PICO Breast Reduction Clinical Study Looking at Incision Healing Complications

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew Wound Management Inc
ClinicalTrials.gov Identifier:
NCT01640366
First received: July 3, 2012
Last updated: January 2, 2014
Last verified: January 2014
  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:


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 July 22, 2014