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OpenTrials
Completed

NCT Number: NCT00227084

Effect of Arista Powder on Bleeding in Reductive Mammary Surgery

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

Completed

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Key information

Conditions

Mammaplasty

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Ulleval University Hospital

Oslo, N-0407 Oslo, Norway

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Arista AH hemostasis powder

Drug

Primary outcomes

  1. duration of surgery

  2. amount of bleeding on drain

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Collaborators

  • Medafor
  • Ullevaal University Hospital

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2006
First posted
Sep 27, 2005
Registry last updated
Aug 27, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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