Trial Outcomes & Findings for Investigation of a Novel Silicone Dressing to Maximize the Outcomes of Scar Revision Procedures (IMPROVE) (NCT NCT01430130)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

6 months

Results posted on

2014-11-28

Participant Flow

All procedures were performed at a single outpatient surgery clinic between September of 2011 and May of 2012.

Participant milestones

Participant milestones
Measure	All Study Participants Half of the revised incision was treated with the embrace device. Half of the revised incision was treated according to the Investigator's standard of care. Participant served as his/her own control.
Overall Study STARTED	12
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	All Study Participants Half of the revised incision was treated with the embrace device. Half of the revised incision was treated according to the Investigator's standard of care. Participant served as his/her own control.
Overall Study Lost to Follow-up	1
Overall Study Infection on Control Side of Incision	1

Baseline Characteristics

Investigation of a Novel Silicone Dressing to Maximize the Outcomes of Scar Revision Procedures (IMPROVE)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=12 Participants Half of the revised incision was treated with the embrace device. Half of the revised incision was treated according to the Investigator's standard of care. Participant served as his/her own control.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Per protocol, all eligible patients who did not exit the study prematurely.

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.

Outcome measures

Outcome measures
Measure	Treated Side n=10 Participants Half of the revised incision was treated with the embrace device.	Control Side n=10 Participants Half of the revised incision was treated according to the investigator's standard of care. Participant served as his own control.
Visual Analogue Scale (VAS)	3.78 Units on a scale Standard Error 0.35	5.58 Units on a scale Standard Error 0.39

SECONDARY outcome

Timeframe: Up to 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 weeks

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 months

Outcome measures

Outcome data not reported

Adverse Events

Treated Side

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Control Side

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treated Side n=12 participants at risk Half of the revised incision was treated with the embrace device.	Control Side n=12 participants at risk Half of the revised incision was treated according to the investigator's standard of care. Participant served as his own control.
Skin and subcutaneous tissue disorders Redness	16.7% 2/12 • Number of events 3 • 12 months 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.	16.7% 2/12 • Number of events 3 • 12 months 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.
Infections and infestations Infection	0.00% 0/12 • 12 months 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.	8.3% 1/12 • Number of events 1 • 12 months 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.
Surgical and medical procedures Incision Opened	8.3% 1/12 • Number of events 1 • 12 months 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.	0.00% 0/12 • 12 months 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.
Skin and subcutaneous tissue disorders Hyperpigmentation	8.3% 1/12 • Number of events 1 • 12 months 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.	0.00% 0/12 • 12 months 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.
Skin and subcutaneous tissue disorders Skin Peeling	8.3% 1/12 • Number of events 1 • 12 months 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.	0.00% 0/12 • 12 months 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.
General disorders Headaches	8.3% 1/12 • Number of events 1 • 12 months 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.	8.3% 1/12 • Number of events 1 • 12 months 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.

Additional Information

Kristin Prosak

Neodyne Biosciences

Phone: 650-543-7129

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place