Status:
COMPLETED
Negative Pressure Wound Therapy-PICO: Cosmesis in Repeat C-Sections
Lead Sponsor:
Indiana University
Conditions:
Hypertrophic Skin Condition of Anterior Abdomen
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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 freque...
Detailed Description
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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05266053
Start Date
July 28 2022
End Date
May 1 2023
Last Update
September 3 2024
Active Locations (1)
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1
Eskenazi Hospital
Indianapolis, Indiana, United States, 46202