Pain, Intractable Clinical Trial
Official title:
Clinical Efficacy of Wound Dressing Containing Silk Sericin for Split-thickness Skin Graft Donor Site Treatment
Verified date | April 2015 |
Source | Chulalongkorn University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Thailand: Food and Drug Administration |
Study type | Interventional |
1. Silk sericin wound dressing may reduce time for complete epithelialisation of
split-thickness skin graft donor sites compared to Bactigras®.
2. Silk sericin wound dressing may reduce pain level at split-thickness skin graft donor
sites compared to Bactigras® .
3. Silk sericin wound dressing may not cause split-thickness skin graft donor sites
infection as compared to Bactigras®.
4. Split-thickness skin graft donor sites which treat by silk sericin wound dressing may
not cause significant adverse events.
Status | Completed |
Enrollment | 30 |
Est. completion date | April 2014 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Aged 18-60 years - Patients who require STSG such as burn, trauma, venous ulcers, or surgical removal of cutaneous malignancies etc. - Patients whom surgeons assess that ready for undergoing STSG - Sufficient normal skin at anterolateral thigh area for 1 or more STSG donor sites - 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 - Patients who are willing to participate in the trial and to sign the informed consent form. Exclusion Criteria: - Use others area for STSG donor sites other than thigh - Donor sites are located at high risk of infection such as harvesting closed to current infective wound (excessive purulent discharge or bad odor) - Patients who are immunocompromised or mental defect - Patients who cannot or not willing to comply with the study protocol - Known allergy or hypersensitivity reaction to silk sericin or chlorhexidine acetate - Pregnancy or lactation |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Thailand | Chulalongkorn Hospital | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Chulalongkorn University |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | Within 14 days after operation | Yes |
Secondary | 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 | Yes |
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. | Within 14 days after operation | Yes |
Secondary | 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 | Yes |
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. | Within 14 days after operation | Yes |
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