Clinical Efficacy of Silk Sericin Dressing With Collagen for Split-thickness Skin Graft Donor Site Treatment

Chulalongkorn University

Status: Unknown

Conditions: Wound Surgical; Donor Site Complication; Wound Heal

Treatments: Other: wound dressing application

Study type: Interventional

Funder types: Other

Identifiers

NCT04743375

Med Chula IRB 143/63

Details and patient eligibility

About

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.

Full 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®.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

30 participants in 2 patient groups

Sericin dressing with collagen

Experimental group

Description:

Sericin dressing with collagen

Treatment:

Other: wound dressing application

Bactigras

Active Comparator group

Description:

Commercial dressing

Treatment:

Other: wound dressing application