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NCT01640366 · ClinicalTrials.gov registry record · NA
PICO Breast Reduction Clinical Study Looking at Incision Healing Complications
A NA study of Delayed Healing, sponsored by Smith & Nephew.
- Completed
- Registry status
- NA
- Development phase
- 200
- Enrollment target
- 6
- Study locations
NCT01640366: Completed NA study of Delayed Healing, sponsored by Smith & Nephew.
NCT01640366 is a NA study of Delayed Healing that has completed, run by Smith & Nephew. The registered enrollment target is 200 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower). The trial reports 6 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01640366, a NA study of Delayed Healing, has completed, sponsored by Smith & Nephew.
- COMPLETED
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
- 6
- Study locations
Study Summary
The purpose of this study is to see if the use of a single-use negative pressure wound therapy system (NPWT) will have an effect on the reduction of post-surgical incision healing complications following breast reduction surgery and to assess the medium-term aesthetic appearance and quality of the resultant scar, compared with standard of care dressings.
Primary Outcome
The primary variable of whether or not the incision developed a healing complication within 21 days of surgery was defined as the presence of at least one of the following: 1. Infection (superficial or deep), 2. Dehiscence (partial, superficial or deep), 3. Delayed healing (defined as incision not closed within 7 days of the first surgical procedure). All participants received both PICO and standard care dressings simultaneously during the course of the study; randomized to either right breast
Conditions Studied
Interventions
- DEVICE PICO
Study Locations (6)
Other
- CHU de Nantes Hôtel Dieu - Nantes
- Academisch Ziekenhuis Maastricht (AZM) - Maastricht
- University of Cape Town - Cape Town
Illinois
- Northwestern University Feinberg School of Medicine - Chicago
New York
- Montefiore - The Bronx
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2012-06 |
| Est. Completion | 2014-07 |
| Phase | NA |
What the finished NCT01640366 record still lists
NCT01640366 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Delayed Healing appearing as the primary indexed condition, and to 1 intervention - of which PICO is the first listed.
NCT01640366 lists 6 locations in 4 states (Other, Illinois, New York).
Frequently Asked Questions
What is clinical trial NCT01640366 about?
NCT01640366 is a clinical study titled "PICO Breast Reduction Clinical Study Looking at Incision Healing Complications". The purpose of this study is to see if the use of a single-use negative pressure wound therapy system (NPWT) will have an effect on the reduction of post-surgical incision healing complications following breast reduction surgery and to assess the medium-term aesthetic appearance and quality of the r...
What is the current status of trial NCT01640366?
This trial is currently completed. It is a NA study. The enrollment target is 200 participants. The study started on 2012-06. Estimated completion is 2014-07.
What conditions does trial NCT01640366 study?
This clinical trial studies the following conditions: Delayed Healing.
What interventions are being tested in trial NCT01640366?
The interventions under investigation include: PICO (DEVICE).
Who is sponsoring clinical trial NCT01640366?
This trial is sponsored by Smith & Nephew, which has 72 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01640366 being conducted?
This trial has 6 study locations across Illinois, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01640366's enrollment target sits among peer trials
200 506th of 2000 higher than 1,434 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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