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

Cicatrix Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00958425
• Other study ID #: CDHA-RS/2009-252
• Status: Suspended
• Phase: Phase 3
• First received: August 11, 2009
• Last updated: January 12, 2016
• Start date: January 2014

Study information

• Verified date: January 2016
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 40
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cicatrix

Intervention

Device:
• Hyaluronic acid gel
Hyaluronic acid gel (20 mg/mL), 0.9 mL, intradermal over 2 cm area, once
• Saline
Normal saline, 0.9 mL, intradermal over 2 cm area, once

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nova Scotia Health Authority

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rasch analysis-modified Objective Scar Assessment Score (OSAS) value		12 months post-operatively	No