Study Stopped
Failure of funding
Intraoperative Hyaluronic Acid Gel Injection for Improvement of Scar Quality Following Reduction Mammaplasty
1 other identifier
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2014
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2009
CompletedFirst Posted
Study publicly available on registry
August 13, 2009
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedAugust 21, 2024
January 1, 2016
Same day
August 11, 2009
August 19, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Rasch analysis-modified Objective Scar Assessment Score (OSAS) value
12 months post-operatively
Study Arms (2)
Hyaluronic acid gel
EXPERIMENTALSaline
ACTIVE COMPARATORInterventions
Hyaluronic acid gel (20 mg/mL), 0.9 mL, intradermal over 2 cm area, once
Normal saline, 0.9 mL, intradermal over 2 cm area, once
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Bezuhly, MD MSc SM FRCSC
Capital District Health Authority; Dalhousie University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2009
First Posted
August 13, 2009
Study Start
January 1, 2014
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
August 21, 2024
Record last verified: 2016-01