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NCT00227084 Clinical Trial

Effect of Arista Powder on Bleeding in Reductive Mammary Surgery

Mammaplasty Clinical Trial

Official title:
Effect of Arista AH-Haemostatic Powder in Plastic Surgery. A Prospective, Consecutive Randomized Study in 30 Women Undergoing Reduction of Both Mamma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00227084
Other study ID # 1.2005.419
Secondary ID
Status Completed
Phase Phase 2
First received September 23, 2005
Last updated August 24, 2007
Start date September 2005
Est. completion date October 2006

Study information
Verified date August 2007
Source University of Oslo
Contact n/a
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research Ethics
Study type Interventional

Clinical Trial 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

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

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date October 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Arista AH hemostasis powder

Locations
Country Name City State
Norway Ulleval University Hospital Oslo

Sponsors (3)
Lead Sponsor Collaborator
University of Oslo Medafor, Ullevaal University Hospital

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary duration of surgery
Primary amount of bleeding on drain
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