Split-thickness Skin Graft Donor Sites
Conditions
Keywords
Split-thickness skin graft, donor site, chitosan, dressing
Brief summary
The purpose of this single center, prospective case series is to evaluate the effective management of split-thickness skin graft donor site wounds using Opticell Ag (Chitosan-based dressing).
Interventions
DEVICEOpticell Ag
Opticell Ag+ applied to STSG donor site
Sponsors
Medline Industries
Brigham and Women's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Opticell Ag dressing applied to STSG donor site
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Inpatient status at study site * Subject must be receiving a split-thickness skin graft (STSG) * Wounds must not exceed 10% total body surface area (TBSA) * Any donor site * Ability to comply with necessary wound care/follow up
Exclusion criteria
* Subject is pregnant * Subject has been diagnosed with Diabetes * Subject is a smoker * Subject takes steroids * Subject is sensitive and/or allergic to shellfish and/or silver * Wounds that exceed 10% total body surface area (TBSA) * Inability to comply with necessary wound care/follow up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain | Assessed up to 14 days of use | 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. |
| Wound Healing Rate (Re-epithelialization) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound Healing Quality | 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. |
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 19 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Opticell Ag |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| Allergies to chitosan/shellfish | 0 Participants |
| Dermatome setting | 0.0122 inches |
| Donor site area | 196.9 square centimeters |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Reason for split-thickness skin graft Burn | 16 Participants |
| Reason for split-thickness skin graft Soft tissue defect | 3 Participants |
| Region of Enrollment United States | 19 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 19 |
| other Total, other adverse events | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
Primary
Pain
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Opticell Ag | Pain | Mean Day 1 | 4.2 units on a scale | Standard Deviation 3.2 |
| Opticell Ag | Pain | Mean Day 5-7 | 2.5 units on a scale | Standard Deviation 2.2 |
| Opticell Ag | Pain | Mean Day 10-14 | 1.1 units on a scale | Standard Deviation 1 |
Primary
Wound Healing Rate (Re-epithelialization)
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.
Time frame: Assessed up to 1 month postoperatively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Opticell Ag | Wound Healing Rate (Re-epithelialization) | Day 10-14 | 92.3 percent (%) | Standard Deviation 8.9 |
| Opticell Ag | Wound Healing Rate (Re-epithelialization) | 1 month | 99.5 percent (%) | Standard Deviation 1 |
Secondary
Wound Healing Quality
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.
Time frame: Assessed up to 1 month of use
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Opticell Ag | Wound Healing Quality | 3 units on a scale | Standard Deviation 1.4 |