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

NCT05266053 | Completed Results FDA Device

• 1 other identifier: 2008549700
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 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

Conditions

Hypertrophic Skin Condition of Anterior Abdomen

Outcome Measures

Primary Outcomes (2)

• Subjective Cosmetic Result

  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.

  Week 6

• Patient Satisfaction With Wound Appearance

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

  Week 6

Secondary Outcomes (6)

• Procedure Time in Minutes

  Start of surgery until application of wound vac immediately post-procedure

• Analog Pain Scores 48 Hours

  48 hours after surgery

• Analog Pain Scores 72 Hours

  72 hours after surgery

• Analog Pain Scores @4 Weeks

  4 weeks after surgery at postpartum visit

• Analog Pain Scores @6 Weeks

  6 weeks after surgery at postpartum visit

Study Arms (2)

Treatment Group

EXPERIMENTAL

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

Device: PICO 7 dressing

Control Group

OTHER

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

Other: Standard wound dressing

Interventions

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.

Treatment Group

Standard wound dressing OTHER

Standard abdominal dressing at the time of cesarean

Control Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant transgender males may participate in the study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Eskenazi Hospital

Indianapolis, Indiana, 46202, United States

Location

Related Publications (6)

• Brown BC, Moss TP, McGrouther DA, Bayat A. Skin scar preconceptions must be challenged: importance of self-perception in skin scarring. J Plast Reconstr Aesthet Surg. 2010 Jun;63(6):1022-9. doi: 10.1016/j.bjps.2009.03.019. Epub 2009 Jun 5.

  PMID: 19501559 BACKGROUND

• Figueroa D, Jauk VC, Szychowski JM, Garner R, Biggio JR, Andrews WW, Hauth J, Tita AT. Surgical staples compared with subcuticular suture for skin closure after cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2013 Jan;121(1):33-8. doi: 10.1097/aog.0b013e31827a072c.

  PMID: 23262925 BACKGROUND

• Hyldig N, Birke-Sorensen H, Kruse M, Vinter C, Joergensen JS, Sorensen JA, Mogensen O, Lamont RF, Bille C. Meta-analysis of negative-pressure wound therapy for closed surgical incisions. Br J Surg. 2016 Apr;103(5):477-86. doi: 10.1002/bjs.10084.

  PMID: 26994715 BACKGROUND

• Hyldig N, Vinter CA, Kruse M, Mogensen O, Bille C, Sorensen JA, Lamont RF, Wu C, Heidemann LN, Ibsen MH, Laursen JB, Ovesen PG, Rorbye C, Tanvig M, Joergensen JS. Prophylactic incisional negative pressure wound therapy reduces the risk of surgical site infection after caesarean section in obese women: a pragmatic randomised clinical trial. BJOG. 2019 Apr;126(5):628-635. doi: 10.1111/1471-0528.15413. Epub 2018 Sep 7.

  PMID: 30066454 BACKGROUND

• Ekin M, Dagdeviren H, Caypinar SS, Erdogan B, Ayag ME, Cengiz H, Yasar L, Helvacioglu C. Comparative cosmetic outcome of surgical incisions created by the PEAK Plasma Blade and a scalpel after cesarean section by Patient and Observer Assessment Scale (POSAS): A randomized double blind study. Taiwan J Obstet Gynecol. 2018 Feb;57(1):68-70. doi: 10.1016/j.tjog.2017.12.011.

  PMID: 29458906 BACKGROUND

• Truong PT, Lee JC, Soer B, Gaul CA, Olivotto IA. Reliability and validity testing of the Patient and Observer Scar Assessment Scale in evaluating linear scars after breast cancer surgery. Plast Reconstr Surg. 2007 Feb;119(2):487-94. doi: 10.1097/01.prs.0000252949.77525.bc.

  PMID: 17230080 BACKGROUND

Limitations and Caveats

Lack of self guided patient participation or return of survey request.

Results Point of Contact

• Title: Dr. Lisa Mims - Principal Investigator
• Organization: Indiana University

lamims@iupui.edu

7733074863

Study Officials

• Lisa Mims, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: March 4, 2022
• Study Start: July 28, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: September 3, 2024
• Results First Posted: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)