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

Completed · Not applicable

Conditions studied: Hypertrophic Skin Condition of Anterior Abdomen

In brief

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

Key facts

Study ID

NCT05266053

Run by

Indiana University

People needed

24

Starts

2022-07-28

Expected to finish

2023-05-01

Last updated by the study team

2024-09-03

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Eskenazi Hospital — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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