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NCT01430130: IMPROVE
Investigation of a Novel Mechanomodulating Polymer to Maximize the Outcomes of Scar Revision Procedures
NA trial testing embrace device in Hypertrophic in 12 participants. Completed in 1 November 2012.
1 November 2012
Quick facts
| Lead sponsor | Neodyne Biosciences, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 12 |
| Start date | 1 September 2011 |
| Primary completion | 1 November 2012 |
| Estimated completion | 1 November 2012 |
| Sites | 1 location across United States |
Drugs / interventions tested
- embrace device
Conditions studied
- Hypertrophic — all drugs for Hypertrophic →
Sponsor
Neodyne Biosciences, Inc.
Who can join
Adults 18 to 65, any sex, with Hypertrophic. 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.
-
Visual Analogue Scale (VAS)
Time frame: 6 months
Visual Analogue Scale Scar Score (VAS Scar Score) was defined and validated by Duncan et al 2006\[1\]. This scale consists of a 10cm line representing scar quality, with 0 representing normal skin and 10 indicating a poor scar. The assessor places a mark along the line to represent the appearance of the scar. This mark is translated into a score by measuring its position on the 10cm line to one de
Sponsor's own description
Neodyne has developed an investigational dressing for post-operative incision care. Neodyne is conducting this research to study whether the investigational dressing, called the Neodyne Dressing, can minimize scar formation in a simple manner.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
The embrace device significantly decreases scarring following scar revision surgery in a randomized controlled trial.
Lim AF, Weintraub J, Kaplan EN, Januszyk M, et al · · 2014 · cited 75× · PMID 24105084 · DOI 10.1097/01.prs.0000436526.64046.d0
Verify or expand the search:
- PubMed search for NCT01430130
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Neodyne Biosciences, Inc. trials
Trials by the same sponsor.
- NCT06025513 — De-tensioning Patch, in Subjects With Type 1 Diabetes and Lipohypertrophy · NA · completed
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 NCT01430130 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Neodyne Biosciences, Inc.
- Last refreshed: 21 November 2014
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/NCT01430130.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing