Status:
WITHDRAWN
Intraoperative Hyaluronic Acid Gel Injection for Improvement of Scar Quality Following Reduction Mammaplasty
Lead Sponsor:
Nova Scotia Health Authority
Conditions:
Cicatrix
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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. Hyalur...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00958425
Start Date
January 1 2014
End Date
January 1 2014
Last Update
August 21 2024
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