NCT01640366

PICO Breast Reduction Clinical Study Looking at Incision Healing Complications

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Smith & Nephew, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The aim of the present study is to assess the efficacy and cost-effectiveness of the Single-Use Negative Pressure Wound Therapy (NPWT) system (PICO) with regard to the reduction of postsurgical incision healing complications during the immediate postoperative treatment phase, and to assess the medium-term aesthetic appearance and quality of the resultant scar, in patients undergoing reduction mammoplasty, compared to standard care.

Conditions

• Delayed Healing

Interventions

Type	Name	Description
DEVICE	PICO	Single-use Negative Pressure Wound Therapy System

Timeline

• Start date: 2012-06-01
• Primary completion: 2014-04-01
• Completion: 2014-07-01
• First posted: 2012-07-13
• Last updated: 2020-02-28
• Results posted: 2020-02-28

Locations

6 sites across 4 countries: United States, France, Netherlands, South Africa

Regulatory

• FDA-regulated device study