Breast Cancer
Conditions
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.
Interventions
PROCEDUREDermaMatrix
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
PROCEDUREstandard 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
Sponsors
Vanderbilt University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* All women who are candidates for breast reconstruction using tissue expanders after mastectomy
Exclusion criteria
* Other forms of breast reconstruction after mastectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post Surgical Infection | 4 weeks | Number of participants with post surgical infection |
| Patient Satisfaction With the Procedure | one year from time of operation | — |
Countries
United States
Participant flow
Recruitment details
recruited from the clinic
Participants by arm
| Arm | Count |
|---|---|
| Both Arms | 36 |
| Total | 36 |
Baseline characteristics
| Characteristic | Both Arms |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| Region of Enrollment United States | 36 participants |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 16 |
| other Total, other adverse events | 6 / 20 | 2 / 16 |
| serious Total, serious adverse events | 0 / 20 | 0 / 16 |
Outcome results
Primary
Patient Satisfaction With the Procedure
Time frame: one year from time of operation
Population: study was terminated and 1 year follow up was not done
Primary
Post Surgical Infection
Number of participants with post surgical infection
Time frame: 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DermaMatrix | Post Surgical Infection | 6 Participants |
| Standard of Care | Post Surgical Infection | 2 Participants |