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Tissue Expander for Capsular Contracture

N/A
Waitlist Available
Led By Nathalie Johnson, MD
Research Sponsored by Legacy Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

The main purpose of this research study is to determine if the use of Trental and Vitamin E will decrease the incidence and severity of contractures (shrinking and or hardening of tissue surrounding the implant) associated with breast implant reconstruction following radiation treatment. Another goal is to find out the impact that Trental and Vitamin E have on implant loss or need for surgical intervention in the setting of chest wall radiation after reconstruction. In addition, the investigators want to evaluate the patient's sense of well being and quality of life.

Eligible Conditions
  • Capsular Contracture

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Measure number and grade of contractures occurring after implant reconstruction and radiation treatment in subjects receiving Trental and vitamin E combination compared to placebo using the Bakers grade assessment
Secondary outcome measures
Number of implant revisions or loss of implants due to post radiation changes in subject receiving Trental and vitamin E compared to placebo through patient interview with research staff

Side effects data

From 2017 Phase 2 trial • 31 Patients • NCT01508221
10%
Fatigue
10%
Anxiety
6%
Nausea
6%
Anorexia
6%
Cough
3%
Weight loss
3%
Lower back pain
3%
Non-cardiac chest pain
3%
Diaphoresis
3%
Right leg weakness
3%
Arrhythmia
3%
Constipation
3%
Gait disturbance
3%
Generalized weakness
3%
Sleep disturbance
3%
Depression
3%
Orthostatic dizziness
3%
Pain in shoulder
3%
Vomiting
3%
Leg swelling
3%
Back pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trental + Vitamin E

Trial Design

2Treatment groups
Experimental Treatment
Group I: Tissue ExpanderExperimental Treatment1 Intervention
Trental and Vitamin E for 6 months
Group II: Permanent ImplantExperimental Treatment1 Intervention
Trental and Vitamin E for 6 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pentoxifylline
FDA approved

Find a Location

Who is running the clinical trial?

Legacy Health SystemLead Sponsor
35 Previous Clinical Trials
3,651 Total Patients Enrolled
Nathalie Johnson, MDPrincipal InvestigatorLegacy Health System
3 Previous Clinical Trials
65 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Prevention of Capsular Contracture Using Trental and Vitamin E
Nathalie Johnson 2009. "Prevention of Capsular Contracture Using Trental and Vitamin E". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01082003.
All > Prevention
~2 spots leftby Apr 2025
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