Clinical Efficacy of Silk Sericin Dressing With Collagen for Split-thickness Skin Graft Donor Site Treatment
Overview
- Phase
- Not Applicable
- Sponsor
- Chulalongkorn University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Time to complete healing
Overview
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®.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Time to complete healing
Time Frame: 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 Outcomes
- Incidence of infection(42 days)
- Incidence of adverse effect(42 days)
- Pain score(42 days)
- Vancouver scar scale (VSS)(6 months)
- Patient scale of Patient and observer scar scale (POSAS)(6 months)
- Melanin level(6 months)
- Trans-epidermal water loss (TEWL)(6 months)
- Skin hydration(6 months)
- Erythema level(6 months)
- Skin elasticity(6 months)
Investigators
Pornanong Aramwit, Pharm.D., Ph.D
Professor
Chulalongkorn University