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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
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

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

    First Posted
    August 11, 2009
    Last Updated
    January 12, 2016
    Sponsor
    Nova Scotia Health Authority
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    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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