NCT00616824

The Use of an Acellular Dermal Matrix in a Two-Staged Breast Reconstruction

The Use of an Acellular Dermal Matrix in a Two-Staged Breast Reconstruction The Use of an Acellular Dermal Matrix in a Two-Staged Breast Reconstruction After Mastectomy: A Double-Blinded, Randomized Trial

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study intends to compare postoperative outcomes of a tissue expander placement following a mastectomy with two different operative techniques. This study will be randomized and double blinded comparing the traditional placement of the tissue expander under an inferolateral serratus muscle flap to a new technique which uses an acellular dermal matrix as an inferolateral sling, instead of the muscle flap. The study we are proposing will evaluate the question of whether there is a difference between the traditional method of serratus flap and the new technique of using an acellular matrix with tissue expander placement. This will be a double blinded randomized study of thirty women in each group comparing outcomes which will include postoperative pain, complications (wound infection, hematoma, capsular contracture, etc), and patient satisfaction with the procedure.

Conditions

• Mastectomy
• Postoperative Pain
• Complications

Interventions

Type	Name	Description
PROCEDURE	Dermamatrix to cover lateral aspect of tissue expander	Dermamatrix used to cover lateral aspect of breast tissue expander after mastectomy
PROCEDURE	Serratus anterior to cover lateral aspect of tissue expander	Traditional use of serratus anterior for coverage of lateral aspect of tissue expander

Timeline

• Start date: 2007-09-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2008-02-15
• Last updated: 2017-04-04

Locations

1 site across 1 country: United States