Clinical trial NCT01640366: PICO Breast Reduction Clinical Study Looking at Incision Healing Complications
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delayed Healing
Keywords: surgical incision
reduction mammoplasty
healing complications
negative pressure wound therapy
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2012-07-13
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Participants Experiencing Incision Healing Complications up to Day 21 Postoperatively
timeFrame: 21 days postoperatively
Secondary outcomes:
measure: Number of Participants Experiencing Postsurgical Incision Healing Complications (Dehiscence) Occurring up to Day 21 Postoperatively
timeFrame: 21 days postoperatively
measure: Number of Participants Experiencing Postsurgical Incision Healing Complications (Infection) Occurring up to Day 21 Postoperatively
timeFrame: 21 days postoperatively
measure: Number of Participants Experiencing Postsurgical Incision Healing Complications (Delayed Healing) Occurring Within 7 Days Postoperatively
timeFrame: Within 7 days postoperatively
measure: Number of Participants Experiencing Postsurgical Incision Healing Complications (Delayed Healing) Occurring Within 10 Days Postoperatively
timeFrame: Within 10 days postoperatively
measure: Aesthetic Appearance (Cosmesis) and Scar Quality at 90 Days Postoperatively
timeFrame: 90 days postoperatively
measure: Number of Skin, Nipple and Areola Necrosis Occurring up to and 21 Days Postoperatively
timeFrame: 21 days postoperatively
measure: Number of Hematoma's Occurring up to and 21 Days Postoperatively
timeFrame: 21 days postoperatively
measure: Number of Wounds Showing 100% Closure Occurring up to and 21 Days Postoperatively
timeFrame: 21 days postoperatively
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Bronx
country: United States
facility: Montefiore
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Nantes
country: France
facility: CHU de Nantes Hôtel Dieu
city: Maastricht
country: Netherlands
facility: Academisch Ziekenhuis Maastricht (AZM)
city: Cape Town
country: South Africa
facility: University of Cape Town
Study officials:
affiliation: Northwestern University Feinberg School of Medicine
name: Robert D Galiano, MD
role: PRINCIPAL_INVESTIGATOR
References: