NCT00227084

Effect of Arista Powder on Bleeding in Reductive Mammary Surgery

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (planned)
• Sponsor: University of Oslo · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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

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

Conditions

• Mammaplasty

Interventions

Type	Name	Description
DRUG	Arista AH hemostasis powder

Timeline

• Start date: 2005-09-01
• Completion: 2006-10-01
• First posted: 2005-09-27
• Last updated: 2007-08-27

Locations

1 site across 1 country: Norway