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Completed

NCT Number: NCT05266053

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

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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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Eskenazi Hospital

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PICO 7 dressing

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.

Standard wound dressing

Other

Standard abdominal dressing at the time of cesarean

Primary outcomes

  1. Subjective Cosmetic Result

    Time frame: Week 6

    Patients were evaluated using the Patient and Observer Scar Assessment (POSAS) Scale.

    Patient is asked as series of subjective questions regarding (vascularity, pigmentation, thickness, relief, pliability, surface area). Participants respond with a scale of 1 - 10 with 10 as the most severe appearance and 1 as the least severe appearance. These scores are summed for a total value of 6 (total best outcome) through 60 (total worst outcome).

    The full range provided reflects the actual collected data from the participants.

  2. Patient Satisfaction With Wound Appearance

    Time frame: Week 6

    Scale of 1 - 10 with 1 being least satisfied and 10 being most satisfied

Secondary outcomes

  1. Procedure Time in Minutes

    Time frame: Start of surgery until application of wound vac immediately post-procedure

    Procedure time in minutes

  2. Analog Pain Scores 48 Hours

    Time frame: 48 hours after surgery

    Participants respond with a scale of 1 - 10 with 10 as most severe and 1 as not at all.

    The full range provided reflects the actual collected data from the participants.

  3. Analog Pain Scores 72 Hours

    Time frame: 72 hours after surgery

    Participants respond with a scale of 1 - 10 with 10 as the most severe and 1 being no pain at all.

    The full range provided reflects the actual collected data from the participants.

  4. Analog Pain Scores @4 Weeks

    Time frame: 4 weeks after surgery at postpartum visit

    Participants respond with a scale of 1 - 10 with 10 as the most severe and 1 being no pain at all.

    The full range provided reflects the actual collected data from the participants.

  5. Analog Pain Scores @6 Weeks

    Time frame: 6 weeks after surgery at postpartum visit

    Participants respond with a scale of 1 - 10 with 10 as the most severe and 1 being no pain at all.

    The full range provided reflects the actual collected data from the participants.

  6. Incision Healing Complications up to 42 Days Postoperatively

    Time frame: 42 day after surgery

    Number of Participants with Incision Healing Complications up to 42 Days Postoperatively

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 4, 2022
Registry last updated
Sep 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.