The Use of an Acellular Dermal Matrix in a Two-Staged Breast Reconstruction
Stopped early · Phase 4
Conditions studied: Mastectomy, Postoperative Pain, Complications
In brief
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.
Key facts
- Study ID
- NCT00616824
- Run by
- Vanderbilt University Medical Center
- People needed
- 36
- Starts
- 2007-09-01
- Expected to finish
- 2010-03-01
- Last updated by the study team
- 2017-04-04
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.