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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:
Information provided by (Responsible Party):
Michael Bezuhly, Nova Scotia Health Authority
ClinicalTrials.gov Identifier:
NCT00958425
First received: August 11, 2009
Last updated: January 12, 2016
Last verified: January 2016
  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
Device: Saline
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:


Further study details as provided by Nova Scotia Health Authority:

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 2014
Estimated Primary Completion Date: August 2016 (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
Active Comparator: Saline Device: Saline
Normal saline, 0.9 mL, intradermal over 2 cm area, once
Other Name: Normal saline

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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: NCT00958425

Sponsors and Collaborators
Nova Scotia Health Authority
Investigators
Principal Investigator: Michael Bezuhly, MD MSc SM FRCSC Capital District Health Authority; Dalhousie University
  More Information

Responsible Party: Michael Bezuhly, Assistant Professor, Department of Surgery, Nova Scotia 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: January 12, 2016
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents

ClinicalTrials.gov processed this record on December 05, 2016