Abdominal Scar Improvement in Microsurgical Breast Reconstruction

Trial ID or NCT#

NCT05377723

Status

recruiting iconRECRUITING

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

Eligibility Criteria

Ages Eligible for Study: 18 Years to 89 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 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. 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.
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Investigator(s)

Arash Momeni, MD, FACS
Arash Momeni, MD, FACS
Plastic and reconstructive surgeon, Breast reconstructive surgeon, Plastic surgeon
Associate Professor of Surgery (Plastic and Reconstructive Surgery)

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Contact

Arash Momeni, MD
650-723-6189

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View on ClinicalTrials.gov