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.

Study Overview

• Status: Withdrawn
• Conditions: Cicatrix
• Intervention / Treatment: Device: Hyaluronic acid gel; Device: Saline

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Saline	Device: Saline; Normal saline, 0.9 mL, intradermal over 2 cm area, once; Other Names: Normal saline
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: Restylane; Hyaluronate; Prevelle; Hyalorunan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rasch analysis-modified Objective Scar Assessment Score (OSAS) value	12 months post-operatively

Collaborators and Investigators

• Sponsor: Nova Scotia Health Authority
• Investigators: Principal Investigator: Michael Bezuhly, MD MSc SM FRCSC, Capital District Health Authority; Dalhousie University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2014
• Primary Completion (Estimated): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: August 11, 2009
• First Submitted That Met QC Criteria: August 12, 2009
• First Posted (Estimated): August 13, 2009

Study Record Updates

• Last Update Posted (Actual): August 21, 2024
• Last Update Submitted That Met QC Criteria: August 19, 2024
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: CDHA-RS/2009-252