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

Phase 4

Terminated

• Conditions: Postoperative Pain; Mastectomy; Complications
• Interventions: Procedure: Serratus anterior to cover lateral aspect of tissue expander; Procedure: Dermamatrix to cover lateral aspect of tissue expander

• Registration Number: NCT00616824
• Lead Sponsor: Vanderbilt University Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-02-05
• Study First Submitted QC: 2008-02-14
• Study First Posted: 2008-02-15
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-30
• Last Update Posted: 2017-04-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 36

Inclusion Criteria

• Patients presenting to Dr. Wendel's clinic who are older than 17 years of age undergoing a mastectomy and wish to have breast reconstruction with a tissue expander or those who have previously undergone a mastectomy and are now seeking reconstruction will be solicited for the study.

Exclusion Criteria

• Preoperative radiation therapy
• Autoimmune disease
• Fever
• Uncontrolled diabetes mellitus
• Inability to comprehend or cooperate with postoperative instructions
• Local or systemic infection
• Have any allergies to the excipient ingredients found in the matrix
• Pregnancy
• Low vascularity of the surrounding tissue
• Mechanical trauma
• Poor nutrition
• Poor general medical condition

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional Method	Serratus anterior to cover lateral aspect of tissue expander	Arm which uses the Serratus Anterior muscle mobilization for lateral coverage of the tissue expander
Dermamatrix Arm	Dermamatrix to cover lateral aspect of tissue expander	Arm which uses Dermamatrix as the lateral expander coverage

Primary Outcome Measures

Name	Time	Method
postoperative pain	perioperative up to 1 year

Secondary Outcome Measures

Name	Time	Method
complications (infection, hematoma, capsular contracture)	1 year
Patient satisfaction	1 year
aesthetic outcome	1 year

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States