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

July 3, 2012
January 2, 2014
June 2012
December 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01640366 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
PICO Breast Reduction Clinical Study Looking at Incision Healing Complications
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Delayed Healing
Device: PICO
Single-use negative pressure wound therapy system
Other Name: Disposible NPWT
  • Experimental: PICO negative pressure
    Intervention: Device: PICO
  • No Intervention: Standard of care dressing arm
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
June 2014
December 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands,   United States,   South Africa
 
NCT01640366
CE/US/11/01/PIC
No
Smith & Nephew Wound Management Inc
Smith & Nephew Wound Management Inc
Not Provided
Principal Investigator: Robert D Galiano, MD Northwestern University Feinberg School of Medicine
Smith & Nephew Wound Management Inc
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP