PICO Breast Reduction Clinical Study Looking at Incision Healing Complications

Completed · Not applicable

Conditions studied: Delayed Healing

In brief

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.

Key facts

Study ID

NCT01640366

Run by

Smith & Nephew, Inc.

People needed

200

Starts

2012-06-01

Expected to finish

2014-07-01

Last updated by the study team

2020-02-28

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female patient's ≥ 18 years old
• The patient is able to understand the trial and is willing to consent to the trial
• Patient has undergone an elective surgical procedure for bilateral reduction mammoplasty
• Patients postsurgical incisions are of similar length

You may not qualify if…

• Pregnant or lactating females
• Patients on steroids or other immune modulators known to impact healing which may affect scar appearance
• Patients with tattoos in the area of the incisions
• Patients with skin conditions (Cutis laxa etc.) that would result in poor healing or widened scars
• Patients with a known significant history of scar problems i.e. hypertrophic scaring or keloids
• Patients who in the opinion of the investigator may not complete the study for any reason
• Patients with a known history of poor compliance with medical treatment
• Patients who have participated in this trial previously and who were withdrawn
• Patients with known allergies to product components (silicone adhesives and polyurethane films (direct contact with wound), acrylic adhesives (direct contact with skin), polyethylene fabrics and super-absorbent powders (polyacrylates) (within the dressing)
• Incisions that are actively bleeding
• Exposure of blood vessels, organs, bone or tendon at the base of the reference wound
• Incisions > 12 inches (30cm) max linear dimension

Where it is running

• Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States
• Montefiore — The Bronx, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• CHU de Nantes Hôtel Dieu — Nantes, France
• Academisch Ziekenhuis Maastricht (AZM) — Maastricht, Netherlands
• University of Cape Town — Cape Town, South Africa

Full record on ClinicalTrials.gov

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