Breast Reconstruction Clinical Trial
Official title:
Abdominal Scar Improvement in Microsurgical Breast Reconstruction
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | October 31, 2024 |
Est. primary completion date | October 30, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 89 Years |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Stanford University Medical Center | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Scar Assessment | The primary endpoint is the difference between the assessments of the scar appearance for the treated as compared to the control incision sites. Incisions will be evaluated by an objective independent expert panel at six months post surgery. The panel will review close-up photographic records, taken at the 6 month study endpoint, of the control incision site and the treated incision site. The subject will complete the Scar Q questionnaire and both the investigator and the subject will complete the Patient and Observer Scar Assessment Scale (POSAS). It is expected that the scar from the incision area covered by Neodyne Dressing will be minimized when compared to the scar from the untreated incision area. | 6 months |
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