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

Indiana University

Status: Completed

Conditions: Hypertrophic Skin Condition of Anterior Abdomen

Treatments: Device: PICO 7 dressing; Other: Standard wound dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT05266053

2008549700

Details and patient eligibility

About

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

Full 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. 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.

Enrollment: 24 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Treatment Group

Experimental group

Description:

This group will have a PICO negative pressure wound treatment device applied to their surgical wound site.

Treatment:

Device: PICO 7 dressing

Control Group

Other group

Description:

Standard Intervention. This group will have a standard wound dressing (gauze, bandage) applied to their surgical wound site.

Treatment:

Other: Standard wound dressing