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A Study of a Novel Silicone Dressing to Minimize Scar Formation (REFINE)

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ClinicalTrials.gov Identifier: NCT01399099
Recruitment Status : Completed
First Posted : July 21, 2011
Results First Posted : December 25, 2014
Last Update Posted : December 25, 2014
Sponsor:
Collaborator:
U.S. Army Medical Research and Development Command
Information provided by (Responsible Party):
Neodyne Biosciences, Inc.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hypertrophic
Intervention Device: embrace device
Enrollment 67
Recruitment Details Procedures were performed by 12 surgeons at 12 surgery centers between June 2011 and May of 2012.
Pre-assignment Details  
Arm/Group Title All Study Participants
Hide Arm/Group Description Half of the abdomnioplasty incision was treated with the embrace device. Half of the abdomnioplasty incision was treated according to the investigator's standard of care. Participant served as his own control.
Period Title: Overall Study
Started 67
6 Months 47
Completed 36
Not Completed 31
Reason Not Completed
Lost to Follow-up             11
Physician Decision             1
Protocol Violation             1
Skin Irritation             13
Infection             1
Miscellaneous             4
Arm/Group Title All Study Participants
Hide Arm/Group Description Half of the abdomnioplasty incision was treated with the embrace device. Half of the abdomnioplasty incision was treated according to the investigator's standard of care. Participant served as his own control.
Overall Number of Baseline Participants 67
Hide Baseline Analysis Population Description
After meeting all eligibility criteria, 67 patients were enrolled.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants
<=18 years
0
   0.0%
Between 18 and 65 years
66
  98.5%
>=65 years
1
   1.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants
Female
65
  97.0%
Male
2
   3.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants
American Indian or Alaska Native
0
   0.0%
Asian
6
   9.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
5
   7.5%
White
47
  70.1%
More than one race
0
   0.0%
Unknown or Not Reported
9
  13.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 67 participants
Hispanic or Latino
21
  31.3%
Not Hispanic or Latino
46
  68.7%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 67 participants
67
1.Primary Outcome
Title Visual Analogue Scale (VAS)
Hide Description

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 decimal place. The independent panel used this to scale the primary outcome.

[1] Duncan J, Bond J, Mason T, Ludlow A, Cridland P, O'Kane S and Ferguson M. Visual Analogue Scale Scoring and Ranking: A Suitable and Sensitive Method for Assessing Scar Quality? Plast. Reconstr. Surg. 118: 909, 2006.

Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol, all eligible patients who did not exit the study prematurely.
Arm/Group Title Treated Side Control Side
Hide Arm/Group Description:
Half of the abdomnioplasty incision was treated with the embrace device.
Half of the abdomnioplasty incision was treated according to the Investigator's standard of care. Participant served as his/her own control.
Overall Number of Participants Analyzed 36 36
Mean (Standard Error)
Unit of Measure: Units on a scale
2.90  (0.18) 3.30  (0.20)
2.Secondary Outcome
Title Subject and Investigator Satisfaction With the Aesthetic Results
Hide Description [Not Specified]
Time Frame Up to 12 months
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Ease of Use
Hide Description [Not Specified]
Time Frame Up to 12 months
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Comfort Level Related to Study Device Application, Wear and Removal
Hide Description [Not Specified]
Time Frame Up to 12 weeks
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Comparison of Scar Smoothness of Treated Side as Compared to the Control Side
Hide Description [Not Specified]
Time Frame Up to 12 months
Outcome Measure Data Not Reported
Time Frame 12 Months
Adverse Event Reporting Description Adverse Events were reported via phone call or in person at weekly site visits for Neodyne dressing applications. Data was collected by investigators on Adverse Event Clinical Report Forms for each participant. After initial 12 weeks of application visits, data was collected at 6 month and 12 month (optional) intervals.
 
Arm/Group Title All Study Participants
Hide Arm/Group Description Half of the abdomnioplasty incision was treated with the embrace device. Half of the abdomnioplasty incision was treated according to the investigator's standard of care. Participant served as his own control.
All-Cause Mortality
All Study Participants
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
All Study Participants
Affected / at Risk (%) # Events
Total   0/67 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
All Study Participants
Affected / at Risk (%) # Events
Total   40/67 (59.70%)    
Skin and subcutaneous tissue disorders   
Erythema   7/67 (10.45%)  11
Infection   8/67 (11.94%)  8
Maceration   5/67 (7.46%)  8
Rash   6/67 (8.96%)  6
Skin Irritation   24/67 (35.82%)  29
Indicates events were collected by systematic assessment
  • The Neodyne Dressing is referred to as the embrace device.
  • Grant/Funding source: Armed Forces Institute of Regenerative Medicine is funded by US Army Medical Research and Materiel Command (our collaborator) http://www.afirm.mil/
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kristin Prosak
Organization: Neodyne Biosciences
Phone: 650-543-7129 ext 126
EMail: kprosak@neodynebio.com
Layout table for additonal information
Responsible Party: Neodyne Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT01399099    
Other Study ID Numbers: CA003
00016580 ( Other Grant/Funding Number: Armed Forces Institute of Regenerative Medicine )
First Submitted: June 27, 2011
First Posted: July 21, 2011
Results First Submitted: December 17, 2014
Results First Posted: December 25, 2014
Last Update Posted: December 25, 2014