Clinical Efficacy and Safety of Sericin Hydrogel Sheet Impregnated With Bird's Nest Extract

Wound Clinical Trial

Official title:

Clinical Efficacy and Safety of Sericin Hydrogel Sheet Impregnated With Bird's Nest Extract in Prevention of Hypertrophic Scar Development at Split-thickness Skin Graft Donor Site

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04997863
• Other study ID #: Med Chula IRB 572/64
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: September 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

Split-thickness skin graft (STSG) is one of the most common procedures performed in plastic surgery and dermatology. The donor site of skin grafting is expected to heal without scarring. However, hypertrophic scar formation is prevalent among STSG donor sites during scar maturation and has become a significant problem at present. Hypertrophic scar results in aesthetic, physical, functional, and psychological problems, leading to a dramatic impact on patients' quality of life ultimately. There are many current therapeutic approaches for preventing and treating hypertrophic scars; however, they remain clinically unsatisfactory because many treatments have been associated with high recurrent rates, high cost, and side effects. Currently, there are no gold standards for hypertrophic scar therapy. There are many attempts to develop new treatment options for the prevention and management of scarring that are acceptable to both physicians and patients. It has previously been shown that both edible bird's nest (EBN) extract and sericin have effectiveness in reducing scar development. They might be a suitable alternative option for scar prevention and could be used safely. Therefore, the sericin hydrogel sheet impregnated with EBN extract is developed as it is believed that the synergism of these combined compounds would be a great help to prevent the development of scars. This study aims to evaluate the efficacy and safety of sericin hydrogel sheet impregnated with EBN extract for the prevention of scar formation in patients with STSG donor sites.

Description:

Prospective, randomized, single-center, double-blinded, placebo-controlled, matched pairs clinical study will be conducted to investigate the efficacy and safety of sericin hydrogel sheet impregnated with EBN extract for the prevention of scar development at STSG donor site. Patients who underwent the STSG procedure at the Division of Plastic and Reconstructive Surgery, Department of Surgery, King Chulalongkorn Memorial Hospital will be considered for inclusion and exclusion criteria. Thirty patients will be enrolled in this study. After complete epithelialization, each donor site will be equally divided into two halves: upper and lower halves. Both halves of the donor site will be randomized into sericin hydrogel sheet impregnated with EBN extract group (treatment group) or placebo hydrogel sheet group (control group). The application of both dressings will be done once daily by the patient in the morning or evening after shower. Both dressings will be recommended to wear over the donor site for 8-12 hours per day. The duration of treatment will be six months. Wound quality at 1, 2, 4, and 6 months after starting application will be measured in terms of erythema level, melanin level, transepidermal water loss by using Cutometer® and scar quality (Vancouver scar scale as well as Patient and Observer Scar Assessment Scale). Adverse reactions will also be evaluated.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• STSG donor sites freshly closed not more than 1 month after completed epithelialization

• STSG donor sites are at least 5 x 10 cm2 in size.

• STSG donor sites are located on the thigh.

• Donor sites have not been used previously for skin graft harvesting.

• Aged 18-65 years

• Patients who can read and write Thai language

• Willingness to participate

• Signed consent form

Exclusion Criteria:

• Patients with critical illness (such as systemic infection), major acute illness, or chronic medical illness associated with delayed wound healing (such as poor-controlled diabetes mellitus, end-stage renal disease (ESRD), cancer, or immunocompromised diseases)

• Patients with mental disorder

• Patients with active dermatologic conditions such as contractive skin disorders (e.g., scleroderma), psoriasis, or atopic dermatitis

• After completed epithelialization, patients who used other topical agents or dressings on STSG donor sites within 14 days prior to enrollment

• Known sensitivity or allergy to sericin, EBN, other constituents in hydrogel sheet, or adhesive tape

• Pregnancy

Related Conditions & MeSH terms

• Cicatrix
• Donor Site Complication
• Fibrosis
• Skin Graft Scar
• Wound

Intervention

Device:
• Sericin hydrogel sheet impregnated with EBN extract
Sericin hydrogel sheet impregnated with EBN extract will be used as a primary dressing for preventing scar development at one-half of the STSG donor site. Then, the donor site will be covered with adhesive tape (secondary dressing). The application of primary and secondary dressings will be done once daily after shower in the morning or evening. Both dressings will be recommended to wear over the donor site for 8-12 hours per day. Patients will be advised to remove both dressings before shower to clean the donor site and the surrounding skin, and then replace them with new wound dressing sheets in the next day. The duration of the dressing application will be 6 months.
• Placebo hydrogel sheet
Placebo hydrogel sheet will be used as a primary dressing for preventing scar development at another half of the STSG donor site. Then, the donor site will be covered with adhesive tape (secondary dressing). The application of primary and secondary dressings will be done once daily after shower in the morning or evening. Both dressings will be recommended to wear over the donor site for 8-12 hours per day. Patients will be advised to remove both dressings before shower to clean the donor site and the surrounding skin, and then replace them with new wound dressing sheets in the next day. The duration of the dressing application will be 6 months.

Locations

Country	Name	City	State
Thailand	King Chulalongkorn Memorial 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	Vancouver Scar Scale (VSS) score	Clinicians will evaluate scar quality using VSS at 6 months after commencing the dressing application. The range of score is 0 to 10. Higher scores mean a worse outcome.	6 months
Secondary	Patient and Observer Scar Assessment Scale (POSAS) score	Clinicians will evaluate scar quality using POSAS at 1, 2, 4, and 6 months after commencing the dressing application. The range of score is 1 to 10. Normal skin will be recorded as scale 1. Higher scores mean a worse outcome.	6 months
Secondary	Melanin level	Melanin level will be measured using Cutometer® with mexameter mode at 1, 2, 4, and 6 months after commencing the dressing application.	6 months
Secondary	Erythema level	Erythema level will be measured using Cutometer® with mexameter mode at 1, 2, 4, and 6 months after commencing the dressing application.	6 months
Secondary	Transepidermal water loss (TEWL)	TEWL will be measured using Cutometer® with tewameter mode at 1, 2, 4, and 6 months after commencing the dressing application.	6 months
Secondary	Adverse events	Adverse events resulted from dressing application will be evaluated.	6 months