Abdominal Scar Improvement in Microsurgical Breast Reconstruction

NCT05377723 | Active Not Recruiting FDA Device

• 2 other identifiers: IRB-59506NCI-2023-03670
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cicatrix; Breast Reconstruction

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Neodyne Device

EXPERIMENTAL

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 (Arm Title: Control) 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.

Device: Neodyne Device

Control

OTHER

See above

Device: Neodyne Device

Interventions

Neodyne Device DEVICE

See Arm Description: Neodyne Device

Control; Neodyne Device

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Subjects with inability to maintain adequate care of incision.
• Subjects with a weight loss of \> 100 lbs within 6 months from date of surgery.
• Subjects who currently smoke.
• Subjects taking steroid therapy (systemic or inhaled) within 2 months from date of study enrollment.
• Subject does not qualify for the study in the opinion of the investigators.

Sponsors & Collaborators

• Stanford University: lead
• Neodyne Biosciences, Inc.: collaborator

Study Sites (1)

Stanford University Medical Center

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Arash Momeni, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: May 17, 2022
• Study Start: October 31, 2022
• Primary Completion: January 30, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)