Intraoperative Hyaluronic Acid Gel Injection for Improvem... | NCT00958425

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

NCT00958425

Sponsor

Nova Scotia Health Authority

Status

Withdrawn

Last Update Posted

Aug 21, 2024Actual

Enrollment

0Actual

Phase

Phase 3

Conditions

Cicatrix

Interventions

Hyaluronic acid gel
Saline

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Failure of funding

Expanded Access Info

Start Date

Jan 1, 2014Estimated

Primary Completion Date

Jan 1, 2014Estimated

Completion Date

Jan 1, 2014Actual

First Submitted Date

Aug 11, 2009

First Submission Date that Met QC Criteria

Aug 12, 2009

First Posted Date

Aug 13, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 19, 2024

Last Update Posted Date

Aug 21, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hyaluronic acid gel	Experimental		Device: Hyaluronic acid gel
Saline	Active Comparator		Device: Saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hyaluronic acid gel	Device	Hyaluronic acid gel (20 mg/mL), 0.9 mL, intradermal over 2 cm area, once	Hyaluronic acid gel

Measure	Description	Time Frame
Rasch analysis-modified Objective Scar Assessment Score (OSAS) value		12 months post-operatively

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Bezuhly, MD MSc SM FRCSC	Capital District Health Authority; Dalhousie University	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002921	Cicatrix

Ancestor Terms

ID	Term
D005355	Fibrosis
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided