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To examine the efficacy and safety of sericin dressing with collagen in STSG donor site treatment comparing with Bactigras®. Around 30 patients will be enrolled in this study.
Wounds are a public health problem found worldwide that associated with both clinical and economic burdens. Although several wound dressings are available, some limitations of those dressings still existed resulting in the need for new wound dressing development.
The sericin dressing with collagen was developed to provide a moist environment and bioactive ingredients to the wound bed. To evaluate its efficacy and safety, the STSG donor sites of each patient will be divided into two equal areas. Each area will be randomly allocated into sericin dressing with collagen group or control group (Bactigras®). The outcomes will be collected to examine the efficacy and safety of sericin dressing with collagen in comparison with commercial dressing Bactigras®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sericin dressing with collagen | Experimental | Sericin dressing with collagen |
|
| Bactigras | Active Comparator | Commercial dressing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| wound dressing application | Other | Sericin dressing with collagen or Bactigras will be used as a primary dressing for treating the STSG donor site. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to complete healing | The number of days since starting treatment until the primary dressing can spontaneously detach from wound with full re-epithelialization (at least 95% re-epithelialization) without any drainage. | 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pain score | Pain score evaluated by patient using visual analog scales (0-10) | 42 days |
| Incidence of infection | The incidence of infection will be reported as "present" or "not present". Infection wound is wound which has purulent secretion or some of the inflammatory reactions (erythema, warmth, pain or tenderness, or induration) and has positive result from microbiological test. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pornanong Aramwit, Ph.D | Contact | +66899217255 | aramwit@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Pornanong Aramwit, Ph.D | Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chulalongkorn Hospital | Recruiting | Bangkok | 10330 | Thailand |
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| ID | Term |
|---|---|
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| 42 days |
| Incidence of adverse effect | Adverse effects on hepatic function, renal function, and other adverse effects resulted from dressing application will be reported as "present" or "not present". | 42 days |
| Vancouver scar scale (VSS) | Vancouver scar scale evaluated by clinician at 1, 3, and 6 months after complete wound healing | 6 months |
| Patient scale of Patient and observer scar scale (POSAS) | Patient scale of Patient and observer scar scale (POSAS) evaluated by patients 6 months after complete wound healing | 6 months |
| Erythema level | Erythema level measured by using Mexameter® at 1, 3, and 6 months after complete wound healing | 6 months |
| Melanin level | Melanin level measured by using Mexameter® at 1, 3, and 6 months after complete wound healing | 6 months |
| Trans-epidermal water loss (TEWL) | TEWL measured by using Tewameter® at 1, 3, and 6 months after complete wound healing | 6 months |
| Skin hydration | Hydration level measured by using Corneometer® at 1, 3, and 6 months after complete wound healing | 6 months |
| Skin elasticity | Elasticity parameters measured by using Cutometer® at 1, 3, and 6 months after complete wound healing | 6 months |