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Clinical Trials/NCT00616824
NCT00616824
Terminated
Phase 4

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

Vanderbilt University Medical Center1 site in 1 country36 target enrollmentSeptember 2007

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Mastectomy
Sponsor
Vanderbilt University Medical Center
Enrollment
36
Locations
1
Primary Endpoint
postoperative pain
Status
Terminated
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2007
End Date
March 2010
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

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
  • 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

Outcomes

Primary Outcomes

postoperative pain

Time Frame: perioperative up to 1 year

Secondary Outcomes

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

Study Sites (1)

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