Status:
RECRUITING
Abdominal Scar Improvement in Microsurgical Breast Reconstruction
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Neodyne Biosciences, Inc.
Conditions:
Cicatrix
Breast Reconstruction
Eligibility:
FEMALE
18-89 years
Phase:
NA
Brief Summary
Microsurgical breast reconstruction is most commonly performed with free abdominal flaps, which leave a long transverse lower abdominal scar. Due to tension across the incision, these scars frequently...
Detailed Description
Adult (\>18 years) women who have undergone microsurgical breast reconstruction with free abdominal flap(s) approximately 1 week (5-10 days) prior to study participation will be approached by the clin...
Eligibility Criteria
Inclusion
- Female Subjects who have undergone unilateral/bilateral microsurgical breast reconstruction with free abdominal flaps within approximately 1 week (4-8 days) prior to study participation.
- Appearance of subject's incision is aesthetically similar across length of incision
- Age \>18
- Subject has the ability to read and comprehend as required by the protocol and the informed consent.
- Subject must be able to provide written informed consent prior to participation in the study.
Exclusion
- Subjects with a history of collagen vascular disease, cutis laxica, connective tissue disease, psoriasis, or lupus.
- Subjects diagnosed with scleroderma.
- Subjects with known adverse reactions to steri-strip tapes, medical tapes, or adhesives.
- Subjects with oozing, dehiscence, non-closed/healed incisions at time of first application.
- Subjects with inability to maintain adequate care of incision.
- Subjects with a weight loss of \> 100 lbs within 6 months from date of surgery.
- Subjects who currently smoke.
- Subjects taking steroid therapy (systemic or inhaled) within 2 months from date of study enrollment.
- Subject does not qualify for the study in the opinion of the investigators.
Key Trial Info
Start Date :
October 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05377723
Start Date
October 31 2022
End Date
January 31 2026
Last Update
December 18 2025
Active Locations (1)
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1
Stanford University Medical Center
Stanford, California, United States, 94305