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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-28

Study Completion Date

2023-05-01

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

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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.

Conditions

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Hypertrophic Skin Condition of Anterior Abdomen

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Treatment Group

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

Group Type EXPERIMENTAL

PICO 7 dressing

Intervention Type 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.

Control Group

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

Group Type OTHER

Standard wound dressing

Intervention Type OTHER

Standard abdominal dressing at the time of cesarean

Interventions

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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.

Intervention Type DEVICE

Standard wound dressing

Standard abdominal dressing at the time of cesarean

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes