NCT00227084

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 27, 2005

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

August 27, 2007

Status Verified

August 1, 2007

First QC Date

September 23, 2005

Last Update Submit

August 24, 2007

Conditions

Mammaplasty

Keywords

Mammary glandshemostasisMammaplasty

Outcome Measures

Primary Outcomes (2)

  • duration of surgery

  • amount of bleeding on drain

Interventions

Arista AH hemostasis powderDRUG

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ulleval University Hospital

Oslo, N-0407 Oslo, Norway

Location

Study Officials

  • Christian Askenberg, MD

    Ullevaal University Hospital

    PRINCIPAL INVESTIGATOR

  • Petter A Steen, MD,PhD

    University of Oslo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 23, 2005

First Posted

September 27, 2005

Study Start

September 1, 2005

Study Completion

October 1, 2006

Last Updated

August 27, 2007

Record last verified: 2007-08

Locations

NO(1)