Clinical Efficacy of Silk Sericin Dressing With Collagen for Split-thickness Skin Graft Donor Site Treatment
- Conditions
- Wound HealDonor Site ComplicationWound Surgical
- Interventions
- Other: wound dressing application
- Registration Number
- NCT04743375
- Lead Sponsor
- Chulalongkorn University
- Brief Summary
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.
- Detailed Description
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®.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- Patients who have STSG donor site wounds on the thigh area
- Age more than 18 years old
- The split-thickness skin graft is harvested for the first time at the investigated area.
- Patients who are able to communicate with the Thai language
- Willingness to participate
- Patient with a mental disorder or immunocompromised diseases
- Patients who cannot or not willing to follow the protocol
- Known sensitivity or allergy to sericin, chlorhexidine, and collagen
- Pregnancy or lactation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bactigras wound dressing application Commercial dressing Sericin dressing with collagen wound dressing application Sericin dressing with collagen
- Primary Outcome Measures
Name Time Method Time to complete healing 42 days 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.
- Secondary Outcome Measures
Name Time Method Incidence of infection 42 days 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.
Incidence of adverse effect 42 days Adverse effects on hepatic function, renal function, and other adverse effects resulted from dressing application will be reported as "present" or "not present".
Pain score 42 days Pain score evaluated by patient using visual analog scales (0-10)
Vancouver scar scale (VSS) 6 months Vancouver scar scale evaluated by clinician at 1, 3, and 6 months after complete wound healing
Patient scale of Patient and observer scar scale (POSAS) 6 months Patient scale of Patient and observer scar scale (POSAS) evaluated by patients 6 months after complete wound healing
Melanin level 6 months Melanin level measured by using Mexameter® at 1, 3, and 6 months after complete wound healing
Trans-epidermal water loss (TEWL) 6 months TEWL measured by using Tewameter® at 1, 3, and 6 months after complete wound healing
Skin hydration 6 months Hydration level measured by using Corneometer® at 1, 3, and 6 months after complete wound healing
Erythema level 6 months Erythema level measured by using Mexameter® at 1, 3, and 6 months after complete wound healing
Skin elasticity 6 months Elasticity parameters measured by using Cutometer® at 1, 3, and 6 months after complete wound healing
Trial Locations
- Locations (1)
Chulalongkorn Hospital
🇹🇭Bangkok, Thailand