Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00227084
Other study ID # 1.2005.419
Secondary ID
Status Completed
Phase Phase 2
First received September 23, 2005
Last updated August 24, 2007
Start date September 2005
Est. completion date October 2006

Study information

Verified date August 2007
Source University of Oslo
Contact n/a
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research Ethics
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date October 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Arista AH hemostasis powder


Locations

Country Name City State
Norway Ulleval University Hospital Oslo

Sponsors (3)

Lead Sponsor Collaborator
University of Oslo Medafor, Ullevaal University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary duration of surgery
Primary amount of bleeding on drain
See also
  Status Clinical Trial Phase
Completed NCT04329819 - Satisfaction and QUality of Life After Breast REconstruction
Completed NCT04919317 - Combination Dexamethasone and Bupivacaine Pain Control in Reduction Mammaplasty Phase 2
Completed NCT03016663 - Volumetric Study of Fat Resorption After Breast Lipofilling N/A
Not yet recruiting NCT03240900 - Electrical Stimulation for Improving Postoperative Breast Sensation N/A
Recruiting NCT05171179 - The Use of Pecs Blocks in Combination With Exparel in Breast Reconstruction Surgery Phase 3
Terminated NCT00432328 - Juvista (Avotermin) in Breast Reduction Surgery Scars Phase 2
Active, not recruiting NCT04715802 - Options on the Breast Reconstruction Timing and Method After Removal of Polyacrylamide Hydrogel
Recruiting NCT03488888 - PEC Block II in Mammoplasty Surgeries N/A
Completed NCT03744273 - Capsule Biopsy in Acellular Dermal Matrix-based Prosthetic Breast Reconstruction: a Prospective Pilot Study N/A
Enrolling by invitation NCT03069885 - iNPWT in Immediate Breast Reconstruction N/A
Withdrawn NCT00310882 - Involvement of Endogenous Digitalis-like Compounds in Breast Cancer N/A
Recruiting NCT04891510 - A Comparative Analysis of REVOLVE, LipoGrafter, and Viality in Autologous Fat Grafting During Breast Surgery N/A
Recruiting NCT03118024 - Perioperative Management of DIEP Flaps N/A
Completed NCT04854525 - Breast Reconstruction in Previously Irradiated Breast
Completed NCT04783818 - Adjuvant Radiotherapy's Effect on One and Two Stages Prosthetic Breast Reconstruction and on Autologous Reconstruction
Not yet recruiting NCT06420323 - NovoX®Cup as Primary Dressing After Breast Reduction
Not yet recruiting NCT02791672 - Perioperative Care of Breast Reconstruction With Latissimus Dorsi Flap and Tissue Expander: Early Discharge Protocol in a Day Surgery Setting N/A
Completed NCT04273464 - Breast Reconstruction With Autologous Tissue: Microsurgery or Fat Grafting? N/A
Completed NCT00616135 - Study of Autologous Fat Enhanced w/ Regenerative Cells Transplanted to Reconstruct Breast Deformities After Lumpectomy Phase 4
Completed NCT00466765 - Breast Reconstruction and Augmentation With Brava Enhanced Autologous Fat Micro Grafting N/A