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Effect of Arista Powder on Bleeding in Reductive Mammary Surgery

This study has been completed.
Sponsor:
Collaborators:
Ullevaal University Hospital
Medafor
Information provided by:
University of Oslo
ClinicalTrials.gov Identifier:
NCT00227084
First received: September 23, 2005
Last updated: August 24, 2007
Last verified: August 2007
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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:

U.S. FDA Resources

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

Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00227084     History of Changes
Other Study ID Numbers: 1.2005.419
Study First Received: September 23, 2005
Last Updated: August 24, 2007
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by University of Oslo:
Mammary glands
hemostasis
Mammaplasty

Additional relevant MeSH terms:
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013