Implant Capsular Contracture
Conditions
Keywords
capsular contracture, capsulectomy, mesna, Capsular contracture after breast implant placement
Brief summary
The purpose of this study is to make available an agent,Mesna, which can assist the surgeon during the procedure of capsulectomy.
Detailed description
Mesna is a FDA approved drug for the treatment of respiratory diseases and is used a protective agent against drugs in oncology patients. It has also been used in Gynecologic surgery and ENT. Mesna is a drug that breaks down adhesions between tissue layers.
Interventions
DRUGMesna
B. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed
Sponsors
Vanderbilt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* All females undergoing capsulectomy
Exclusion criteria
* All pregnant women and nursing mothers will be exclued
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare Number of Patients With Capsular Contracture in Mesna Group vs Standard of Care | one year |
Secondary
| Measure | Time frame |
|---|---|
| Compare Number of Patients With Adverse Events in the Mesna Group vs the Standard of Care | one year |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Standard procedure or capsulectomy for removal of capsule; no mesna
Mesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed | 9 |
| Mesna The use of Mesna of removal of capsule for capsular contracture.
Mesna: A. Mesna will be used to aid in the removal of the capsule when capsulectomy is performed | 11 |
| Total | 20 |
Baseline characteristics
| Characteristic | Standard | Mesna | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 11 Participants | 20 Participants |
| Region of Enrollment United States | 9 participants | 11 participants | 20 participants |
| Sex: Female, Male Female | 9 Participants | 11 Participants | 20 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 9 | 0 / 11 |
| serious Total, serious adverse events | 0 / 9 | 0 / 11 |
Outcome results
Primary
Compare Number of Patients With Capsular Contracture in Mesna Group vs Standard of Care
Time frame: one year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard | Compare Number of Patients With Capsular Contracture in Mesna Group vs Standard of Care | 2 participants |
| Mesna | Compare Number of Patients With Capsular Contracture in Mesna Group vs Standard of Care | 4 participants |
Secondary
Compare Number of Patients With Adverse Events in the Mesna Group vs the Standard of Care
Time frame: one year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard | Compare Number of Patients With Adverse Events in the Mesna Group vs the Standard of Care | 0 participants |
| Mesna | Compare Number of Patients With Adverse Events in the Mesna Group vs the Standard of Care | 0 participants |