Intraoperative Hyaluronic Acid Gel Injection for Improvement of Scar Quality Following Reduction Mammaplasty
- Conditions
- Cicatrix
- Registration Number
- NCT00958425
- Lead Sponsor
- Nova Scotia Health Authority
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - adequate organ function (BUN < 4.0 mmol/L; serum creatinine < 120 micromol/L; Hgb ><br> 100 g/L; WBC > 4,000/mm3 and < 12,000/mm3; platelets > 100,000/mm3)<br><br> - age 18 years or older, with a minimum life expectancy of 2 years<br><br> - current non-smoker<br><br> - American Society of Anaesthesiology score of 1 or 2<br><br> - ability to provide informed consent<br><br>Exclusion Criteria:<br><br> - previous history of breast surgery; known allergy to polyglactin, poliglecaprone, or<br> injectable hyaluronic acid gel (Restylane or Prevelle)<br><br> - history of current or recent (<2 months) immunosuppression<br><br> - documented hypersensitivity to streptococcal products<br><br> - acute or chronic skin diseases such as folliculitis or psoriasis<br><br> - history of bleeding dyscrasia or active anticoagulation (INR>2.0)<br><br> - pregnancy or active breast-feeding<br><br> - any additional surgical procedures performed in the same surgical session in the<br> same anatomical region<br><br> - personal or family history of susceptibility to keloid or hypertrophic scar<br> formation<br><br> - Fitzpatrick skin type 5 or 6.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rasch analysis-modified Objective Scar Assessment Score (OSAS) value
- Secondary Outcome Measures
Name Time Method