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

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.

Study Overview

• Status: Unknown
• Conditions: Wound Heal; Wound Surgical; Donor Site Complication
• Intervention / Treatment: Other: wound dressing application

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pornanong Aramwit, Ph.D; Phone Number: +66899217255; Email: aramwit@gmail.com

Study Locations

• Thailand
  • Bangkok, Thailand, 10330
    • Recruiting
    • Chulalongkorn Hospital
    • Principal Investigator: Pornanong Aramwit, Ph.D.
    • Contact: Pornanong Aramwit, Ph.D.; Phone Number: +66-89-9217255; Email: aramwit@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sericin dressing with collagen	Other: wound dressing application; Sericin dressing with collagen or Bactigras will be used as a primary dressing for treating the STSG donor site.
Active Comparator: Bactigras; Commercial dressing	Other: wound dressing application; Sericin dressing with collagen or Bactigras will be used as a primary dressing for treating the STSG donor site.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Chulalongkorn University
• Investigators: Principal Investigator: Pornanong Aramwit, Ph.D, Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn University

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2021
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: February 4, 2021
• First Submitted That Met QC Criteria: February 4, 2021
• First Posted (Actual): February 8, 2021

Study Record Updates

• Last Update Posted (Actual): February 8, 2021
• Last Update Submitted That Met QC Criteria: February 4, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Collagen; Sericin; Wound dressing; Split-thickness skin graft donor site (STSG donor site)
• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: Med Chula IRB 143/63

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No