Study Stopped
higher rate of post-operative infection in the Dermal Matrix arm of the study
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
1 other identifier
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable breast-cancer
Started Jun 2007
Typical duration for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 4, 2008
CompletedFirst Posted
Study publicly available on registry
June 6, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedResults Posted
Study results publicly available
October 11, 2013
CompletedMarch 19, 2018
March 1, 2018
3.5 years
June 4, 2008
August 3, 2013
March 13, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Patient Satisfaction With the Procedure
one year from time of operation
Post Surgical Infection
Number of participants with post surgical infection
4 weeks
Study Arms (2)
DermaMatrix
EXPERIMENTALexperimental 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
Standard of care
ACTIVE COMPARATORstandard of care using skin/soft tissue and muscle coverage of tissue expander for breast reconstruction after mastectomy without acellular dermal matrix
Interventions
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
standard of care using skin/soft tissue and muscle coverage of tissue expander for breast reconstruction after mastectomy without acellular dermal matrix
Eligibility Criteria
You may qualify if:
- All women who are candidates for breast reconstruction using tissue expanders after mastectomy
You may not qualify if:
- Other forms of breast reconstruction after mastectomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Unable to contact PI after he left Vanderbilt. Results were entered with available data.
Results Point of Contact
- Title
- Jason Wendel, MD
- Organization
- Vanderbilt University Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Jason Wendel, MD
Vanderbilt University Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2008
First Posted
June 6, 2008
Study Start
June 1, 2007
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
March 19, 2018
Results First Posted
October 11, 2013
Record last verified: 2018-03