Abdominal Scar Improvement in Microsurgical Breast Reconstruction (NCT05377723) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Abdominal Scar Improvement in Microsurgical Breast Reconstruction
United States30 participantsStarted 2022-10-31
Plain-language 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 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.
Who can participate
Age range18 Years – 89 Years
SexFEMALE
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Inclusion criteria
✓. 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 criteria
✕. 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.