Effect of Arista Powder on Bleeding in Reductive Mammary Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2006-10-31

Brief Summary

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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

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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

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Mammaplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Arista AH hemostasis powder

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Principal Investigators

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Christian Askenberg, MD

Role: PRINCIPAL_INVESTIGATOR

Ullevaal University Hospital

Petter A Steen, MD,PhD

Role: STUDY_DIRECTOR

University of Oslo

Locations

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Ulleval University Hospital

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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1.2005.419

Identifier Type: -

Identifier Source: org_study_id