At a glance
ClinicalIndex Comparison RecordN/ACompleted· 200 enrolled
Drug / intervention
PICOdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Randomized, Intra-patient, Comparative, Open, Multi-centre Study to Evaluate the Efficacy of a Single-Use NPWT System on the Prevention of Incision Healing Complications in Patients Undergoing Reduction Mammoplasty
In Brief
A clinical study evaluating PICO for Delayed Healing. Completed, enrolled 200 participants across 6 sites in 4 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDelayed Healing
CountriesFrance, Netherlands, South Africa, United States
Collaborators--
Timeline
N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2012
First PostedJul 2012
Primary CompletionApr 2014
Study CompletionJul 2014
TodayJul 2026
First PostedJul 13, 2012
Enrollment StartJun 1, 2012
Primary CompletionApr 1, 2014
Study CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.0 years ago
Interventions
PICOdevice
Single-use Negative Pressure Wound Therapy System