- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00227084
Effect of Arista Powder on Bleeding in Reductive Mammary Surgery
Effect of Arista AH-Haemostatic Powder in Plastic Surgery. A Prospective, Consecutive Randomized Study in 30 Women Undergoing Reduction of Both Mamma
Study Overview
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 Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
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Oslo, Norway, N-0407 Oslo
- Ullevål University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All women for mammary hypertrophy day surgery. No exclusions in this group.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
duration of surgery
|
amount of bleeding on drain
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christian Askenberg, MD, Ullevaal University Hospital
- Study Director: Petter A Steen, MD,PhD, University of Oslo
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1.2005.419
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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