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

This study is enrolling participants by invitation only.

Sponsor:

Information provided by:

Vanderbilt University

ClinicalTrials.gov Identifier:

NCT00616824

First received: February 5, 2008

Last updated: February 14, 2008

Last verified: February 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

February 5, 2008

Last Updated Date

February 14, 2008

Start Date ^ICMJE

September 2007

Estimated Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

postoperative pain [ Time Frame: perioperative up to 1 year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00616824 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

aesthetic outcome [ Time Frame: 1 year ] [ Designated as safety issue: No ]
complications (infection, hematoma, capsular contracture) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Patient satisfaction [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Mastectomy
Postoperative Pain
Complications

Intervention ^ICMJE

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

Other Name: Dermamatrix
Procedure: Serratus anterior to cover lateral aspect of tissue expander
Traditional use of serratus anterior for coverage of lateral aspect of tissue expander

Study Arm (s)

Active Comparator: Traditional Method
Arm which uses the Serratus Anterior muscle mobilization for lateral coverage of the tissue expander

Intervention: Procedure: Serratus anterior to cover lateral aspect of tissue expander
Experimental: Dermamatrix Arm
Arm which uses Dermamatrix as the lateral expander coverage

Intervention: Procedure: Dermamatrix to cover lateral aspect of tissue expander

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2008

Estimated Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00616824

Other Study ID Numbers ^ICMJE

070415, 070415

Has Data Monitoring Committee

Yes

Responsible Party

J. Jason Wendel, M.D., Vanderbilt University Department of Plastic Surgery

Study Sponsor ^ICMJE

Vanderbilt University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jason J. Wendel, M.D.

Vanderbilt University

Information Provided By

Vanderbilt University

Verification Date

February 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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