Clinical Efficacy and Safety of Sericin Hydrogel Sheet Impregnated With Bird's Nest Extract
Primary Purpose
Wound, Donor Site Complication, Skin Graft Scar
Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Sericin hydrogel sheet impregnated with EBN extract
Placebo hydrogel sheet
Sponsored by
About this trial
This is an interventional prevention trial for Wound focused on measuring Sericin, Bird's nest, Hydrogel, Hypertrophic scar, Split-thickness skin graft, Donor site
Eligibility Criteria
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
Sites / Locations
- King Chulalongkorn Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Sericin hydrogel sheet impregnated with EBN extract
Placebo hydrogel sheet
Arm Description
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.
Apply placebo hydrogel sheet on another half of the donor site once daily for 8-12 hours per day for 6 months.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Melanin level
Melanin level will be measured using Cutometer® with mexameter mode at 1, 2, 4, and 6 months after commencing the dressing application.
Erythema level
Erythema level will be measured using Cutometer® with mexameter mode at 1, 2, 4, and 6 months after commencing the dressing application.
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.
Adverse events
Adverse events resulted from dressing application will be evaluated.
Full Information
NCT ID
NCT04997863
First Posted
August 3, 2021
Last Updated
September 20, 2021
Sponsor
Chulalongkorn University
1. Study Identification
Unique Protocol Identification Number
NCT04997863
Brief Title
Clinical Efficacy and Safety of Sericin Hydrogel Sheet Impregnated With Bird's Nest Extract
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2021 (Anticipated)
Primary Completion Date
October 31, 2022 (Anticipated)
Study Completion Date
October 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sericin hydrogel sheet impregnated with EBN extract
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo hydrogel sheet
Arm Type
Placebo Comparator
Arm Description
Apply placebo hydrogel sheet on another half of the donor site once daily for 8-12 hours per day for 6 months.
Intervention Type
Device
Intervention Name(s)
Sericin hydrogel sheet impregnated with EBN extract
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Placebo hydrogel sheet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Vancouver Scar Scale (VSS) score
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Patient and Observer Scar Assessment Scale (POSAS) score
Description
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.
Time Frame
6 months
Title
Melanin level
Description
Melanin level will be measured using Cutometer® with mexameter mode at 1, 2, 4, and 6 months after commencing the dressing application.
Time Frame
6 months
Title
Erythema level
Description
Erythema level will be measured using Cutometer® with mexameter mode at 1, 2, 4, and 6 months after commencing the dressing application.
Time Frame
6 months
Title
Transepidermal water loss (TEWL)
Description
TEWL will be measured using Cutometer® with tewameter mode at 1, 2, 4, and 6 months after commencing the dressing application.
Time Frame
6 months
Title
Adverse events
Description
Adverse events resulted from dressing application will be evaluated.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pornanong Aramwit, Ph.D
Phone
+66899217255
Email
aramwit@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pornanong Aramwit, Ph.D
Organizational Affiliation
Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn University
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Chulalongkorn Memorial Hospital
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pornanong Aramwit, Ph.D
Phone
+66899217255
Email
aramwit@gmail.com
First Name & Middle Initial & Last Name & Degree
Pornanong Aramwit, Ph.D
12. IPD Sharing Statement
Learn more about this trial
Clinical Efficacy and Safety of Sericin Hydrogel Sheet Impregnated With Bird's Nest Extract
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