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

Primary Purpose

Mastectomy, Postoperative Pain, Complications

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dermamatrix to cover lateral aspect of tissue expander
Serratus anterior to cover lateral aspect of tissue expander
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mastectomy focused on measuring Acellular dermal matrix, breast reconstruction, tissue expander, postoperative pain, complication, pain, patient satisfaction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

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

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Traditional Method

Dermamatrix Arm

Arm Description

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

Arm which uses Dermamatrix as the lateral expander coverage

Outcomes

Primary Outcome Measures

postoperative pain

Secondary Outcome Measures

aesthetic outcome
complications (infection, hematoma, capsular contracture)
Patient satisfaction

Full Information

First Posted
February 5, 2008
Last Updated
March 30, 2017
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00616824
Brief Title
The Use of an Acellular Dermal Matrix in a Two-Staged Breast Reconstruction
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 Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Study Start Date
September 2007 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mastectomy, Postoperative Pain, Complications
Keywords
Acellular dermal matrix, breast reconstruction, tissue expander, postoperative pain, complication, pain, patient satisfaction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traditional Method
Arm Type
Active Comparator
Arm Description
Arm which uses the Serratus Anterior muscle mobilization for lateral coverage of the tissue expander
Arm Title
Dermamatrix Arm
Arm Type
Experimental
Arm Description
Arm which uses Dermamatrix as the lateral expander coverage
Intervention Type
Procedure
Intervention Name(s)
Dermamatrix to cover lateral aspect of tissue expander
Other Intervention Name(s)
Dermamatrix
Intervention Description
Dermamatrix used to cover lateral aspect of breast tissue expander after mastectomy
Intervention Type
Procedure
Intervention Name(s)
Serratus anterior to cover lateral aspect of tissue expander
Intervention Description
Traditional use of serratus anterior for coverage of lateral aspect of tissue expander
Primary Outcome Measure Information:
Title
postoperative pain
Time Frame
perioperative up to 1 year
Secondary Outcome Measure Information:
Title
aesthetic outcome
Time Frame
1 year
Title
complications (infection, hematoma, capsular contracture)
Time Frame
1 year
Title
Patient satisfaction
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason J. Wendel, M.D.
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-2345
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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