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Intraoperative Hyaluronic Acid Gel Injection for Improvement of Scar Quality Following Reduction Mammaplasty

This study has suspended participant recruitment.
(Failure of funding)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00958425
First Posted: August 13, 2009
Last Update Posted: January 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Michael Bezuhly, Nova Scotia Health Authority
August 11, 2009
August 13, 2009
January 13, 2016
January 2014
August 2016   (Final data collection date for primary outcome measure)
Rasch analysis-modified Objective Scar Assessment Score (OSAS) value [ Time Frame: 12 months post-operatively ]
Same as current
Complete list of historical versions of study NCT00958425 on ClinicalTrials.gov Archive Site
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Intraoperative Hyaluronic Acid Gel Injection for Improvement of Scar Quality Following Reduction Mammaplasty
Intraoperative Hyaluronic Acid Gel Injection for Improvement of Scar Quality Following Reduction Mammaplasty: a Phase III Double-blinded, Single-centred, Randomized Controlled Study
The purpose of this study is to determine the efficacy of hyaluronic acid gel injections compared to saline injections in improving scar quality in patients undergoing breast reduction surgery. Hyaluronic acid has been implicated in scarless fetal healing, and the investigators therefore hypothesize that injections of hyaluronic acid gel into breast reduction incisions will improve their appearance compared to injections of saline.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cicatrix
  • Device: Hyaluronic acid gel
    Hyaluronic acid gel (20 mg/mL), 0.9 mL, intradermal over 2 cm area, once
    Other Names:
    • Prevelle
    • Restylane
    • Hyalorunan
    • Hyaluronate
  • Device: Saline
    Normal saline, 0.9 mL, intradermal over 2 cm area, once
    Other Name: Normal saline
  • Experimental: Hyaluronic acid gel
    Intervention: Device: Hyaluronic acid gel
  • Active Comparator: Saline
    Intervention: Device: Saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
40
Not Provided
August 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • adequate organ function (BUN < 4.0 mmol/L; serum creatinine < 120 micromol/L; Hgb > 100 g/L; WBC > 4,000/mm3 and < 12,000/mm3; platelets > 100,000/mm3)
  • age 18 years or older, with a minimum life expectancy of 2 years
  • current non-smoker
  • American Society of Anaesthesiology score of 1 or 2
  • ability to provide informed consent

Exclusion Criteria:

  • previous history of breast surgery; known allergy to polyglactin, poliglecaprone, or injectable hyaluronic acid gel (Restylane or Prevelle)
  • history of current or recent (<2 months) immunosuppression
  • documented hypersensitivity to streptococcal products
  • acute or chronic skin diseases such as folliculitis or psoriasis
  • history of bleeding dyscrasia or active anticoagulation (INR>2.0)
  • pregnancy or active breast-feeding
  • any additional surgical procedures performed in the same surgical session in the same anatomical region
  • personal or family history of susceptibility to keloid or hypertrophic scar formation
  • Fitzpatrick skin type 5 or 6.
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00958425
CDHA-RS/2009-252
Yes
Not Provided
Not Provided
Michael Bezuhly, Nova Scotia Health Authority
Nova Scotia Health Authority
Not Provided
Principal Investigator: Michael Bezuhly, MD MSc SM FRCSC Capital District Health Authority; Dalhousie University
Nova Scotia Health Authority
January 2016

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