- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04997863
Clinical Efficacy and Safety of Sericin Hydrogel Sheet Impregnated With Bird's Nest Extract
September 20, 2021 updated by: Pornanong Aramwit, Pharm.D., Ph.D, Chulalongkorn University
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
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.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Pornanong Aramwit, Ph.D
- Phone Number: +66899217255
- Email: aramwit@gmail.com
Study Locations
-
-
-
Bangkok, Thailand, 10330
- King Chulalongkorn Memorial Hospital
-
Contact:
- Pornanong Aramwit, Ph.D
- Phone Number: +66899217255
- Email: aramwit@gmail.com
-
Principal Investigator:
- Pornanong Aramwit, Ph.D
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sericin hydrogel sheet impregnated with EBN extract
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.
|
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 Comparator: Placebo hydrogel sheet
Apply placebo hydrogel sheet on another half of the donor site once daily for 8-12 hours per day for 6 months.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vancouver Scar Scale (VSS) score
Time Frame: 6 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient and Observer Scar Assessment Scale (POSAS) score
Time Frame: 6 months
|
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
|
Melanin level
Time Frame: 6 months
|
Melanin level will be measured using Cutometer® with mexameter mode at 1, 2, 4, and 6 months after commencing the dressing application.
|
6 months
|
Erythema level
Time Frame: 6 months
|
Erythema level will be measured using Cutometer® with mexameter mode at 1, 2, 4, and 6 months after commencing the dressing application.
|
6 months
|
Transepidermal water loss (TEWL)
Time Frame: 6 months
|
TEWL will be measured using Cutometer® with tewameter mode at 1, 2, 4, and 6 months after commencing the dressing application.
|
6 months
|
Adverse events
Time Frame: 6 months
|
Adverse events resulted from dressing application will be evaluated.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Pornanong Aramwit, Ph.D, Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
November 1, 2021
Primary Completion (Anticipated)
October 31, 2022
Study Completion (Anticipated)
October 31, 2022
Study Registration Dates
First Submitted
August 3, 2021
First Submitted That Met QC Criteria
August 3, 2021
First Posted (Actual)
August 10, 2021
Study Record Updates
Last Update Posted (Actual)
September 24, 2021
Last Update Submitted That Met QC Criteria
September 20, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Med Chula IRB 572/64
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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