Intraoperative Hyaluronic Acid Gel Injection for Improvement of Scar Quality Following Reduction Mammaplasty
NCT ID: NCT00958425
Last Updated: 2024-08-21
Study Results
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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WITHDRAWN
PHASE3
INTERVENTIONAL
2014-01-01
2014-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Hyaluronic acid gel
Hyaluronic acid gel
Hyaluronic acid gel (20 mg/mL), 0.9 mL, intradermal over 2 cm area, once
Saline
Saline
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
Saline
Normal saline, 0.9 mL, intradermal over 2 cm area, once
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
Yes
Sponsors
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Nova Scotia Health Authority
OTHER
Responsible Party
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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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