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The goal of this randomized control trial is to compare two skin closure techniques after cesarean section. Both techniques are currently in wide use but no comparison between the two was reasserted yet. The two techniques are- First technique is intracuticular suture using monofilament suture, Second technique is intracuticular suture and biological adhesive material. The investigators' primary outcome is to explore the rate of skin scar complications to understand whether one technique has a lower complication rate then the other. The secondary outcomes is to check whether one technique is better then the other in terms of patients' satisfaction, convenience and scar healing and appearance.
Patients at the age of 18 and above, undergoing elective cesarean section at the Hadassa medical center, can participate.
participants will be randomly assigned to one of the groups- the firs or the second technique.
Patients will be asked to fill out a questionnaire on POD 2 and attend a check-up appointment in-person with their surgeon 6-8 weeks post surgery. at the check-up the patient will be asked to fill out another questionnaire and undergo a scar appearance evaluation by the surgeon.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Skin closure using intracuticular suture alone | No Intervention | this group will undergo skin closure at the end of the cesarean section using intracuticular suture alone using monofilament suture. | |
| Skin closure using intracuticular suture and biological adhesive material in addition | Experimental | this group will undergo skin closure at the end of the cesarean section using intracuticular suture using monofilament suture and biological adhesive material in addition. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dermabond | Other | The intervention is the addition of skin adhesive biological material on top of an intracuticular suture in skin closure after cesarean section |
|
| Measure | Description | Time Frame |
|---|---|---|
| Skin wound complecations | Any skin complications including superficial infection, deep infection, seroma, skin open, the need for antibiotics and skin related complaints including rash, itching, discharge. | From the surgery and up to 8 weeks post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery and connivance of the patient at POD 2 | The investigators will assess the satisfaction of the patient on POD 2 using a Likert score based questionnaire designed for the study. Each question is graded between 0-10, the summery of all questions is the grade of the questionnaire | From the day of the surgery up to 8 weeks post surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Efrat Shekel, MD | Contact | +972507680404 | efratsh14@gmail.com | |
| Doron Kabiri, MD, MPH | Contact | +972508946898 | doronkabiri@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hadassah University Medical Center, Ein Karem Campus | Recruiting | Jerusalem | 9112001 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36355319 | Background | Carriere ME, Mokkink LB, Tyack Z, Westerman MJ, Pijpe A, Pleat J, van de Kar AL, Brown J, de Vet HCW, van Zuijlen PPM. Development of the Patient Scale of the Patient and Observer Scar Assessment Scale (POSAS) 3.0: a qualitative study. Qual Life Res. 2023 Feb;32(2):583-592. doi: 10.1007/s11136-022-03244-6. Epub 2022 Nov 10. | |
| 8537427 |
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All IPD included in the statistical analysis will be shared
The IPD will be available from January 2027
people interested in the IPD will be able to access it upon request
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C100832 | octyl 2-cyanoacrylate |
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|
| Patients' satisfaction from their recovery and scar healing process 6-8 weeks post surgery |
The investigators will assess the satisfaction of the patient 6-8 weeks post the surgery using the POSAS 3.0 (patient & observer scar assessment scale)- the patient questionnaire for generic scar. the score for this questionnaire rages between 16 to 80, the lower the score, the better scar outcomes |
| 6-8 weeks post surgery |
| Scar appearance after 6-8 weeks | The investigators will assess the scar healing and appearance using the Vancouver Scar Scale 6-8 weeks post surgery. the assessment will be made by the surgeon, in person. The grade for this questionnaire ranges between 0 and 13, the lower the score, the better outcome. | 6-8 weeks post surgery |
| Baryza MJ, Baryza GA. The Vancouver Scar Scale: an administration tool and its interrater reliability. J Burn Care Rehabil. 1995 Sep-Oct;16(5):535-8. doi: 10.1097/00004630-199509000-00013. |
| 23921089 | Background | Feese CA, Johnson S, Jones E, Lambers DS. A randomized trial comparing metallic and absorbable staples for closure of a Pfannenstiel incision for cesarean delivery. Am J Obstet Gynecol. 2013 Dec;209(6):556.e1-5. doi: 10.1016/j.ajog.2013.08.001. Epub 2013 Aug 3. |
| 20417924 | Background | 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. |
| 24807325 | Background | Mackeen AD, Khalifeh A, Fleisher J, Vogell A, Han C, Sendecki J, Pettker C, Leiby BE, Baxter JK, Sfakianaki A, Berghella V. Suture compared with staple skin closure after cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2014 Jun;123(6):1169-1175. doi: 10.1097/AOG.0000000000000227. |
| 22910336 | Background | de Graaf IM, Oude Rengerink K, Wiersma IC, Donker ME, Mol BW, Pajkrt E. Techniques for wound closure at caesarean section: a randomized clinical trial. Eur J Obstet Gynecol Reprod Biol. 2012 Nov;165(1):47-52. doi: 10.1016/j.ejogrb.2012.07.019. Epub 2012 Aug 19. |
| 34130991 | Background | Betran AP, Ye J, Moller AB, Souza JP, Zhang J. Trends and projections of caesarean section rates: global and regional estimates. BMJ Glob Health. 2021 Jun;6(6):e005671. doi: 10.1136/bmjgh-2021-005671. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |