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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Mastectomy, Postoperative Pain, Complications

Intervention / Treatment
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* Procedure: Dermamatrix to cover lateral aspect of tissue expander
* Procedure: Serratus anterior to cover lateral aspect of tissue expander


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional Method<br>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<br>* Traditional use of serratus anterior for coverage of lateral aspect of tissue expander<br>|
| Experimental: Dermamatrix Arm<br>Arm which uses Dermamatrix as the lateral expander coverage | Procedure: Dermamatrix to cover lateral aspect of tissue expander<br>* Dermamatrix used to cover lateral aspect of breast tissue expander after mastectomy<br>* Other names: Dermamatrix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain |  | perioperative up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| aesthetic outcome |  | 1 year | 
| complications (infection, hematoma, capsular contracture) |  | 1 year | 
| Patient satisfaction |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acellular dermal matrix, breast reconstruction, tissue expander, postoperative pain, complication, pain, patient satisfaction