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

NCT ID: NCT00958425

Last Updated: 2024-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-01

Study Completion Date

2014-01-01

Brief Summary

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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

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Conditions

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Cicatrix

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Hyaluronic acid gel

Group Type EXPERIMENTAL

Hyaluronic acid gel

Intervention Type DEVICE

Hyaluronic acid gel (20 mg/mL), 0.9 mL, intradermal over 2 cm area, once

Saline

Group Type ACTIVE_COMPARATOR

Saline

Intervention Type DEVICE

Normal saline, 0.9 mL, intradermal over 2 cm area, once

Interventions

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Hyaluronic acid gel

Hyaluronic acid gel (20 mg/mL), 0.9 mL, intradermal over 2 cm area, once

Intervention Type DEVICE

Saline

Normal saline, 0.9 mL, intradermal over 2 cm area, once

Intervention Type DEVICE

Other Intervention Names

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Prevelle Restylane Hyalorunan Hyaluronate Normal saline

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Nova Scotia Health Authority

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Bezuhly, MD MSc SM FRCSC

Role: PRINCIPAL_INVESTIGATOR

Capital District Health Authority; Dalhousie University

Other Identifiers

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CDHA-RS/2009-252

Identifier Type: -

Identifier Source: org_study_id

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