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

Study Overview

• Status: Completed
• Conditions: Hypertrophic Skin Condition of Anterior Abdomen
• Intervention / Treatment: Device: PICO 7 dressing; Other: Standard wound dressing

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Eskenazi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group; This group will have a PICO negative pressure wound treatment device applied to their surgical wound site.	Device: 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.
Other: Control Group; Standard Intervention. This group will have a standard wound dressing (gauze, bandage) applied to their surgical wound site.	Other: Standard wound dressing; Standard abdominal dressing at the time of cesarean

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure Time in Minutes	Procedure time in minutes	Start of surgery until application of wound vac immediately post-procedure
Analog Pain Scores 48 Hours	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.	48 hours after surgery
Analog Pain Scores 72 Hours	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.	72 hours after surgery
Analog Pain Scores @4 Weeks	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 weeks after surgery at postpartum visit
Analog Pain Scores @6 Weeks	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 weeks after surgery at postpartum visit
Incision Healing Complications up to 42 Days Postoperatively	Number of Participants with Incision Healing Complications up to 42 Days Postoperatively	42 day after surgery

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: Lisa Mims, MD, Indiana University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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. Erratum In: Obstet Gynecol. 2013 May;121(5):1113.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2022
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: February 1, 2022
• First Submitted That Met QC Criteria: March 2, 2022
• First Posted (Actual): March 4, 2022

Study Record Updates

• Last Update Posted (Actual): September 3, 2024
• Last Update Submitted That Met QC Criteria: August 28, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases
• Other Study ID Numbers: 2008549700

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No