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

Sponsor

Vanderbilt University Medical Center (Other)

Overall Status

Terminated

CT.gov ID

NCT00616824

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mastectomy Postoperative Pain Complications	Procedure: Dermamatrix to cover lateral aspect of tissue expander Procedure: Serratus anterior to cover lateral aspect of tissue expander	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2007

Actual Primary Completion Date :

Mar 1, 2010

Actual Study Completion Date :

Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Traditional Method Arm which uses the Serratus Anterior muscle mobilization for lateral coverage of the tissue expander	Procedure: Serratus anterior to cover lateral aspect of tissue expander Traditional use of serratus anterior for coverage of lateral aspect of tissue expander
Experimental: Dermamatrix Arm Arm which uses Dermamatrix as the lateral expander coverage	Procedure: Dermamatrix to cover lateral aspect of tissue expander Dermamatrix used to cover lateral aspect of breast tissue expander after mastectomy Other Names: Dermamatrix

Arm

Intervention/Treatment

Active Comparator: Traditional Method

Arm which uses the Serratus Anterior muscle mobilization for lateral coverage of the tissue expander

Procedure: Serratus anterior to cover lateral aspect of tissue expander

Traditional use of serratus anterior for coverage of lateral aspect of tissue expander

Experimental: Dermamatrix Arm

Arm which uses Dermamatrix as the lateral expander coverage

Procedure: Dermamatrix to cover lateral aspect of tissue expander

Dermamatrix used to cover lateral aspect of breast tissue expander after mastectomy

Other Names:

Dermamatrix

Outcome Measures

Primary Outcome Measures

postoperative pain [perioperative up to 1 year]

Secondary Outcome Measures

aesthetic outcome [1 year]
complications (infection, hematoma, capsular contracture) [1 year]
Patient satisfaction [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.