Efficacy and Safety of High Absorption Pad in Split-thickness Skin Graft Donor Site Wound
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: high absorption pad for blood and pus 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
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.
|
| Active Comparator: commercial wound dressing 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
Commercial wound dressing will be covered on half of split-thickness skin graft donor site wound until the wound has healed.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Have split-thickness skin graft donor site wound on thigh
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Age 18-60 years
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Can read and write
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Can follow the study protocol
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Available on appointment date
Exclusion Criteria:
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Systemic infection
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Chronic skin diseases
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Immune deficiency
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Allergic to cellulose, chitosan, sericin, and chlorhexidine
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Psychotic disorders
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Pregnancy or breast feeding
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity | Bangkok | Thailand | 10310 |
Sponsors and Collaborators
- Chulalongkorn University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 625/62