Clinical trial NCT05266053: Negative Pressure Wound Therapy-PICO: Cosmesis in Repeat C-Sections
Official title: Negative Pressure Wound Therapy-PICO: Cosmesis in Repeat C-Sections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertrophic Skin Condition of Anterior Abdomen
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Subjective Cosmetic Result
timeFrame: Week 6
measure: Patient Satisfaction With Wound Appearance
timeFrame: Week 6
Secondary outcomes:
measure: Procedure Time in Minutes
timeFrame: Start of surgery until application of wound vac immediately post-procedure
measure: Analog Pain Scores 48 Hours
timeFrame: 48 hours after surgery
measure: Analog Pain Scores 72 Hours
timeFrame: 72 hours after surgery
measure: Analog Pain Scores @4 Weeks
timeFrame: 4 weeks after surgery at postpartum visit
measure: Analog Pain Scores @6 Weeks
timeFrame: 6 weeks after surgery at postpartum visit
measure: Incision Healing Complications up to 42 Days Postoperatively
timeFrame: 42 day after surgery
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Eskenazi Hospital
state: Indiana
Study officials:
affiliation: Indiana University
name: Lisa Mims, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.