Effect of Arista Powder on Bleeding in Reductive Mammary Surgery

University of Oslo

Status and phase: Completed; Phase 2

Conditions: Mammaplasty

Treatments: Drug: Arista AH hemostasis powder

Study type: Interventional

Funder types: Other

Identifiers

NCT00227084

1.2005.419

Details and patient eligibility

About

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

Full 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

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)