Effect of Arista Powder on Bleeding in Reductive Mammary Surgery

• Sponsor: University of Oslo (Other)
• Overall Status: Completed
• CT.gov ID: NCT00227084
• Collaborator: Ullevaal University Hospital (Other), Medafor (Other)
• Enrollment: 30
• Location: 1
• Duration (Months): 13
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• 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: Sep 1, 2005
• Actual Study Completion Date: Oct 1, 2006

Outcome Measures

Primary Outcome Measures

1. duration of surgery []

2. amount of bleeding on drain []

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00227084
• Other Study ID Numbers: 1.2005.419
• First Posted: Sep 27, 2005
• Last Update Posted: Aug 27, 2007
• Last Verified: Aug 1, 2007

• Keywords provided by , ,: Mammary glands; hemostasis; Mammaplasty
• Additional relevant MeSH terms: Hemostatics

Study Results

No Results Posted as of Aug 27, 2007