Effect of Arista Powder on Bleeding in Reductive Mammary Surgery

University of Oslo30 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mammaplasty

Interventions

Arista AH hemostasis powderDRUG

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

Inclusion Criteria: * All women for mammary hypertrophy day surgery. No exclusions in this group.

Locations (1)

Ulleval University Hospital

Oslo, Norway

Outcomes

Primary Outcomes

duration of surgery

amount of bleeding on drain

Data from ClinicalTrials.gov

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