Efficacy and Safety of High Absorption Pad in Split-thickness Skin Graft Donor Site Wound

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety of High Absorption Pad for Blood and Pus With Natural Antimicrobial Agent in Split-thickness Skin Graft Donor Site Wound

Conditions
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Disorder of Skin Donor Site

Intervention / Treatment
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* Device: high absorption pad for blood and pus
* Device: commercial wound dressing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high absorption pad for blood and pus<br>High absorption pad for blood and pus with natural antimicrobial agent composes of sericin and chitosan. It will be covered on half of split-thickness skin graft donor site wound until the wound has healed. | Device: high absorption pad for blood and pus<br>* 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.<br>|
| Active Comparator: commercial wound dressing<br>Commercial wound dressing is gauze dressing impregnated with paraffin, containing 0.5% chlorhexidine acetate (Bactigras). It will be covered on half of split-thickness skin graft donor site wound until the wound has healed. | Device: commercial wound dressing<br>* Commercial wound dressing will be covered on half of split-thickness skin graft donor site wound until the wound has healed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wound healing time | The day that the dressing will detach without painful. | not more than 28 days | 
| amounts of secondary gauze dressing | The amounts of secondary gauze dressing that will be changed because of blood over capacity. | not more than 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain score | 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. | 5 days after donor site wound was created | 
| signs of infection | Signs of infection mean pain, swollen, red, and warn including pus on the wound. | not more than 28 days | 
| scar melanin index | Scar melanin index will be measured using Cutometer (Mexameter). There is no unit. Higher value mean higher risk of post inflammatory reaction. | 3 months | 
| scar erythema index | Scar erythema index will be measured using Cutometer (Mexameter). There is no unit. Higher value mean higher risk of post inflammatory reaction. | 3 months | 
| transepidermal water loss index | Transepidermal water loss index of scar will be measured using Cutometer (Tewameter). There is no unit. Higher value mean higher risk of unhealthy scar. | 3 months | 
| scar quality | 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. | 3 months | 
| adverse events | Adverse events will be observed. They will be recorded as present or not present. | not more than 28 days | 
| aspartate aminotransferase in serum | Aspartate aminotransferase in serum (in U/L) after treatment will not be more than before treatment. | not more than 28 days | 
| alanine aminotransferase in serum | Alanine aminotransferase in serum (in U/L) after treatment will not be more than before treatment. | not more than 28 days | 
| blood urea nitrogen | Blood urea nitrogen (in mg/dl) after treatment will not be more than before treatment. | not more than 28 days | 
| serum creatinine | Serum creatinine (in mg/dl) after treatment will not be more than before treatment. | not more than 28 days |