Negative Pressure Wound Therapy-PICO: Cosmesis in Repeat C-Sections

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Negative Pressure Wound Therapy-PICO: Cosmesis in Repeat C-Sections

Conditions
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Hypertrophic Skin Condition of Anterior Abdomen

Intervention / Treatment
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* Device: PICO 7 dressing
* Other: Standard wound dressing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled or non-labor repeat cesarean delivery One or more prior cesarean section(s) with prior pfannenstiel incision scar Gestational age > 23 weeks Age 18 and older 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 Bleeding disorder Therapeutic anticoagulation Allergy to any component of the dressing (perhaps list these as you will need to know to confirm eligibility of each patient) Prior irradiated skin

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>This group will have a PICO negative pressure wound treatment device applied to their surgical wound site. | Device: PICO 7 dressing<br>* 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.<br>|
| Other: Control Group<br>Standard Intervention. This group will have a standard wound dressing (gauze, bandage) applied to their surgical wound site. | Other: Standard wound dressing<br>* Standard abdominal dressing at the time of cesarean<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective cosmetic result | Patient and Observer Scar Assessment Scale POSAS scale of 1 - 10 with 10 as the most severe appearance and 1 as the least severe appearance utilizing an average of 6 individual indicators on a similar scale 1 to 10 (vascularity, pigmentation, thickness, relief, pliability, surface area) | Week 6 | 
| Patient Satisfaction with wound appearance | Scale of 1 - 10 with 1 being least satisfied and 10 being most satisfied | Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure time in minutes | Procedure time in minutes | Week 6 | 
| Analog pain scores 48 hours | Analog pain scores 48 hours | 48 hours after surgery | 
| Analog pain scores 72 hours | Analog pain scores 72 hours | 72 hours after surgery | 
| Analog pain scores @4 weeks | Analog pain scores @4 weeks (postpartum visit) | 4 weeks after surgery at postpartum visit | 
| Analog pain scores @6 weeks | Analog pain scores @6 weeks (postpartum visit) | 6 weeks after surgery at postpartum visit | 
| Incision healing complications up to 42 days postoperatively | Incision healing complications up to 42 days postoperatively | 42 day after surgery |