Trials / Terminated
TerminatedNCT00692692
Use of Dermal Matrix in Breast Reconstruction
The Use of An Acellular Dermal Matrix Sling in a Two-stage Breast REconstruciton After Mastectomy: A Double-blinded Randomized Trial
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Vanderbilt University · Academic / Other
- Sex
- Female
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | 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 |
| PROCEDURE | 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 |
Timeline
- Start date
- 2007-06-01
- Primary completion
- 2010-12-01
- Completion
- 2010-12-01
- First posted
- 2008-06-06
- Last updated
- 2018-03-19
- Results posted
- 2013-10-11
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00692692. Inclusion in this directory is not an endorsement.