Use of Dermal Matrix in Breast Reconstruction
Not Applicable
Terminated
- Conditions
- Breast Cancer
- Interventions
- Procedure: standard of care tissue expander breast reconstruction surgery after mastectomyProcedure: DermaMatrix
- Registration Number
- NCT00692692
- Lead Sponsor
- Vanderbilt University
- Brief Summary
We propose to evaluate the question of whether there is a significant difference between the traditional method of serratus flap tissue expander reconstruction and the acellular matrix method.
- Detailed Description
We propose a double blinded, randomized study of 60 women comparing outcomes which will include postoperative pain, complication rates and aesthetic outcome as assessed by the patient and a plastic surgeon blinded to the method of reconstruction.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 36
Inclusion Criteria
- All women who are candidates for breast reconstruction using tissue expanders after mastectomy
Exclusion Criteria
- Other forms of breast reconstruction after mastectomy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Standard of care standard of care tissue expander breast reconstruction surgery after mastectomy standard of care using skin/soft tissue and muscle coverage of tissue expander for breast reconstruction after mastectomy without acellular dermal matrix DermaMatrix DermaMatrix experimental group with DermaMatrix acellular dermis over tissue expanders in addition to skin/soft tissue and muscle to allow for more natural appearing breast and prevention of complications
- Primary Outcome Measures
Name Time Method Post Surgical Infection 4 weeks Number of participants with post surgical infection
Patient Satisfaction With the Procedure one year from time of operation
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States