Clinical Efficacy and Safety of Sericin Hydrogel Sheet Impregnated With Bird's Nest Extract
20. september 2021 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Forventet)
30
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Pornanong Aramwit, Ph.D
- Telefonnummer: +66899217255
- E-post: aramwit@gmail.com
Studiesteder
-
-
-
Bangkok, Thailand, 10330
- King Chulalongkorn Memorial Hospital
-
Ta kontakt med:
- Pornanong Aramwit, Ph.D
- Telefonnummer: +66899217255
- E-post: aramwit@gmail.com
-
Hovedetterforsker:
- Pornanong Aramwit, Ph.D
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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 komparator: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Vancouver Scar Scale (VSS) score
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Patient and Observer Scar Assessment Scale (POSAS) score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 6 months
|
Adverse events resulted from dressing application will be evaluated.
|
6 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Pornanong Aramwit, Ph.D, Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Forventet)
1. november 2021
Primær fullføring (Forventet)
31. oktober 2022
Studiet fullført (Forventet)
31. oktober 2022
Datoer for studieregistrering
Først innsendt
3. august 2021
Først innsendt som oppfylte QC-kriteriene
3. august 2021
Først lagt ut (Faktiske)
10. august 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. september 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
20. september 2021
Sist bekreftet
1. september 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Med Chula IRB 572/64
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .