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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

About this trial

This is an interventional treatment trial for Cicatrix

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

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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