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Abdominal Scar Improvement in Microsurgical Breast Reconstruction
Recruiting
I'm InterestedTrial ID: NCT05377723
Purpose
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 widen and hypertrophy. Hence, modalities that can reduce this tendency,
thus, improving scar appearance are desirable. Here, we wish to investigate the impact of the
Neodyne embrace device on postoperative abdominal scar appearance. The proposed study is
novel in that it is the first RCT investigating the effect of the embrace device on scar
appearance in the context of microsurgical breast reconstruction.
Official Title
Abdominal Scar Improvement in Microsurgical Breast Reconstruction
Stanford Investigator(s)
Arash Momeni, MD, FACS
Associate Professor of Surgery (Plastic and Reconstructive Surgery)
Eligibility
Inclusion Criteria:
1. 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.
2. Appearance of subject's incision is aesthetically similar across length of incision
3. Age >18
4. Subject has the ability to read and comprehend as required by the protocol and the
informed consent.
5. Subject must be able to provide written informed consent prior to participation in the
study.
Exclusion Criteria:
1. Subjects with a history of collagen vascular disease, cutis laxica, connective tissue
disease, psoriasis, or lupus.
2. Subjects diagnosed with scleroderma.
3. Subjects with known adverse reactions to steri-strip tapes, medical tapes, or
adhesives.
4. Subjects with oozing, dehiscence, non-closed/healed incisions at time of first
application.
5. Subjects with inability to maintain adequate care of incision.
6. Subjects with a weight loss of > 100 lbs within 6 months from date of surgery.
7. Subjects who currently smoke.
8. Subjects taking steroid therapy (systemic or inhaled) within 2 months from date of
study enrollment.
9. Subject does not qualify for the study in the opinion of the investigators.
Intervention(s):
device: Neodyne Device
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Arash Momeni, MD
650-723-6189