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Effect of Arista Powder on Bleeding in Reductive Mammary Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00227084
First Posted: September 27, 2005
Last Update Posted: August 27, 2007
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.
Collaborators:
Ullevaal University Hospital
Medafor
Information provided by:
University of Oslo
  Purpose
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 Intervention Phase
Mammaplasty Drug: Arista AH hemostasis powder Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Oslo:

Primary Outcome Measures:
  • duration of surgery
  • amount of bleeding on drain

Estimated Enrollment: 30
Study Start Date: September 2005
Study Completion Date: October 2006
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

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • All women for mammary hypertrophy day surgery. No exclusions in this group.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00227084


Locations
Norway
Ulleval University Hospital
Oslo, Norway, N-0407 Oslo
Sponsors and Collaborators
University of Oslo
Ullevaal University Hospital
Medafor
Investigators
Principal Investigator: Christian Askenberg, MD Ullevaal University Hospital
Study Director: Petter A Steen, MD,PhD University of Oslo
  More Information

ClinicalTrials.gov Identifier: NCT00227084     History of Changes
Other Study ID Numbers: 1.2005.419
First Submitted: September 23, 2005
First Posted: September 27, 2005
Last Update Posted: August 27, 2007
Last Verified: August 2007

Keywords provided by University of Oslo:
Mammary glands
hemostasis
Mammaplasty

Additional relevant MeSH terms:
Hemostatics
Coagulants