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

Nova Scotia Health Authority (NSHA)

Status and phase

Withdrawn

Phase 3

Conditions

Cicatrix

Treatments

Device: Saline

Device: Hyaluronic acid gel

Study type

Interventional

Funder types

Other

Identifiers

NCT00958425

CDHA-RS/2009-252

Details and patient eligibility

About

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.

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.