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NCT05377723 · ClinicalTrials.gov registry record · NA

Abdominal Scar Improvement in Microsurgical Breast Reconstruction

A NA study of Breast Reconstruction and Cicatrix, sponsored by Stanford University.

Active
Registry status
NA
Development phase
30
Enrollment target
1
Study location

NCT05377723: Active NA study of Breast Reconstruction and Cicatrix, sponsored by Stanford University.

NCT05377723 is a NA study of Breast Reconstruction and Cicatrix that is active but no longer recruiting, run by Stanford University. The registered enrollment target is 30 participants, below the 392-participant average among 18 other Breast Reconstruction trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05377723, a NA study of Breast Reconstruction and Cicatrix, is active but no longer recruiting, sponsored by Stanford University.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
30 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

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 t

Interventions

  • DEVICE Neodyne Device

Study Locations (1)

California

  • Stanford University Medical Center - Stanford

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2022-10-31
Est. Completion 2026-04
Phase NA
Stanford University

1,744 total trials

What the registry record for NCT05377723 still lists

NCT05377723 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 392-participant average among 18 other Breast Reconstruction trials with a reported enrollment target (92% lower).

The record links to 2 conditions, with Breast Reconstruction appearing as the primary indexed condition, and to 1 intervention - of which Neodyne Device is the first listed.

NCT05377723 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT05377723 about?

NCT05377723 is a clinical study titled "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 appear...

What is the current status of trial NCT05377723?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2022-10-31. Estimated completion is 2026-04.

What conditions does trial NCT05377723 study?

This clinical trial studies the following conditions: Breast Reconstruction, Cicatrix.

What interventions are being tested in trial NCT05377723?

The interventions under investigation include: Neodyne Device (DEVICE).

Who is sponsoring clinical trial NCT05377723?

This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05377723 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Breast Reconstruction

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05377723's enrollment target sits among peer trials

30 19th of 18 the lowest of 18 other Breast Reconstruction trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Breast Reconstruction trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05377723, the US trial registry maintained by the National Library of Medicine. NCT05377723 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.