N/A
N=24
Negative Pressure Wound Therapy-PICO: Cosmesis in Repeat C-Sections
Hypertrophic Skin Condition of Anterior Abdomen
Bottom Line
View on ClinicalTrials.gov: NCT05266053 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Subjective Cosmetic Result — 13; 26.5 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PICO 7 dressing (Device); Standard wound dressing (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Indiana University
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjective Cosmetic Result |
13; 26.5 | — |
| PRIMARY Patient Satisfaction With Wound Appearance |
2; 7 | — |
| SECONDARY Procedure Time in Minutes |
— | — |
| SECONDARY Analog Pain Scores 48 Hours |
— | — |
| SECONDARY Analog Pain Scores 72 Hours |
— | — |
| SECONDARY Analog Pain Scores @4 Weeks |
2; 6 | — |
| SECONDARY Analog Pain Scores @6 Weeks |
1.5; 1.5 | — |
| SECONDARY Incision Healing Complications up to 42 Days Postoperatively |
0; 0 | — |
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
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
Data sourced from ClinicalTrials.gov (NCT05266053). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.