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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

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

Condition or disease Intervention/treatment Phase
Mammaplasty Drug: Arista AH hemostasis powder Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Arista AH-Haemostatic Powder in Plastic Surgery. A Prospective, Consecutive Randomized Study in 30 Women Undergoing Reduction of Both Mamma
Study Start Date : September 2005
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. duration of surgery
  2. amount of bleeding on drain

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All women for mammary hypertrophy day surgery. No exclusions in this group.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00227084

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Ulleval University Hospital
Oslo, Norway, N-0407 Oslo
Sponsors and Collaborators
University of Oslo
Ullevaal University Hospital
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Principal Investigator: Christian Askenberg, MD Ullevaal University Hospital
Study Director: Petter A Steen, MD,PhD University of Oslo
Layout table for additonal information Identifier: NCT00227084    
Other Study ID Numbers: 1.2005.419
First Posted: September 27, 2005    Key Record Dates
Last Update Posted: August 27, 2007
Last Verified: August 2007
Keywords provided by University of Oslo:
Mammary glands
Additional relevant MeSH terms:
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