Effect of Arista Powder on Bleeding in Reductive Mammary Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00227084
Recruitment Status : Completed
First Posted : September 27, 2005
Last Update Posted : August 27, 2007
Ullevaal University Hospital
Information provided by:
University of Oslo

September 23, 2005
September 27, 2005
August 27, 2007
September 2005
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  • duration of surgery
  • amount of bleeding on drain
Same as current
Complete list of historical versions of study NCT00227084 on Archive Site
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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
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

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

Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Drug: Arista AH hemostasis powder
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
October 2006
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Inclusion Criteria:

  • All women for mammary hypertrophy day surgery. No exclusions in this group.
Sexes Eligible for Study: Female
Child, Adult, Senior
Contact information is only displayed when the study is recruiting subjects
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University of Oslo
  • Ullevaal University Hospital
  • Medafor
Principal Investigator: Christian Askenberg, MD Ullevaal University Hospital
Study Director: Petter A Steen, MD,PhD University of Oslo
University of Oslo
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP