Improving abdominal scars after breast reconstruction
Abdominal Scar Improvement in Microsurgical Breast Reconstruction
This study tests if using the Neodyne embrace device can make abdominal scars look better after breast reconstruction surgery in women who have just had the procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | Female |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Stanford, California) |
| Trial ID | NCT05377723 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of the Neodyne embrace device in improving the appearance of abdominal scars following microsurgical breast reconstruction using free abdominal flaps. Adult women who have undergone this procedure within a week will be invited to participate, provided their incisions appear aesthetically similar. Participants will have one side of their incision treated with the Neodyne device while the other side will receive standard care, allowing for a direct comparison of outcomes. Evaluations of scar appearance will occur at 8 and 12 weeks post-procedure.
Who should consider this trial
Good fit: Ideal candidates are women over 18 who have recently undergone microsurgical breast reconstruction with free abdominal flaps.
Not a fit: Patients with certain connective tissue diseases or those with complications at the incision site may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the aesthetic outcomes of abdominal scars for women undergoing breast reconstruction.
How similar studies have performed: This is a novel approach, as it is the first randomized controlled trial investigating the Neodyne device's effect on scar appearance in this specific context.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Stanford, California
- Stanford University Medical Center — Stanford, California, United States (Recruiting)
Study contacts
- Principal investigator: Arash Momeni, MD — Stanford University
- Study coordinator: Shannon Meyer
- Email: smeyer27@stanford.edu
- Phone: 650-721-1807
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.