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There are millions of births each year with 32% of women undergoing cesarean sections (C-sections), which results in skin scarring. Repeat C-sections increased by 178% from 1979-2010. Given the frequency of C-sections, it is important to achieve a desirable cosmetic outcome.
The PICO 7 dressing consists of a negative pressure wound therapy pump (NPWT) connected to an absorbent gentle adhesive dressing that is applied to a wound. When the pump is activated, it acts by pulling excess fluid from the wound. The dressing absorbs this fluid and helps to prevent bacteria from entering the wound. It has been shown to prevent wound infections and promote healing. This study aims to compare the aesthetic appearance by using The Patient and Observer Scar Assessment Scale (POSAS) scar assessment scale following closed incision negative pressure therapy with a PICO 7 dressing to the standard abdominal dressing in women undergoing repeat cesarean sections
Single, randomized controlled trial in women undergoing a repeat cesarean delivery. Women will be randomized to placement of a PICO 7 dressing or a standard abdominal dressing at the time of cesarean. The standard abdominal dressing will be removed approximately on postoperative day (POD) 1-2 and the PICO 7 dressing will be removed approximately on POD 3-4 (prior to discharge). If the patient with a PICO dressing remains inpatient for longer than 7 postoperative days, the PICO dressing will be removed prior to POD 7, in accordance with device instructions. Participants in both groups will be sent POSAS surveys at the two, four and six week visit window with primary outcome being aesthetic appearance (cosmesis) at six weeks. Observers (healthcare providers) will complete a POSAS survey at the postpartum visit (~4-6 weeks postoperative) to rate scar quality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | This group will have a PICO negative pressure wound treatment device applied to their surgical wound site. |
|
| Control Group | Other | Standard Intervention. This group will have a standard wound dressing (gauze, bandage) applied to their surgical wound site. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PICO 7 dressing | Device | The PICO 7 dressing consists of a negative pressure wound therapy pump (NPWT) connected to an absorbent gentle adhesive dressing that is applied to a wound. When the pump is activated, it acts by pulling excess fluid from the wound. The dressing absorbs this fluid and helps to prevent bacteria from entering the wound. It has been shown to prevent wound infections and promote healing. |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Cosmetic Result | Patients were evaluated using the Patient and Observer Scar Assessment (POSAS) Scale. Patient is asked as series of subjective questions regarding (vascularity, pigmentation, thickness, relief, pliability, surface area). Participants respond with a scale of 1 - 10 with 10 as the most severe appearance and 1 as the least severe appearance. These scores are summed for a total value of 6 (total best outcome) through 60 (total worst outcome). The full range provided reflects the actual collected data from the participants. | Week 6 |
| Patient Satisfaction With Wound Appearance | Scale of 1 - 10 with 1 being least satisfied and 10 being most satisfied | Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure Time in Minutes | Procedure time in minutes | Start of surgery until application of wound vac immediately post-procedure |
| Analog Pain Scores 48 Hours | Participants respond with a scale of 1 - 10 with 10 as most severe and 1 as not at all. The full range provided reflects the actual collected data from the participants. |
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Inclusion Criteria:
Exclusion Criteria:
Patients with malignancy in the wound bed or margins of the wound
Non-enteric and unexplored fistulas
Necrotic tissue with eschar present
Exposed arteries, veins, nerves or organs
Exposed anastomotic sites
Cellulitis or evidence of active infection
Known allergy to adhesive tape
Patient unwilling to follow-up
Contraindication to NPWT
Pregnant transgender males may participate in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Mims, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eskenazi Hospital | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19501559 | Background | Brown BC, Moss TP, McGrouther DA, Bayat A. Skin scar preconceptions must be challenged: importance of self-perception in skin scarring. J Plast Reconstr Aesthet Surg. 2010 Jun;63(6):1022-9. doi: 10.1016/j.bjps.2009.03.019. Epub 2009 Jun 5. | |
| 23262925 | Background | Figueroa D, Jauk VC, Szychowski JM, Garner R, Biggio JR, Andrews WW, Hauth J, Tita AT. Surgical staples compared with subcuticular suture for skin closure after cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2013 Jan;121(1):33-8. doi: 10.1097/aog.0b013e31827a072c. |
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There are no pre-assignment factors that impact participant enrollment.
Patients recruited from medical clinic and in-patient admissions.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group | This group will have a PICO negative pressure wound treatment device applied to their surgical wound site. PICO 7 dressing: The PICO 7 dressing consists of a negative pressure wound therapy pump (NPWT) connected to an absorbent gentle adhesive dressing that is applied to a wound. When the pump is activated, it acts by pulling excess fluid from the wound. The dressing absorbs this fluid and helps to prevent bacteria from entering the wound. It has been shown to prevent wound infections and promote healing. |
| FG001 | Control Group | Standard Intervention. This group will have a standard wound dressing (gauze, bandage) applied to their surgical wound site. Standard wound dressing: Standard abdominal dressing at the time of cesarean |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group | This group will have a PICO negative pressure wound treatment device applied to their surgical wound site. PICO 7 dressing: The PICO 7 dressing consists of a negative pressure wound therapy pump (NPWT) connected to an absorbent gentle adhesive dressing that is applied to a wound. When the pump is activated, it acts by pulling excess fluid from the wound. The dressing absorbs this fluid and helps to prevent bacteria from entering the wound. It has been shown to prevent wound infections and promote healing. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Subjective Cosmetic Result | Patients were evaluated using the Patient and Observer Scar Assessment (POSAS) Scale. Patient is asked as series of subjective questions regarding (vascularity, pigmentation, thickness, relief, pliability, surface area). Participants respond with a scale of 1 - 10 with 10 as the most severe appearance and 1 as the least severe appearance. These scores are summed for a total value of 6 (total best outcome) through 60 (total worst outcome). The full range provided reflects the actual collected data from the participants. | The only subjects analyzed were those that were evaluated in week 6 | Posted | Median | Full Range | units on a scale | Week 6 |
|
7 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Group | This group will have a PICO negative pressure wound treatment device applied to their surgical wound site. PICO 7 dressing: The PICO 7 dressing consists of a negative pressure wound therapy pump (NPWT) connected to an absorbent gentle adhesive dressing that is applied to a wound. When the pump is activated, it acts by pulling excess fluid from the wound. The dressing absorbs this fluid and helps to prevent bacteria from entering the wound. It has been shown to prevent wound infections and promote healing. |
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Lack of self guided patient participation or return of survey request.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lisa Mims - Principal Investigator | Indiana University | 7733074863 | lamims@iupui.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 16, 2022 | Jul 14, 2024 | Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 25, 2024 | May 26, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 16, 2022 | Aug 28, 2024 | ICF_004.pdf |
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Women will be randomized to placement of a PICO 7 dressing or a standard abdominal dressing at the time of cesarean. The standard abdominal dressing will be removed approximately on postoperative day (POD) 1-2 and the PICO 7 dressing will be removed approximately on POD 3-4 (prior to discharge). If the patient with a PICO dressing remains inpatient for longer than 7 postoperative days, the PICO dressing will be removed prior to POD 7, in accordance with device instructions. Participants in both groups will be sent POSAS surveys at the two, four and six week visit window with primary outcome being aesthetic appearance (cosmesis) at six weeks. Observers (healthcare providers) will complete a POSAS survey at the postpartum visit (~4-6 weeks postoperative) to rate scar quality.
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|
| Standard wound dressing | Other | Standard abdominal dressing at the time of cesarean |
|
| 48 hours after surgery |
| Analog Pain Scores 72 Hours | Participants respond with a scale of 1 - 10 with 10 as the most severe and 1 being no pain at all. The full range provided reflects the actual collected data from the participants. | 72 hours after surgery |
| Analog Pain Scores @4 Weeks | Participants respond with a scale of 1 - 10 with 10 as the most severe and 1 being no pain at all. The full range provided reflects the actual collected data from the participants. | 4 weeks after surgery at postpartum visit |
| Analog Pain Scores @6 Weeks | Participants respond with a scale of 1 - 10 with 10 as the most severe and 1 being no pain at all. The full range provided reflects the actual collected data from the participants. | 6 weeks after surgery at postpartum visit |
| Incision Healing Complications up to 42 Days Postoperatively | Number of Participants with Incision Healing Complications up to 42 Days Postoperatively | 42 day after surgery |
| 26994715 | Background | Hyldig N, Birke-Sorensen H, Kruse M, Vinter C, Joergensen JS, Sorensen JA, Mogensen O, Lamont RF, Bille C. Meta-analysis of negative-pressure wound therapy for closed surgical incisions. Br J Surg. 2016 Apr;103(5):477-86. doi: 10.1002/bjs.10084. |
| 30066454 | Background | Hyldig N, Vinter CA, Kruse M, Mogensen O, Bille C, Sorensen JA, Lamont RF, Wu C, Heidemann LN, Ibsen MH, Laursen JB, Ovesen PG, Rorbye C, Tanvig M, Joergensen JS. Prophylactic incisional negative pressure wound therapy reduces the risk of surgical site infection after caesarean section in obese women: a pragmatic randomised clinical trial. BJOG. 2019 Apr;126(5):628-635. doi: 10.1111/1471-0528.15413. Epub 2018 Sep 7. |
| 29458906 | Background | Ekin M, Dagdeviren H, Caypinar SS, Erdogan B, Ayag ME, Cengiz H, Yasar L, Helvacioglu C. Comparative cosmetic outcome of surgical incisions created by the PEAK Plasma Blade and a scalpel after cesarean section by Patient and Observer Assessment Scale (POSAS): A randomized double blind study. Taiwan J Obstet Gynecol. 2018 Feb;57(1):68-70. doi: 10.1016/j.tjog.2017.12.011. |
| 17230080 | Background | Truong PT, Lee JC, Soer B, Gaul CA, Olivotto IA. Reliability and validity testing of the Patient and Observer Scar Assessment Scale in evaluating linear scars after breast cancer surgery. Plast Reconstr Surg. 2007 Feb;119(2):487-94. doi: 10.1097/01.prs.0000252949.77525.bc. |
| BG001 | Control Group | Standard Intervention. This group will have a standard wound dressing (gauze, bandage) applied to their surgical wound site. Standard wound dressing: Standard abdominal dressing at the time of cesarean |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | 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 |
|
| Region of Enrollment | Number | participants |
|
| Scar Assessment | Patients were evaluated using the Patient and Observer Scar Assessment (POSAS) Scale. Patient is asked as series of subjective questions regarding pain, color, stiffness, thickness, irregularity, itching, and overall impression. Participants respond with a scale of 1 - 10 with 10 as the most severe appearance and 1 as the least severe appearance. These scores are summed for a total value of 6 (total best outcome) through 60 (total worst outcome). The full range provided reflects the actual collected data from the participants. | Subjects analyzed were much lower due to lack of patient response and patients loss to follow up. | Median | Full Range | units on a scale |
|
| OG001 | Control Group | Standard Intervention. This group will have a standard wound dressing (gauze, bandage) applied to their surgical wound site. Standard wound dressing: Standard abdominal dressing at the time of cesarean |
|
|
| Primary | Patient Satisfaction With Wound Appearance | Scale of 1 - 10 with 1 being least satisfied and 10 being most satisfied | Some participants did not complete surveys so the Overall Number of Participants reflects participants with scale data collected. The full range provided reflects the actual collected data from the participants. | Posted | Median | Full Range | score on a scale | Week 6 |
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|
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| Secondary | Procedure Time in Minutes | Procedure time in minutes | Data was not collected. | Posted | Start of surgery until application of wound vac immediately post-procedure |
|
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| Secondary | Analog Pain Scores 48 Hours | Participants respond with a scale of 1 - 10 with 10 as most severe and 1 as not at all. The full range provided reflects the actual collected data from the participants. | No data was collected | Posted | 48 hours after surgery |
|
|
| Secondary | Analog Pain Scores 72 Hours | Participants respond with a scale of 1 - 10 with 10 as the most severe and 1 being no pain at all. The full range provided reflects the actual collected data from the participants. | No Data was collected | Posted | 72 hours after surgery |
|
|
| Secondary | Analog Pain Scores @4 Weeks | Participants respond with a scale of 1 - 10 with 10 as the most severe and 1 being no pain at all. The full range provided reflects the actual collected data from the participants. | Some participants did not complete surveys so the Overall Number of Participants reflects participants with scale data collected. | Posted | Median | Full Range | score on a scale | 4 weeks after surgery at postpartum visit |
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|
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| Secondary | Analog Pain Scores @6 Weeks | Participants respond with a scale of 1 - 10 with 10 as the most severe and 1 being no pain at all. The full range provided reflects the actual collected data from the participants. | Some participants did not complete surveys so the Overall Number of Participants reflects participants with scale data collected | Posted | Median | Full Range | score on a scale | 6 weeks after surgery at postpartum visit |
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| Secondary | Incision Healing Complications up to 42 Days Postoperatively | Number of Participants with Incision Healing Complications up to 42 Days Postoperatively | Some participants did not complete follow up as scheduled. Data analysed reflects participants with collected data. | Posted | Count of Participants | Participants | 42 day after surgery |
|
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| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Control Group | Standard Intervention. This group will have a standard wound dressing (gauze, bandage) applied to their surgical wound site. Standard wound dressing: Standard abdominal dressing at the time of cesarean | 0 | 12 | 0 | 12 | 0 | 12 |
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