Skin Graft
Conditions
Keywords
Skin graft donor site healing, skin, wound, platelet concentrate, keratinocytes, burns
Brief summary
This prospective randomized trial evaluated the impact of autologous keratinocytes suspended in platelet concentrates on healing skin graft donor site wounds. It was hypothesized that the treatment would speed and improve wound healing.
Interventions
BIOLOGICALAutologous Platelet Rich Plasma
Platelet Rich Plasma isolated from patient blood sprayed onto wound bed along with 10% Calcium Chloride solution in a 10 to 1 proportion.
BIOLOGICALKeratinocyte suspension
Autologous keratinocytes isolated from skin biopsy suspended in platelet rich plasma before spraying.
OTHERStandard dressings
Three layers of paraffin gauze, topped with standard dry bandages and an elastic bandage.
Sponsors
Centre Hospitalier Universitaire Vaudois
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Skin graft donor sites total surface \< 15% BSA * Skin graft donor site size: 0.2mm deep, 30 to 40 cm2 surface area
Exclusion criteria
* Patients treated with immunosuppressors * Patients treated with corticoids * Patients suffering from terminal renal insufficiency * Patients suffering from severe peripheral arteriopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Wound Healing | Post operative day 5 and every other day thereafter | Time required for complete epithelialization in days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain | Post operative day 5 | Pain evaluated on a Visual Analog Scale (VAS) from 0 (no pain) to 10 (extreme pain), specifically during dressing replacement. |
Countries
Switzerland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Wounds covered with standard dressings: three layers of paraffin gauze, standard bandages, elastic bandage. | 15 |
| PRP Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group. | 15 |
| PRP+K Keratinocytes suspended in Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group. | 15 |
| Total | 45 |
Baseline characteristics
| Characteristic | Control | PRP | PRP+K | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 3 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 14 Participants | 12 Participants | 41 Participants |
| Age Continuous | 42.5 years STANDARD_DEVIATION 11.9 | 45.5 years STANDARD_DEVIATION 15.3 | 46.9 years STANDARD_DEVIATION 20.5 | 44.7 years STANDARD_DEVIATION 16.2 |
| Sex: Female, Male Female | 4 Participants | 6 Participants | 10 Participants | 20 Participants |
| Sex: Female, Male Male | 11 Participants | 9 Participants | 5 Participants | 25 Participants |
Outcome results
Primary
Complete Wound Healing
Time required for complete epithelialization in days
Time frame: Post operative day 5 and every other day thereafter
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Complete Wound Healing | 13.9 Days | Standard Deviation 2 |
| PRP | Complete Wound Healing | 7.2 Days | Standard Deviation 0.8 |
| PRP+K | Complete Wound Healing | 5.7 Days | Standard Deviation 0.7 |
p-value: 0.05ANOVA
Secondary
Pain
Pain evaluated on a Visual Analog Scale (VAS) from 0 (no pain) to 10 (extreme pain), specifically during dressing replacement.
Time frame: Post operative day 5
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Pain | 7.2 VAS Pain Score | Standard Deviation 0.7 |
| PRP | Pain | 1.5 VAS Pain Score | Standard Deviation 0.9 |
| PRP+K | Pain | 0.4 VAS Pain Score | Standard Deviation 0.7 |
p-value: 0.05ANOVA