NCT05377723

Abdominal Scar Improvement in Microsurgical Breast Reconstruction

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: Female
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Adult (\>18 years) women who have undergone microsurgical breast reconstruction with free abdominal flap(s) approximately 1 week (5-10 days) prior to study participation will be approached by the clinical research team during their first postoperative clinic visit; the protocol asks for the device to be applied at this point. Investigators will only invite those subjects to participate whose incisions, at the 1 week postoperative visit, appear to be uniformly aesthetically similar across the length of the incision. Informed consent for randomization and study participation will be obtained. After eligible patients have provided informed consent, the side of the abdomen to be treated with the Neodyne Device will be randomly selected by opening a sealed randomization envelope. The selected side will be treated with the Neodyne Device through the full study. The Neodyne Device will be applied to a portion of the abdominal incision by the health care provider at 1 week (4-8 days) after the procedure. The other portion of the abdominal incision will serve as the control and will be treated per the investigator's standard of care. Subjects will return to the Investigator's office for a total of 8 weeks for application and removal of the Neodyne Dressing. At the 8th week visit subjects and investigators will complete an evaluation of the incision/scar. Subjects will return to the Investigator's office at 12 weeks from the date of the procedure for another evaluation of the incision/scar. The primary study endpoint will be evaluated at 6 months from the date of the procedure. Subjects will also be offered the opportunity to provide additional photographic evaluations at 12 months after surgery in conjunction with a standard clinic visit.

Conditions

• Cicatrix
• Breast Reconstruction

Interventions

Type	Name	Description
DEVICE	Neodyne Device	See Arm Description: Neodyne Device

Timeline

• Start date: 2022-10-31
• Primary completion: 2026-03-01
• Completion: 2026-04-01
• First posted: 2022-05-17
• Last updated: 2026-01-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study