Abdominal Scar Improvement in Microsurgical Breast Reconstruction

Recruiting

I'm Interested

Trial 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
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 Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Arash Momeni, MD
650-723-6189