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

NCT04997863 | Unknown

• 1 other identifier: Med Chula IRB 572/64
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Wound; Donor Site Complication; Skin Graft Scar; Scar Conditions and Fibrosis of Skin

Keywords

Sericin; Bird's nest; Hydrogel; Hypertrophic scar; Split-thickness skin graft; Donor site

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Patient and Observer Scar Assessment Scale (POSAS) score

  6 months

• Melanin level

  6 months

• Erythema level

  6 months

• Transepidermal water loss (TEWL)

  6 months

• Adverse events

  6 months

Study Arms (2)

Sericin hydrogel sheet impregnated with EBN extract

EXPERIMENTAL

Apply sericin hydrogel sheet impregnated with EBN extract on one-half of the donor site once daily for 8-12 hours per day for 6 months.

Device: Sericin hydrogel sheet impregnated with EBN extract

Placebo hydrogel sheet

PLACEBO COMPARATOR

Apply placebo hydrogel sheet on another half of the donor site once daily for 8-12 hours per day for 6 months.

Device: Placebo hydrogel sheet

Interventions

Sericin hydrogel sheet impregnated with EBN extract DEVICE

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.

Sericin hydrogel sheet impregnated with EBN extract

Placebo hydrogel sheet DEVICE

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.

Placebo hydrogel sheet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

King Chulalongkorn Memorial Hospital

Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Wounds and Injuries; Cicatrix, Hypertrophic

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pornanong Aramwit, Ph.D

  Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pornanong Aramwit, Ph.D

CONTACT

+66899217255; aramwit@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 10, 2021
• Study Start: November 1, 2021
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: September 24, 2021

Record last verified: 2021-09

Locations

TH (1)