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PICO Breast Reduction Clinical Study Looking at Incision Healing Complications

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ClinicalTrials.gov Identifier: NCT01640366
Recruitment Status : Completed
First Posted : July 13, 2012
Last Update Posted : January 11, 2016
Sponsor:
Information provided by (Responsible Party):
Smith & Nephew Wound Management Inc

Study Description
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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.

Condition or disease Intervention/treatment Phase
Delayed Healing Device: PICO Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : June 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : July 2014

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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    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 :
  1. 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 ]
  2. 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 ]
    The Patient and Observer Scar Assessment Scale (POSAS) and The Visual Analogue Scale (VAS)

  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Responsible Party: Smith & Nephew Wound Management Inc
ClinicalTrials.gov Identifier: NCT01640366     History of Changes
Other Study ID Numbers: CE/US/11/01/PIC
First Posted: July 13, 2012    Key Record Dates
Last Update Posted: January 11, 2016
Last Verified: January 2016

Keywords provided by Smith & Nephew Wound Management Inc:
surgical incision
reduction mammoplasty
healing complications
negative pressure wound therapy

Additional relevant MeSH terms:
Surgical Wound
Wounds and Injuries