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

Wound Heal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04743375
• Other study ID #: Med Chula IRB 143/63
• Status: Recruiting
• Phase: N/A
• Start date: February 2021
• Est. completion date: December 2021

Study information

• Verified date: February 2021
• Source: Chulalongkorn University
• Contact: Pornanong Aramwit, Ph.D
• Phone: +66899217255
• Email: aramwit[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Donor Site Complication
• Wound Heal
• Wound Surgical
• Wounds and Injuries

Intervention

Other:
• wound dressing application
Sericin dressing with collagen or Bactigras will be used as a primary dressing for treating the STSG donor site.

Locations

Country	Name	City	State
Thailand	Chulalongkorn Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Pain score	Pain score evaluated by patient using visual analog scales (0-10)	42 days
Secondary	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.	42 days
Secondary	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
Secondary	Vancouver scar scale (VSS)	Vancouver scar scale evaluated by clinician at 1, 3, and 6 months after complete wound healing	6 months
Secondary	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
Secondary	Erythema level	Erythema level measured by using Mexameter® at 1, 3, and 6 months after complete wound healing	6 months
Secondary	Melanin level	Melanin level measured by using Mexameter® at 1, 3, and 6 months after complete wound healing	6 months
Secondary	Trans-epidermal water loss (TEWL)	TEWL measured by using Tewameter® at 1, 3, and 6 months after complete wound healing	6 months
Secondary	Skin hydration	Hydration level measured by using Corneometer® at 1, 3, and 6 months after complete wound healing	6 months
Secondary	Skin elasticity	Elasticity parameters measured by using Cutometer® at 1, 3, and 6 months after complete wound healing	6 months