Effect of Arista Powder on Bleeding in Reductive Mammary Surgery
- Conditions
- Mammaplasty
- Registration Number
- NCT00227084
- Lead Sponsor
- University of Oslo
- Brief Summary
To evaluate whether Arista AH which contains microporous polysaccharides used as a powder applied to the wound area during mammary surgery reduces the amount of bleeding and the duration of surgery. Both mammae are operated on in the same procedure, and one side without Arista serves as control side
- Detailed Description
During the operation,before the first incision a randomization envelope is opened. Always starts on the same side, with or without Arista according to the envelope. After surgery, vacuum drains are placed and the amount of drained material and hgb content is measured 24 hours later by nursing staff blinded to what side had Arista.Patients scores postoperative pain with VAS score bilaterally.
Three months postoperatively the patients are checked by a physician blinded for what side had Arista
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 30
- All women for mammary hypertrophy day surgery. No exclusions in this group.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method duration of surgery amount of bleeding on drain
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ulleval University Hospital
🇳🇴Oslo, Norway