Effect of Arista AH-Haemostatic Powder in Plastic Surgery. A Prospective, Consecutive Randomized Study in 30 Women Undergoing Reduction of Both Mamma
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University of Oslo
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- duration of surgery
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All women for mammary hypertrophy day surgery. No exclusions in this group.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
duration of surgery
amount of bleeding on drain
Secondary Outcomes
No secondary outcomes reported