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

Tracking Information
First Submitted Date ICMJE	August 11, 2009
First Posted Date ICMJE	August 13, 2009
Last Update Posted Date	January 13, 2016
Study Start Date ICMJE	January 2014
Estimated Primary Completion Date	August 2016 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: August 12, 2009)	Rasch analysis-modified Objective Scar Assessment Score (OSAS) value [ Time Frame: 12 months post-operatively ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00958425 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Intraoperative Hyaluronic Acid Gel Injection for Improvement of Scar Quality Following Reduction Mammaplasty
Official Title ICMJE	Intraoperative Hyaluronic Acid Gel Injection for Improvement of Scar Quality Following Reduction Mammaplasty: a Phase III Double-blinded, Single-centred, Randomized Controlled Study
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 Provided
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Cicatrix
Intervention ICMJE	Device: Hyaluronic acid gel Hyaluronic acid gel (20 mg/mL), 0.9 mL, intradermal over 2 cm area, once Other Names: Prevelle Restylane Hyalorunan Hyaluronate; Device: Saline Normal saline, 0.9 mL, intradermal over 2 cm area, once Other Name: Normal saline
Study Arms	Experimental: Hyaluronic acid gel Intervention: Device: Hyaluronic acid gel; Active Comparator: Saline Intervention: Device: Saline
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Suspended
Estimated Enrollment ICMJE; (submitted: August 12, 2009)	40
Original Estimated Enrollment ICMJE	Same as current
Study Completion Date	Not Provided
Estimated Primary Completion Date	August 2016 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: Female
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Not Provided
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00958425
Other Study ID Numbers ICMJE	CDHA-RS/2009-252
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Michael Bezuhly, Nova Scotia Health Authority
Study Sponsor ICMJE	Nova Scotia Health Authority
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Michael Bezuhly, MD MSc SM FRCSC Capital District Health Authority; Dalhousie University
PRS Account	Nova Scotia Health Authority
Verification Date	January 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP