ACTIVE_NOT_RECRUITING

Abdominal Scar Improvement in Microsurgical Breast Reconstruction

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Conditions

CicatrixBreast Reconstruction

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Abdominal Scar Improvement in Microsurgical Breast Reconstruction

Quick Facts

Study Start:2022-10-31
Study Completion:2026-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05377723

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 89 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Appearance of subject's incision is aesthetically similar across length of incision
  3. 3. Age \>18
  4. 4. Subject has the ability to read and comprehend as required by the protocol and the informed consent.
  5. 5. Subject must be able to provide written informed consent prior to participation in the study.
  1. 1. Subjects with a history of collagen vascular disease, cutis laxica, connective tissue disease, psoriasis, or lupus.
  2. 2. Subjects diagnosed with scleroderma.
  3. 3. Subjects with known adverse reactions to steri-strip tapes, medical tapes, or adhesives.
  4. 4. Subjects with oozing, dehiscence, non-closed/healed incisions at time of first application.
  5. 5. Subjects with inability to maintain adequate care of incision.
  6. 6. Subjects with a weight loss of \> 100 lbs within 6 months from date of surgery.
  7. 7. Subjects who currently smoke.
  8. 8. Subjects taking steroid therapy (systemic or inhaled) within 2 months from date of study enrollment.
  9. 9. Subject does not qualify for the study in the opinion of the investigators.

Contacts and Locations

Principal Investigator

Arash Momeni, MD
PRINCIPAL_INVESTIGATOR
Stanford University

Study Locations (Sites)

Stanford University Medical Center
Stanford, California, 94305
United States

Collaborators and Investigators

Sponsor: Stanford University

  • Arash Momeni, MD, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-31
Study Completion Date2026-04

Study Record Updates

Study Start Date2022-10-31
Study Completion Date2026-04

Terms related to this study

Additional Relevant MeSH Terms

  • Cicatrix
  • Breast Reconstruction