elevation, and elasticity. All items are scored on a 10-point scale; 1 point is given when the wound characteristic is similar to 'normal skin', and 10 points are given when it reflects the 'worst wound'. The total score closest to normal skin is 11, and the total score reflecting the worst wound is 110. The other scale is the Vancouver Wound Scale (VSS), consisting of four variables: vascularity, height (thickness), elasticity, and pigmentation. The total score ranges from 0 to 13, with 0 reflecting normal skin and 13 reflecting the worst wound. | End of the 2nd month and 6thmonth |
| Comparison of Incision Cosmetic Results Between Group 1(Vicryl Suture™(Polyglactin 910)) and Group 2(Prolene Suture™(Polypropylene)) at the End of the 2nd Postoperative Month and at the End of the 6th Postoperative Month by The Vancouver Scar Scale (VSS) | The cosmetic outcome of wound healing was assessed using two different scales. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to assess wound quality. The investigator scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, elevation, and elasticity. All items are scored on a 10-point scale; 1 point is given when the wound characteristic is similar to 'normal skin', and 10 points are given when it reflects the 'worst wound'. The total score closest to normal skin is 11, and the total score reflecting the worst wound is 110. The other scale is the Vancouver Wound Scale (VSS), consisting of four variables: vascularity, height (thickness), elasticity, and pigmentation. The total score ranges from 0 to 13, with 0 reflecting normal skin and 13 reflecting the worst wound. | End of the 2nd month and 6th month |
| Comparison of Incision Cosmetic Results Between Group 1(Vicryl Suture™(Polyglactin 910)) and Group 3(Tekmon Suture™(Poliglekapron 25)) at the End of the 2nd Postoperative Month and at the End of the 6th Postoperative Month by The Vancouver Scar Scale(VSS) | The cosmetic outcome of wound healing was assessed using two different scales. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to assess wound quality. The investigator scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, elevation, and elasticity. All items are scored on a 10-point scale; 1 point is given when the wound characteristic is similar to 'normal skin', and 10 points are given when it reflects the 'worst wound'. The total score closest to normal skin is 11, and the total score reflecting the worst wound is 110. The other scale is the Vancouver Wound Scale (VSS), consisting of four variables: vascularity, height (thickness), elasticity, and pigmentation. The total score ranges from 0 to 13, with 0 reflecting normal skin and 13 reflecting the worst wound. | End of the 2nd month and 6th month |
| Comparison of Incision Cosmetic Results Between Group 2(Prolene Suture™(Polypropylene)) and Group 3(Tekmon Suture™(Poliglekapron 25)) at the End of the 2nd Postoperative Month and at the End of the 6th Postoperative Month by The Vancouver Scar Scale(VSS) | The cosmetic outcome of wound healing was assessed using two different scales. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to assess wound quality. The investigator scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, elevation, and elasticity. All items are scored on a 10-point scale; 1 point is given when the wound characteristic is similar to 'normal skin', and 10 points are given when it reflects the 'worst wound'. The total score closest to normal skin is 11, and the total score reflecting the worst wound is 110. The other scale is the Vancouver Wound Scale (VSS), consisting of four variables: vascularity, height (thickness), elasticity, and pigmentation. The total score ranges from 0 to 13, with 0 reflecting normal skin and 13 reflecting the worst wound. | End of the 2nd month and 6th month |
| Cromi A, Ghezzi F, Gottardi A, Cherubino M, Uccella S, Valdatta L. Cosmetic outcomes of various skin closure methods following cesarean delivery: a randomized trial. Am J Obstet Gynecol. 2010 Jul;203(1):36.e1-8. doi: 10.1016/j.ajog.2010.02.001. Epub 2010 Apr 24. |
| 28796687 | Result | Buresch AM, Van Arsdale A, Ferzli M, Sahasrabudhe N, Sun M, Bernstein J, Bernstein PS, Ngai IM, Garry DJ. Comparison of Subcuticular Suture Type for Skin Closure After Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2017 Sep;130(3):521-526. doi: 10.1097/AOG.0000000000002200. |
| 30869751 | Result | Byrne M, Aly A. The Surgical Suture. Aesthet Surg J. 2019 Mar 14;39(Suppl_2):S67-S72. doi: 10.1093/asj/sjz036. |
| FG001 | Group 2 (Prolene Suture™(Polypropylene)) | The group whose skin incision is closed with Prolene suture™ (polypropylene) Evaluation of wound infection at the 10th postoperative day control: Discharge, redness, temperature increase and opening were accepted as wound infection. Evaluation of the cosmetic results of the incision line in all groups at the 2nd and 6th month postoperative controls: The cosmetic results of wound healing are two different It was evaluated with a scale. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to evaluate scar quality. The researcher scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, relief, and flexibility. All items are scored on a 10-point multiple scale; 1 point is given when the scar characteristic resembles 'normal skin', and 10 points are given when it reflects the 'worst scar'. All items are summed to determine the total scar score; a higher score represents worse scar quality. The Vancouver scar scale (VSS) consists of four variables: vascularity, height (thickness), elasticity and pigmentation. The total score ranges from 0 to 14, with a score of 0 reflecting normal skin. |
| FG002 | Group 3 (Monocryl Suture™ (Polyglecaprone 25)) | The group whose skin incision is closed with Tekmon suture™ (Polyglecaprone 25) Evaluation of wound infection at the 10th postoperative day control: Discharge, redness, temperature increase and opening were accepted as wound infection. Evaluation of the cosmetic results of the incision line in all groups at the 2nd and 6th month postoperative controls: The cosmetic results of wound healing are two different It was evaluated with a scale. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to evaluate scar quality. The researcher scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, relief, and flexibility. All items are scored on a 10-point multiple scale; 1 point is given when the scar characteristic resembles 'normal skin', and 10 points are given when it reflects the 'worst scar'. All items are summed to determine the total scar score; a higher score represents worse scar quality. The Vancouver scar scale (VSS) consists of four variables: vascularity, height (thickness), elasticity and pigmentation. The total score ranges from 0 to 14, with a score of 0 reflecting normal skin. |
| Post op 10th Day Check-up |
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| Post op 2nd Month Check-up |
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| Post op 6st Month Check-up |
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| COMPLETED |
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| NOT COMPLETED |
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18-45 years old Patients who underwent primary cesarean section in our hospital over 37 weeks of gestation Patients whose Pfannenstiel incision was closed subcutaneously
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 (Vicryl Suture™(Polyglactin 910)) | The group of patients who had a cesarean section for the first time and whose skin incision was closed with Vicryl suture™ (Polyglactin 910) Evaluation of wound infection at the 10th postoperative day control: Discharge, redness, increased temperature and opening were accepted as wound infection. Evaluation of the cosmetic results of the incision line in all groups at the 2nd and 6th month postoperative controls: The cosmetic results of wound healing are two different It was evaluated with a scale. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to evaluate scar quality. The researcher scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, relief, and flexibility. All items are scored on a 10-point multiple scale; 1 point is given when the scar characteristic resembles 'normal skin', and 10 points are given when it reflects the 'worst scar'. All items are summed to determine the total scar score; a higher score represents worse scar quality. The Vancouver scar scale (VSS) consists of four variables: vascularity, height (thickness), elasticity and pigmentation. The total score ranges from 0 to 14, with a score of 0 reflecting normal skin. |
| BG001 | Group 2 (Prolene Suture™(Polypropylene)) | The group of patients who had a cesarean section for the first time and whose skin incision was closed with Prolene suture™ (polypropylene) Evaluation of wound infection at the 10th postoperative day control: Discharge, redness, increased temperature and opening were accepted as wound infection. Evaluation of the cosmetic results of the incision line in all groups at the 2nd and 6th month postoperative controls: The cosmetic results of wound healing are two different It was evaluated with a scale. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to evaluate scar quality. The researcher scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, relief, and flexibility. All items are scored on a 10-point multiple scale; 1 point is given when the scar characteristic resembles 'normal skin', and 10 points are given when it reflects the 'worst scar'. All items are summed to determine the total scar score; a higher score represents worse scar quality. The Vancouver scar scale (VSS) consists of four variables: vascularity, height (thickness), elasticity and pigmentation. The total score ranges from 0 to 14, with a score of 0 reflecting normal skin. |
| BG002 | Group 3 (Monocryl Suture™ (Polyglecaprone 25)) | The group of patients who had a cesarean section for the first time and whose skin incision was closed with Tekmon suture™ (Polyglecaprone 25) Evaluation of wound infection at the 10th postoperative day control: Discharge, redness, increased temperature and opening were accepted as wound infection. Evaluation of the cosmetic results of the incision line in all groups at the 2nd and 6th month postoperative controls: The cosmetic results of wound healing are two different It was evaluated with a scale. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to evaluate scar quality. The researcher scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, relief, and flexibility. All items are scored on a 10-point multiple scale; 1 point is given when the scar characteristic resembles 'normal skin', and 10 points are given when it reflects the 'worst scar'. All items are summed to determine the total scar score; a higher score represents worse scar quality. The Vancouver scar scale (VSS) consists of four variables: vascularity, height (thickness), elasticity and pigmentation. The total score ranges from 0 to 14, with a score of 0 reflecting normal skin. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| BMI | Mean | Standard Deviation | kg/m² |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Evaluation of the Difference Between the Groups in the Number of Patients With Wound Infection at the End of the 10th Postoperative Day | At the 10th postoperative day follow-up, discharge, redness, increased temperature and wound opening were considered as wound infection. | Inclusion Criteria: 18-45 years old Patients who had a primary cesarean section at 37w Patients with a Pfannenstiel incision closed subcutaneously | Posted | Count of Participants | Participants | 0-10. day |
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| Primary | Comparison of Incision Cosmetic Results Between Group 1 (Vicryl Suture™(Polyglactin 910)) and Group 2 (Prolene Suture™(Polypropylene)) at the End of the 2nd Postoperative Month and at the End of the 6th Postoperative Month by POSAS | The cosmetic outcome of wound healing was assessed using two different scales. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to assess wound quality. The investigator scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, elevation, and elasticity. All items are scored on a 10-point scale; 1 point is given when the wound characteristic is similar to 'normal skin', and 10 points are given when it reflects the 'worst wound'. The total score closest to normal skin is 11, and the total score reflecting the worst wound is 110. The other scale is the Vancouver Wound Scale (VSS), consisting of four variables: vascularity, height (thickness), elasticity, and pigmentation. The total score ranges from 0 to 13, with 0 reflecting normal skin and 13 reflecting the worst wound. | Inclusion Criteria: 18-45 years old Patients who had a primary cesarean section at 37w Patients with a Pfannenstiel incision closed subcutaneously | Posted | Mean | Standard Deviation | units on a scale | End of the 2nd month and 6th month |
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| Primary | Comparison of Incision Cosmetic Results Between Group 1 (Vicryl Suture™(Polyglactin 910)) and Group 3 (Tekmon Suture™(Poliglekapron 25)) at the End of the 2nd Postoperative Month and at the End of the 6th Postoperative Month by POSAS | The cosmetic outcome of wound healing was assessed using two different scales. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to assess wound quality. The investigator scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, elevation, and elasticity. All items are scored on a 10-point scale; 1 point is given when the wound characteristic is similar to 'normal skin', and 10 points are given when it reflects the 'worst wound'. The total score closest to normal skin is 11, and the total score reflecting the worst wound is 110. The other scale is the Vancouver Wound Scale (VSS), consisting of four variables: vascularity, height (thickness), elasticity, and pigmentation. The total score ranges from 0 to 13, with 0 reflecting normal skin and 13 reflecting the worst wound. | Inclusion Criteria: 18-45 years old Patients who had a primary cesarean section at 37w Patients with a Pfannenstiel incision closed subcutaneously | Posted | Mean | Standard Deviation | units on a scale | End of the 2nd month and 6thmonth |
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| Primary | Comparison of Incision Cosmetic Results Between Group 2 (Prolene Suture™(Polypropylene)) and Group 3 (Tekmon Suture™(Poliglekapron 25)) at the End of the 2nd Postoperative Month and at the End of the 6th Postoperative Month by POSAS | The cosmetic outcome of wound healing was assessed using two different scales. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to assess wound quality. The investigator scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, elevation, and elasticity. All items are scored on a 10-point scale; 1 point is given when the wound characteristic is similar to 'normal skin', and 10 points are given when it reflects the 'worst wound'. The total score closest to normal skin is 11, and the total score reflecting the worst wound is 110. The other scale is the Vancouver Wound Scale (VSS), consisting of four variables: vascularity, height (thickness), elasticity, and pigmentation. The total score ranges from 0 to 13, with 0 reflecting normal skin and 13 reflecting the worst wound. | Inclusion Criteria: 18-45 years old Patients who had a primary cesarean section at 37w Patients with a Pfannenstiel incision closed subcutaneously | Posted | Mean | Standard Deviation | units on a scale | End of the 2nd month and 6thmonth |
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| Primary | Comparison of Incision Cosmetic Results Between Group 1(Vicryl Suture™(Polyglactin 910)) and Group 2(Prolene Suture™(Polypropylene)) at the End of the 2nd Postoperative Month and at the End of the 6th Postoperative Month by The Vancouver Scar Scale (VSS) | The cosmetic outcome of wound healing was assessed using two different scales. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to assess wound quality. The investigator scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, elevation, and elasticity. All items are scored on a 10-point scale; 1 point is given when the wound characteristic is similar to 'normal skin', and 10 points are given when it reflects the 'worst wound'. The total score closest to normal skin is 11, and the total score reflecting the worst wound is 110. The other scale is the Vancouver Wound Scale (VSS), consisting of four variables: vascularity, height (thickness), elasticity, and pigmentation. The total score ranges from 0 to 13, with 0 reflecting normal skin and 13 reflecting the worst wound. | Inclusion Criteria: 18-45 years old Patients who had a primary cesarean section at 37w Patients with a Pfannenstiel incision closed subcutaneously | Posted | Median | Full Range | units on a scale | End of the 2nd month and 6th month |
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| Primary | Comparison of Incision Cosmetic Results Between Group 1(Vicryl Suture™(Polyglactin 910)) and Group 3(Tekmon Suture™(Poliglekapron 25)) at the End of the 2nd Postoperative Month and at the End of the 6th Postoperative Month by The Vancouver Scar Scale(VSS) | The cosmetic outcome of wound healing was assessed using two different scales. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to assess wound quality. The investigator scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, elevation, and elasticity. All items are scored on a 10-point scale; 1 point is given when the wound characteristic is similar to 'normal skin', and 10 points are given when it reflects the 'worst wound'. The total score closest to normal skin is 11, and the total score reflecting the worst wound is 110. The other scale is the Vancouver Wound Scale (VSS), consisting of four variables: vascularity, height (thickness), elasticity, and pigmentation. The total score ranges from 0 to 13, with 0 reflecting normal skin and 13 reflecting the worst wound. | Inclusion Criteria: 18-45 years old Patients who had a primary cesarean section at 37w Patients with a Pfannenstiel incision closed subcutaneously | Posted | Median | Full Range | units on a scale | End of the 2nd month and 6th month |
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| Primary | Comparison of Incision Cosmetic Results Between Group 2(Prolene Suture™(Polypropylene)) and Group 3(Tekmon Suture™(Poliglekapron 25)) at the End of the 2nd Postoperative Month and at the End of the 6th Postoperative Month by The Vancouver Scar Scale(VSS) | The cosmetic outcome of wound healing was assessed using two different scales. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to assess wound quality. The investigator scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, elevation, and elasticity. All items are scored on a 10-point scale; 1 point is given when the wound characteristic is similar to 'normal skin', and 10 points are given when it reflects the 'worst wound'. The total score closest to normal skin is 11, and the total score reflecting the worst wound is 110. The other scale is the Vancouver Wound Scale (VSS), consisting of four variables: vascularity, height (thickness), elasticity, and pigmentation. The total score ranges from 0 to 13, with 0 reflecting normal skin and 13 reflecting the worst wound. | Inclusion Criteria: 18-45 years old Patients who had a primary cesarean section at 37w Patients with a Pfannenstiel incision closed subcutaneously | Posted | Median | Full Range | units on a scale | End of the 2nd month and 6th month |
|
6 months
Other (Not Including Serious) Adverse Events
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 (Vicryl Suture™(Polyglactin 910)) | The group of patients who had a cesarean section for the first time and whose skin incision was closed with Vicryl suture™ (Polyglactin 910) Evaluation of wound infection at the 10th postoperative day control: Discharge, redness, increased temperature and opening were accepted as wound infection. Evaluation of the cosmetic results of the incision line in all groups at the 2nd and 6th month postoperative controls: The cosmetic results of wound healing are two different It was evaluated with a scale. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to evaluate scar quality. The researcher scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, relief, and flexibility. All items are scored on a 10-point multiple scale; 1 point is given when the scar characteristic resembles 'normal skin', and 10 points are given when it reflects the 'worst scar'. All items are summed to determine the total scar score; a higher score represents worse scar quality. The Vancouver scar scale (VSS) consists of four variables: vascularity, height (thickness), elasticity and pigmentation. The total score ranges from 0 to 14, with a score of 0 reflecting normal skin. | 0 | 85 | 0 | 85 | 12 | 85 |
| EG001 | Group 2 (Prolene Suture™(Polypropylene)) | The group of patients who had a cesarean section for the first time and whose skin incision was closed with Prolene suture™ (polypropylene) Evaluation of wound infection at the 10th postoperative day control: Discharge, redness, increased temperature and opening were accepted as wound infection. Evaluation of the cosmetic results of the incision line in all groups at the 2nd and 6th month postoperative controls: The cosmetic results of wound healing are two different It was evaluated with a scale. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to evaluate scar quality. The researcher scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, relief, and flexibility. All items are scored on a 10-point multiple scale; 1 point is given when the scar characteristic resembles 'normal skin', and 10 points are given when it reflects the 'worst scar'. All items are summed to determine the total scar score; a higher score represents worse scar quality. The Vancouver scar scale (VSS) consists of four variables: vascularity, height (thickness), elasticity and pigmentation. The total score ranges from 0 to 14, with a score of 0 reflecting normal skin. | 0 | 87 | 0 | 87 | 5 | 87 |
| EG002 | Group 3 (Monocryl Suture™ (Polyglecaprone 25)) | The group of patients who had a cesarean section for the first time and whose skin incision was closed with Tekmon suture™ (Polyglecaprone 25) Evaluation of wound infection at the 10th postoperative day control: Discharge, redness, increased temperature and opening were accepted as wound infection. Evaluation of the cosmetic results of the incision line in all groups at the 2nd and 6th month postoperative controls: The cosmetic results of wound healing are two different It was evaluated with a scale. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to evaluate scar quality. The researcher scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itching, color, thickness, relief, and flexibility. All items are scored on a 10-point multiple scale; 1 point is given when the scar characteristic resembles 'normal skin', and 10 points are given when it reflects the 'worst scar'. All items are summed to determine the total scar score; a higher score represents worse scar quality. The Vancouver scar scale (VSS) consists of four variables: vascularity, height (thickness), elasticity and pigmentation. The total score ranges from 0 to 14, with a score of 0 reflecting normal skin. | 0 | 79 | 0 | 79 | 2 | 79 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dehiscence and discharge | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Apse | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Hematom | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Ayşenur Çalış Özbayram | Başakşehir Çam Ve Sakura Şehir Hastanesi | +905549707052 | draysenurcalis@gmail.com |
| Aug 18, 2025 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D007239 | Infections |
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| OG001 | Group 2 (Prolene Suture™(Polypropylene)) | The group of patients who had a cesarean section for the first time and whose skin incision was closed with Prolene suture™ (polypropylene) Evaluation of cosmetic outcomes of the incision line in all groups at 2 and 6 months postoperatively: Cosmetic outcomes of wound healing were assessed using two different scales. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to assess scar quality. The examiner scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itch, color, thickness, relief, and flexibility. A score of 1 is given for all items indicating a scar characteristic similar to normal skin, and 10 for a scar characteristic reflecting the worst scar. All items are summed to determine a total scar score; a higher score represents worse scar quality. The Vancouver Scar Scale (VSS) consists of four variables: vascularization, height (thickness), elasticity, and pigmentation. The total score ranges from 0 to 14, with a score of 0 reflecting normal skin and a higher score representing worse scar quality. |
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| OG001 | Group 3 (Monocryl Suture™ (Polyglecaprone 25)) | The group of patients who had a cesarean section for the first time and whose skin incision was closed with Tekmon suture™ (Polyglecaprone 25) Evaluation of cosmetic outcomes of the incision line in all groups at 2 and 6 months postoperatively: Cosmetic outcomes of wound healing were assessed using two different scales. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to assess scar quality. The examiner scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itch, color, thickness, relief, and flexibility. A score of 1 is given for all items indicating a scar characteristic similar to normal skin, and 10 for a scar characteristic reflecting the worst scar. All items are summed to determine a total scar score; a higher score represents worse scar quality. The Vancouver Scar Scale (VSS) consists of four variables: vascularization, height (thickness), elasticity, and pigmentation. The total score ranges from 0 to 14, with a score of 0 reflecting normal skin and a higher score representing worse scar quality. |
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| OG001 | Group 3 (Monocryl Suture™ (Polyglecaprone 25)) | The group of patients who had a cesarean section for the first time and whose skin incision was closed with Tekmon suture™ (Polyglecaprone 25) Evaluation of cosmetic outcomes of the incision line in all groups at 2 and 6 months postoperatively: Cosmetic outcomes of wound healing were assessed using two different scales. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to assess scar quality. The examiner scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itch, color, thickness, relief, and flexibility. A score of 1 is given for all items indicating a scar characteristic similar to normal skin, and 10 for a scar characteristic reflecting the worst scar. All items are summed to determine a total scar score; a higher score represents worse scar quality. The Vancouver Scar Scale (VSS) consists of four variables: vascularization, height (thickness), elasticity, and pigmentation. The total score ranges from 0 to 14, with a score of 0 reflecting normal skin and a higher score representing worse scar quality. |
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| OG001 | Group 2 (Prolene Suture™(Polypropylene)) | The group of patients who had a cesarean section for the first time and whose skin incision was closed with Prolene suture™ (polypropylene) Evaluation of cosmetic outcomes of the incision line in all groups at 2 and 6 months postoperatively: Cosmetic outcomes of wound healing were assessed using two different scales. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to assess scar quality. The examiner scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itch, color, thickness, relief, and flexibility. A score of 1 is given for all items indicating a scar characteristic similar to normal skin, and 10 for a scar characteristic reflecting the worst scar. All items are summed to determine a total scar score; a higher score represents worse scar quality. The Vancouver Scar Scale (VSS) consists of four variables: vascularization, height (thickness), elasticity, and pigmentation. The total score ranges from 0 to 14, with a score of 0 reflecting normal skin and a higher score representing worse scar quality. |
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| OG001 | Group 3 (Tekmon Suture™ (Polyglecaprone 25)) | The group of patients who had a cesarean section for the first time and whose skin incision was closed with Tekmon suture™ (Polyglecaprone 25) Evaluation of cosmetic outcomes of the incision line in all groups at 2 and 6 months postoperatively: Cosmetic outcomes of wound healing were assessed using two different scales. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to assess scar quality. The examiner scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itch, color, thickness, relief, and flexibility. A score of 1 is given for all items indicating a scar characteristic similar to normal skin, and 10 for a scar characteristic reflecting the worst scar. All items are summed to determine a total scar score; a higher score represents worse scar quality. The Vancouver Scar Scale (VSS) consists of four variables: vascularization, height (thickness), elasticity, and pigmentation. The total score ranges from 0 to 14, with a score of 0 reflecting normal skin and a higher score representing worse scar quality. |
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| OG001 | Group 3 (Monocryl Suture™ (Polyglecaprone 25)) | The group of patients who had a cesarean section for the first time and whose skin incision was closed with Tekmon suture™ (Polyglecaprone 25) Evaluation of cosmetic outcomes of the incision line in all groups at 2 and 6 months postoperatively: Cosmetic outcomes of wound healing were assessed using two different scales. The Patient and Observer Assessment Scale (POSAS) is a questionnaire developed to assess scar quality. The examiner scores six items: vascularization, pigmentation, thickness, surface roughness, elasticity, and surface area. The participant scores six items: pain, itch, color, thickness, relief, and flexibility. A score of 1 is given for all items indicating a scar characteristic similar to normal skin, and 10 for a scar characteristic reflecting the worst scar. All items are summed to determine a total scar score; a higher score represents worse scar quality. The Vancouver Scar Scale (VSS) consists of four variables: vascularization, height (thickness), elasticity, and pigmentation. The total score ranges from 0 to 14, with a score of 0 reflecting normal skin and a higher score representing worse scar quality. |
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