NCT01399099: REFINE

Scar Prevention and the Clinical Effectiveness of a Novel Mechanomodulating Polymer

Completed NA Results posted Last updated 14 November 2024

What this trial tests

NA trial testing embrace device in Hypertrophic in 67 participants. Completed in 1 March 2013.

Timeline

1 June 2011

Primary endpoint
1 September 2012

1 March 2013

Quick facts

Lead sponsor	Neodyne Biosciences, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	67
Start date	1 June 2011
Primary completion	1 September 2012
Estimated completion	1 March 2013
Sites	13 locations 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: 12 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
• 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):

1. A randomized controlled trial of the embrace advanced scar therapy device to reduce incisional scar formation.
   Longaker MT, Rohrich RJ, Greenberg L, Furnas H, et al · · 2014 · cited 76× · PMID 24804638 · DOI 10.1097/prs.0000000000000417