Complications, Mastectomy, Postoperative Pain
Conditions
Keywords
Acellular dermal matrix, breast reconstruction, tissue expander, postoperative pain, complication, pain, patient satisfaction
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.
Interventions
PROCEDUREDermamatrix to cover lateral aspect of tissue expander
Dermamatrix used to cover lateral aspect of breast tissue expander after mastectomy
PROCEDURESerratus anterior to cover lateral aspect of tissue expander
Traditional use of serratus anterior for coverage of lateral aspect of tissue expander
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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 * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| postoperative pain | perioperative up to 1 year |
Secondary
| Measure | Time frame |
|---|---|
| aesthetic outcome | 1 year |
| complications (infection, hematoma, capsular contracture) | 1 year |
| Patient satisfaction | 1 year |
Countries
United States
Outcome results
None listed