Intraoperative Hyaluronic Acid Gel Injection for Improvement of Scar Quality Following Reduction Mammaplasty
Primary Purpose
Cicatrix
Status
Suspended
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Hyaluronic acid gel
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Cicatrix
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Hyaluronic acid gel
Saline
Arm Description
Outcomes
Primary Outcome Measures
Rasch analysis-modified Objective Scar Assessment Score (OSAS) value
Secondary Outcome Measures
Full Information
NCT ID
NCT00958425
First Posted
August 11, 2009
Last Updated
January 12, 2016
Sponsor
Nova Scotia Health Authority
1. Study Identification
Unique Protocol Identification Number
NCT00958425
Brief Title
Intraoperative Hyaluronic Acid Gel Injection for Improvement of Scar Quality Following Reduction Mammaplasty
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Suspended
Why Stopped
Failure of funding
Study Start Date
January 2014 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nova Scotia Health Authority
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cicatrix
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hyaluronic acid gel
Arm Type
Experimental
Arm Title
Saline
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Hyaluronic acid gel
Other Intervention Name(s)
Prevelle, Restylane, Hyalorunan, Hyaluronate
Intervention Description
Hyaluronic acid gel (20 mg/mL), 0.9 mL, intradermal over 2 cm area, once
Intervention Type
Device
Intervention Name(s)
Saline
Other Intervention Name(s)
Normal saline
Intervention Description
Normal saline, 0.9 mL, intradermal over 2 cm area, once
Primary Outcome Measure Information:
Title
Rasch analysis-modified Objective Scar Assessment Score (OSAS) value
Time Frame
12 months post-operatively
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Bezuhly, MD MSc SM FRCSC
Organizational Affiliation
Capital District Health Authority; Dalhousie University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Intraoperative Hyaluronic Acid Gel Injection for Improvement of Scar Quality Following Reduction Mammaplasty
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