Effect of Arista Powder on Bleeding in Reductive Mammary Surgery

Status Completed

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

Clinical Trial 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 ;

Study Design

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

Related Conditions & MeSH terms

Mammaplasty

Clinical Trial Details

NCT number	NCT00227084
Study type	Interventional
Source	University of Oslo
Contact
Status	Completed
Phase	Phase 2
Start date	September 2005
Completion date	October 2006

View Details

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Withdrawn	`NCT00310882` - Involvement of Endogenous Digitalis-like Compounds in Breast Cancer	N/A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