PICO Breast Reduction Clinical Study Looking at Incision Healing Complications - Full Text View

Purpose

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.

Condition	Intervention	Phase
Delayed Healing	Device: PICO	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: Breast Reconstruction

U.S. FDA Resources

Further study details as provided by Smith & Nephew Wound Management Inc:

Primary Outcome Measures:

Difference in incision healing complications up to and 21 days post-operatively between postsurgical incisions treated with PICO compared with standard care [ Time Frame: 21 days ] [ Designated as safety issue: No ]
To assess the difference in incision healing complications up to and 21 days post-operatively between postsurgical incisions treated with PICO compared with standard care

Secondary Outcome Measures:

To assess the number and type of any postsurgical incision healing complication occurring up to and 21 days post-operatively between incisions treated with PICO compared with standard care dressings [ Time Frame: 21 days ] [ Designated as safety issue: No ]
To assess the aesthetic appearance (cosmesis) and scar quality at 42 and 90 days between postsurgical incisions treated with PICO compared with standard care dressings using POSAS and VAS [ Time Frame: 90 days ] [ Designated as safety issue: No ]
The Patient and Observer Scar Assessment Scale (POSAS) and The Visual Analogue Scale (VAS)
Difference in the amount of skin, nipple and areola necrosis occurring up to and 21 days post-operatively between incisions treated with PICO compared with standard care dressings [ Time Frame: 21 days ] [ Designated as safety issue: No ]
Difference in the number of hematoma's occurring up to and 21 days post-operatively between incisions treated with PICO compared with standard care dressings [ Time Frame: 21 days ] [ Designated as safety issue: No ]
Difference in the amount dehiscence occurring up to and 21 days post-operatively between incisions treated with PICO compared with standard care dressings [ Time Frame: 21 days ] [ Designated as safety issue: No ]
Difference in the number of infections occurring up to and 21 days post-operatively between incisions treated with PICO compared with standard care dressings [ Time Frame: 21 days ] [ Designated as safety issue: No ]
Difference in the number of seroma's occurring up to and 21 days post-operatively between incisions treated with PICO compared with standard care dressings. [ Time Frame: 21 days ] [ Designated as safety issue: No ]


Enrollment:	200
Study Start Date:	June 2012
Estimated Study Completion Date:	June 2014
Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: PICO negative pressure	Device: PICO Single-use negative pressure wound therapy system Other Name: Disposible NPWT
No Intervention: Standard of care dressing arm

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


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01640366

Locations


United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
United States, New York
Montefiore
Bronx, New York, United States, 10461
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Netherlands
Academisch Ziekenhuis Maastricht (AZM)
Maastricht, Netherlands, 6202
South Africa
University of Cape Town
Cape Town, South Africa

Sponsors and Collaborators

Smith & Nephew Wound Management Inc

Investigators


Principal Investigator:	Robert D Galiano, MD	Northwestern University Feinberg School of Medicine

More Information

No publications provided


Responsible Party:	Smith & Nephew Wound Management Inc
ClinicalTrials.gov Identifier:	NCT01640366 History of Changes
Other Study ID Numbers:	CE/US/11/01/PIC
Study First Received:	July 3, 2012
Last Updated:	January 2, 2014
Health Authority:	United States: Institutional Review Board United States: Food and Drug Administration South Africa: Department of Health South Africa: Human Research Ethics Committee Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Smith & Nephew Wound Management Inc:


surgical incision reduction mammoplasty healing complications negative pressure wound therapy

ClinicalTrials.gov processed this record on February 27, 2015