Disorder of Skin Donor Site
Conditions
Brief summary
High absorption pad for blood and pus with natural antimicrobial agent or gauze dressing impregnated with paraffin, containing 0.5% chlorhexidine acetate (Bactigras) will be randomly covered on half of split-thickness skin graft donor site wound. The another will be cover on another half of split-thickness skin graft donor site wound. Then, they will be covered with gauzes and bandage. Time to wound healing, amounts of covered dressing gauzes, signs of infection, pain score, erythema index, melanin index, trans epidermal water loss index, and adverse events will be evaluated.
Interventions
DEVICEhigh absorption pad for blood and pus
High absorption pad for blood and pus will be covered on half of split-thickness skin graft donor site wound until the wound has healed.
DEVICEcommercial wound dressing
Commercial wound dressing will be covered on half of split-thickness skin graft donor site wound until the wound has healed.
Sponsors
Chulalongkorn University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Have split-thickness skin graft donor site wound on thigh * Age 18-60 years * Can read and write * Can follow the study protocol * Available on appointment date
Exclusion criteria
* Systemic infection * Chronic skin diseases * Immune deficiency * Allergic to cellulose, chitosan, sericin, and chlorhexidine * Psychotic disorders * Pregnancy or breast feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| wound healing time | not more than 28 days | The day that the dressing will detach without painful. |
| amounts of secondary gauze dressing | not more than 28 days | The amounts of secondary gauze dressing that will be changed because of blood over capacity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pain score | 5 days after donor site wound was created | Pain score will be evaluated using visual analogue scale. The 0 and 10 scores mean no pain and very pain, respectively. Higher score means more painful. |
| signs of infection | not more than 28 days | Signs of infection mean pain, swollen, red, and warn including pus on the wound. |
| scar melanin index | 3 months | Scar melanin index will be measured using Cutometer (Mexameter). There is no unit. Higher value mean higher risk of post inflammatory reaction. |
| scar erythema index | 3 months | Scar erythema index will be measured using Cutometer (Mexameter). There is no unit. Higher value mean higher risk of post inflammatory reaction. |
| transepidermal water loss index | 3 months | Transepidermal water loss index of scar will be measured using Cutometer (Tewameter). There is no unit. Higher value mean higher risk of unhealthy scar. |
| scar quality | 3 months | Scar quality will be evaluated using vancouver scar scale. The 0 and 13 scores mean high scar quality and low scar quality , respectively. Higher score means low scar quality. |
| adverse events | not more than 28 days | Adverse events will be observed. They will be recorded as present or not present. |
| aspartate aminotransferase in serum | not more than 28 days | Aspartate aminotransferase in serum (in U/L) after treatment will not be more than before treatment. |
| alanine aminotransferase in serum | not more than 28 days | Alanine aminotransferase in serum (in U/L) after treatment will not be more than before treatment. |
| blood urea nitrogen | not more than 28 days | Blood urea nitrogen (in mg/dl) after treatment will not be more than before treatment. |
| serum creatinine | not more than 28 days | Serum creatinine (in mg/dl) after treatment will not be more than before treatment. |
Countries
Thailand
Contacts
Primary ContactPornanong Aramwit, Ph.D
Outcome results
None listed