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Split-thickness skin graft (STSG) is a surgical procedure to repair losses of skin by transferring of a section of healthy skin (donor site) to replace the damaged tissue in another area of the body (recipient site). However, the patients will have a new wound at donor sites which need appropriate wound dressing to increase healing and reduce complications. Since silk sericin can form a dressing which can accelerate wound healing process and protect wound from environment, the aim of this study is to investigate how well silk sericin wound dressing cures STSG donor sites by comparing to Bactigras® which is a commonly used paraffin-impregnated fine mesh gauze. Silk sericin wound dressing is a promising material which can shorten the treatment course and reduce pain for the patients who have donor sites. This study design is a single-center, randomized, open and paralleled positive control study.18-60- year-old patients of both genders who undergo STSG at anterolateral thigh in Division of plastic and reconstructive surgery, King Chulalongkorn Memorial Hospital from April 2012 to January 2013 will be recruited in the study. The thickness of donor sites fall between 0.15-0.45 mm (0.006-0.018 inches) and their sizes are at least 100 cm2. The exclusion criteria are donor sites other than thigh or located at high risk of infection. Patients who are immunocompromised or mental defect, who are unlikely to comply with protocol or pregnant or lactating or known hypersensitivity to the investigational products are also excluded. All subjects sign the informed consents after an overall discussion of the protocol, its rationale and the potential risks. Donor sites are equally divided into 2 parts; upper and lower part of the leg. Using a random number table allocation, silk sericin wound dressing is randomly applied on one half and the other half will be covered by Bactigras®. Postoperatively, surgeons will observe all donor sites daily for treatment evaluation and any possible local adverse events without removing the primary dressings, except there is excessive fluid leakage or any sign of infection. Patients assess for pain level in every observations by using Visual Analog Scale. Time for complete epithelialisation is duration between finishing surgical procedure and the dressing spontaneously peeling off from donor sites without causing pain. If there is any sign of infection such as swelling, edema, purulent discharge, bad odor, a swab evaluation at the suspected area will be done to find an appropriate management. Blood sample will be collected from patients pre- and postoperatively (with in 24h, day3 and before patient discharge) for CBC, blood glucose, electrolyte, hepatic and renal function analysis and proinflammatory cytokine measurement. This study may show any possible adverse events, both local and systemic effect, caused by silk sericin dressing. Proinflammatory cytokines patterns of the patients underwent STSG will be revealed in this study which may be relate to clinical outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sericin scaffold | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sericin scaffold | Device | Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith&Nephew, London, UK) are applied on the other half of the skin graft donor site |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Efficacy of Wound Dressing Containing Silk Sericin for Split-thickness Skin Graft Donor Site Treatment | Time for complete epithalization is duration between finishing surgical procedure and the dressing spontaneously peeling off from donor sites without causing pain. The wounds completely close and without fluid leakage and are able to exposed to the environment without pain. This duration should not exceed than 14 days. | Within 14 days after operation |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Safety of Wound Dressing Containing Silk Sericin for Split-thickness Skin Graft Donor Site Treatment | Number of patients with infected wound | Within 14 days after operation |
| Pain Levels of Wounds |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chulalongkorn Hospital | Bangkok | 10330 | Thailand |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sericin Scaffold | Sericin scaffold: Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith&Nephew, London, UK) are applied on the other half of the skin graft donor site |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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Pain may occur on operation wounds. Visual analog scale is used by patients themselves for monitoring the pain level with 0 = no pain, 10 = worst possible pain.
| Within 14 days after operation |
| Proinflammatory Cytokines (IL) | The proinflammatory cytokines from wound exudate will be measured for predicting the inflammatory level. ELISA kit is used. | Within 14 days after operation |
| Liver Enzyme (AST) | Large, open wound may absorb some materials from wound dressing. If those materials are toxic, liver enzyme (a major organ for elimination of any toxicities) will be increased. | Within 14 days after operation |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sericin Scaffold | Sericin scaffold: Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith&Nephew, London, UK) are applied on the other half of the skin graft donor site |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Wound size | Mean | Standard Deviation | square centrimeter |
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| Body temperature | Mean | Standard Deviation | Degree celcius |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinical Efficacy of Wound Dressing Containing Silk Sericin for Split-thickness Skin Graft Donor Site Treatment | Time for complete epithalization is duration between finishing surgical procedure and the dressing spontaneously peeling off from donor sites without causing pain. The wounds completely close and without fluid leakage and are able to exposed to the environment without pain. This duration should not exceed than 14 days. | Posted | Mean | Standard Deviation | Days | Within 14 days after operation |
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| Secondary | Clinical Safety of Wound Dressing Containing Silk Sericin for Split-thickness Skin Graft Donor Site Treatment | Number of patients with infected wound | Posted | Number | Number of patients with infected wound | Within 14 days after operation |
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| Secondary | Pain Levels of Wounds | Pain may occur on operation wounds. Visual analog scale is used by patients themselves for monitoring the pain level with 0 = no pain, 10 = worst possible pain. | Posted | Mean | Standard Deviation | units on a scale | Within 14 days after operation |
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| Secondary | Proinflammatory Cytokines (IL) | The proinflammatory cytokines from wound exudate will be measured for predicting the inflammatory level. ELISA kit is used. | Posted | Mean | Standard Deviation | pg/mL | Within 14 days after operation |
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| Secondary | Liver Enzyme (AST) | Large, open wound may absorb some materials from wound dressing. If those materials are toxic, liver enzyme (a major organ for elimination of any toxicities) will be increased. | Posted | Mean | Standard Deviation | u/L | Within 14 days after operation |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sericin Scaffold | Sericin scaffold: Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith&Nephew, London, UK) are applied on the other half of the skin graft donor site | 0 | 30 | 2 | 30 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Itching | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Patients may experience itching around the operation wounds |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Pornanong Aramwit, Pharm.D., Ph.D. | Faculty of Pharmaceutical Sciences, Chulalongkorn University | +66899217255 | aramwit@gmail.com |
| ID | Term |
|---|---|
| D010148 | Pain, Intractable |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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