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

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. Identifier: NCT00958425
Recruitment Status : Suspended (Failure of funding)
First Posted : August 13, 2009
Last Update Posted : January 13, 2016
Information provided by (Responsible Party):
Michael Bezuhly, Nova Scotia Health Authority

Brief Summary:
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 or disease Intervention/treatment Phase
Cicatrix Device: Hyaluronic acid gel Device: Saline Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : January 2014
Estimated Primary Completion Date : August 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Rasch analysis-modified Objective Scar Assessment Score (OSAS) value [ Time Frame: 12 months post-operatively ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

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 identifier (NCT number): NCT00958425

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

Responsible Party: Michael Bezuhly, Assistant Professor, Department of Surgery, Nova Scotia Health Authority Identifier: NCT00958425     History of Changes
Other Study ID Numbers: CDHA-RS/2009-252
First Posted: August 13, 2009    Key Record Dates
Last Update Posted: January 13, 2016
Last Verified: January 2016

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