18 and older, female only, with Hypertrophic Skin Condition of Anterior Abdomen. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Subjective Cosmetic ResultPrimary· 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.
Group
Value
95% CI
Treatment Group
13
10 – 16.5
Control Group
26.5
16 – 36.5
Patient Satisfaction With Wound AppearancePrimary· Week 6
Scale of 1 - 10 with 1 being least satisfied and 10 being most satisfied
Group
Value
95% CI
Treatment Group
2
2 – 2
Control Group
7
4 – 10
Analog Pain Scores @4 WeeksSecondary· 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.
Group
Value
95% CI
Treatment Group
2
1 – 5
Control Group
6
2 – 10
Analog Pain Scores @6 WeeksSecondary· 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.
Group
Value
95% CI
Treatment
1.5
1 – 3
Control
1.5
1 – 4
Incision Healing Complications up to 42 Days PostoperativelySecondary· 42 day after surgery
Number of Participants with Incision Healing Complications up to 42 Days Postoperatively
Group
Value
95% CI
Treatment Group
0
Control Group
0
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Indiana University
Last refreshed: 3 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05266053.