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Trial Outcomes & Findings for Evaluation of Opticell Ag on Split-Thickness Skin Graft Donor Sites in Adult Subjects (NCT NCT02642679)

NCT ID: NCT02642679

Last Updated: 2017-12-08

Results Overview

Pain reported by Subject using a visual analog scale (VAS). This scale measures an unidimensional measure of pain intensity by means of a continuous scale comprised of a horizontal line, 10 centimeters (100 mm) in length. The left side of the scale signifies no pain (score of 0), and the right side the other extreme, worst pain imaginable (score of 10). Patients are asked to place a line perpendicular to the VAS scale at the point that represents their pain intensity.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

19 participants

Primary outcome timeframe

Assessed up to 14 days of use

Results posted on

2017-12-08

Participant Flow

Patients scheduled to undergo split-thickness skin graft harvesting in the Divisions of Burn and Plastic Surgery at the Brigham and Women's Hospital during the period of time from January to December 2016 were identified as possible study candidates.

Enrolled participants were excluded from the study prior to experimental dressing application if they were found unable to comply with necessary wound care/follow up, or if their surgeon requested they no longer be enrolled.

Participant milestones

Participant milestones
Measure
Opticell Ag
Opticell Ag covered with a transparent occlusive dressing (Tegaderm) with evenly distributed perforations which permit a controlled leakage into a layer of cotton gauze pads placed directly over the Opticell Ag and occlusive dressing combination. Opticell Ag: Opticell Ag+ applied to STSG donor site
Overall Study
STARTED
19
Overall Study
COMPLETED
16
Overall Study
NOT COMPLETED
3

Reasons for withdrawal

Reasons for withdrawal
Measure
Opticell Ag
Opticell Ag covered with a transparent occlusive dressing (Tegaderm) with evenly distributed perforations which permit a controlled leakage into a layer of cotton gauze pads placed directly over the Opticell Ag and occlusive dressing combination. Opticell Ag: Opticell Ag+ applied to STSG donor site
Overall Study
Withdrawal by Subject
1
Overall Study
Physician Decision
1

Baseline Characteristics

Evaluation of Opticell Ag on Split-Thickness Skin Graft Donor Sites in Adult Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Opticell Ag
n=19 Participants
Opticell Ag covered with a transparent occlusive dressing (Tegaderm) with evenly distributed perforations which permit a controlled leakage into a layer of cotton gauze pads placed directly over the Opticell Ag and occlusive dressing combination. Opticell Ag: Opticell Ag+ applied to STSG donor site
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
16 Participants
n=5 Participants
Age, Categorical
>=65 years
3 Participants
n=5 Participants
Sex: Female, Male
Female
7 Participants
n=5 Participants
Sex: Female, Male
Male
12 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
15 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
3 Participants
n=5 Participants
Race (NIH/OMB)
White
15 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
19 Participants
n=5 Participants
Allergies to chitosan/shellfish
0 Participants
n=5 Participants
Reason for split-thickness skin graft
Burn
16 Participants
n=5 Participants
Reason for split-thickness skin graft
Soft tissue defect
3 Participants
n=5 Participants
Donor site area
196.9 square centimeters
n=5 Participants
Dermatome setting
0.0122 inches
n=5 Participants

PRIMARY outcome

Timeframe: Assessed up to 14 days of use

Population: Pain was evaluated on postoperative day 1, before the dressing was changed on days 5-7, and before and after dressing removal on days 10-14 using the Visual Analog Scale (VAS). The patient was asked to mark his/her pain level on the line between the two endpoints.

Pain reported by Subject using a visual analog scale (VAS). This scale measures an unidimensional measure of pain intensity by means of a continuous scale comprised of a horizontal line, 10 centimeters (100 mm) in length. The left side of the scale signifies no pain (score of 0), and the right side the other extreme, worst pain imaginable (score of 10). Patients are asked to place a line perpendicular to the VAS scale at the point that represents their pain intensity.

Outcome measures

Outcome measures
Measure
Opticell Ag
n=16 Participants
Opticell Ag covered with a transparent occlusive dressing (Tegaderm) with evenly distributed perforations which permit a controlled leakage into a layer of cotton gauze pads placed directly over the Opticell Ag and occlusive dressing combination. Opticell Ag: Opticell Ag+ applied to STSG donor site
Pain
Mean Day 1
4.2 units on a scale
Standard Deviation 3.2
Pain
Mean Day 5-7
2.5 units on a scale
Standard Deviation 2.2
Pain
Mean Day 10-14
1.1 units on a scale
Standard Deviation 1

PRIMARY outcome

Timeframe: Assessed up to 1 month postoperatively.

The extent of re-epithelialization was evaluated by the surgeon and a blinded expert using photographs taken on days 10-14 and at 1 month postoperatively.

Outcome measures

Outcome measures
Measure
Opticell Ag
n=16 Participants
Opticell Ag covered with a transparent occlusive dressing (Tegaderm) with evenly distributed perforations which permit a controlled leakage into a layer of cotton gauze pads placed directly over the Opticell Ag and occlusive dressing combination. Opticell Ag: Opticell Ag+ applied to STSG donor site
Wound Healing Rate (Re-epithelialization)
Day 10-14
92.3 percent (%)
Standard Deviation 8.9
Wound Healing Rate (Re-epithelialization)
1 month
99.5 percent (%)
Standard Deviation 1

SECONDARY outcome

Timeframe: Assessed up to 1 month of use

Assessed using the Vancouver scar scale (VSS) 1-month post-operatively. The VSS is a widely used scale in clinical practice to document change in scar appearance. The scale scores four parameters: pigmentation, vascularity, pliability, and height for a total of 13 points. Normal appearance in each of the parameters garners a score of 0 and scores get higher (2-3) as an increase in parameters is observed. The lower the score, the better the outcome.

Outcome measures

Outcome measures
Measure
Opticell Ag
n=16 Participants
Opticell Ag covered with a transparent occlusive dressing (Tegaderm) with evenly distributed perforations which permit a controlled leakage into a layer of cotton gauze pads placed directly over the Opticell Ag and occlusive dressing combination. Opticell Ag: Opticell Ag+ applied to STSG donor site
Wound Healing Quality
3 units on a scale
Standard Deviation 1.4

Adverse Events

Opticell Ag

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Indranil Sinha, MD

Brigham and Women's Hospital

Phone: 617-732-5282

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place