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

This study is not yet open for participant recruitment.
Verified June 2011 by Capital District Health Authority, Canada
Sponsor:
Information provided by:
Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT00958425
First received: August 11, 2009
Last updated: June 27, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Cicatrix
 Device: Hyaluronic acid gel
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intraoperative Hyaluronic Acid Gel Injection for Improvement of Scar Quality Following Reduction Mammaplasty: a Phase III Double-blinded, Single-centred, Randomized Controlled Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • Rasch analysis-modified Objective Scar Assessment Score (OSAS) value [ Time Frame: 12 months post-operatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hyaluronic acid gel 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00958425

Contacts
Contact: Michael Bezuhly, MD MSc SM 902 830-4566 mbezuhly@dal.ca

Sponsors and Collaborators
Capital District Health Authority, Canada
Investigators
Principal Investigator: Richard Bendor-Samuel, MD FRCSC Capital District Health Authority; Dalhousie University
  More Information

No publications provided

Responsible Party: Dr. Michael Bezuhly, Capital District Health Authority
ClinicalTrials.gov Identifier: NCT00958425     History of Changes
Other Study ID Numbers: CDHA-RS/2009-252
Study First Received: August 11, 2009
Last Updated: June 27, 2011
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes
Hyaluronic Acid
 Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013