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NCT05266053 · ClinicalTrials.gov registry record · NA
Negative Pressure Wound Therapy-PICO: Cosmesis in Repeat C-Sections
A NA study, sponsored by Indiana University.
- Completed
- Registry status
- NA
- Development phase
- 24
- Enrollment target
NCT05266053: Completed NA study, sponsored by Indiana University.
NCT05266053 is a NA study that has completed, run by Indiana University. The registered enrollment target is 24 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05266053, a NA study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
Study 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
Primary Outcome
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 d
Interventions
- DEVICE PICO 7 dressing
- OTHER Standard wound dressing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2022-07-28 |
| Est. Completion | 2023-05-01 |
| Phase | NA |
What the finished NCT05266053 record still lists
NCT05266053 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which PICO 7 dressing is the first listed.
NCT05266053 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05266053 about?
NCT05266053 is a clinical study titled "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 con...
What is the current status of trial NCT05266053?
This trial is currently completed. It is a NA study. The enrollment target is 24 participants. The study started on 2022-07-28. Estimated completion is 2023-05-01.
What interventions are being tested in trial NCT05266053?
The interventions under investigation include: PICO 7 dressing (DEVICE), Standard wound dressing (OTHER).
Who is sponsoring clinical trial NCT05266053?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05266053's enrollment target sits among peer trials
24 1736th of 2000 higher than 246 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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