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NCT05377723
Abdominal Scar Improvement in Microsurgical Breast Reconstruction
NA trial testing Neodyne Device in Cicatrix in 30 participants. Participants enrolled and being followed up; not accepting new ones.
30 January 2026
Quick facts
| Lead sponsor | Stanford University |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 30 |
| Start date | 31 October 2022 |
| Primary completion | 30 January 2026 |
| Estimated completion | 1 July 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Neodyne Device
Conditions studied
- Cicatrix — all drugs for Cicatrix →
- Breast Reconstruction — all drugs for Breast Reconstruction →
Sponsor
Stanford University
Who can join
Adults 18 to 89, female only, with Cicatrix or Breast Reconstruction. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Scar Assessment
Time frame: 6 months
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 subj
Sponsor's own 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05377723
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Cicatrix
Currently open trials in the same condition.
- NCT06122090 — Treatment of Hypopigmented Scars With Bimatoprost · Phase 2 · recruiting
Other Stanford University trials
Trials by the same sponsor.
- NCT05945147 — Ketamine and Midazolam Infusions for CRPS: Feasibility Study · Phase 2 · withdrawn
- NCT04225949 — Patients Understanding of PROM Graphs · NA · withdrawn
- NCT06273098 — School-Based Bladder Health Intervention · NA · withdrawn
- NCT04652635 — Management of Nailbed Injuries · NA · withdrawn
- NCT05443503 — Stanford Spine Keeper - Managing Your Low Back Pain · NA · suspended
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05377723 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Stanford University
- Last refreshed: 4 May 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05377723.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing