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

Phase 3

Withdrawn

• Conditions: Cicatrix
• Interventions: Device: Hyaluronic acid gel; Device: Saline

• Registration Number: NCT00958425
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-08-11
• Study First Submitted QC: 2009-08-12
• Study First Posted: 2009-08-13
• Study Start: 2014-01-01
• Primary Completion: 2014-01-01
• Study Completion: 2014-01-01
• Status Verified: 2016-01
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyaluronic acid gel	Hyaluronic acid gel	-
Saline	Saline	-

Primary Outcome Measures

Name	Time	Method
Rasch analysis-modified Objective Scar Assessment Score (OSAS) value	12 months post-operatively