Clinical Efficacy of Silk Sericin Dressing With Collagen for Split-thickness Skin Graft Donor Site Treatment
1 other identifier
interventional
30
1 country
1
Brief Summary
To examine the efficacy and safety of sericin dressing with collagen in STSG donor site treatment comparing with Bactigras®. Around 30 patients will be enrolled in this study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2021
CompletedFirst Submitted
Initial submission to the registry
February 4, 2021
CompletedFirst Posted
Study publicly available on registry
February 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedFebruary 8, 2021
February 1, 2021
5 months
February 4, 2021
February 4, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to complete healing
The number of days since starting treatment until the primary dressing can spontaneously detach from wound with full re-epithelialization (at least 95% re-epithelialization) without any drainage.
42 days
Secondary Outcomes (10)
Pain score
42 days
Incidence of infection
42 days
Incidence of adverse effect
42 days
Vancouver scar scale (VSS)
6 months
Patient scale of Patient and observer scar scale (POSAS)
6 months
- +5 more secondary outcomes
Study Arms (2)
Sericin dressing with collagen
EXPERIMENTALSericin dressing with collagen
Bactigras
ACTIVE COMPARATORCommercial dressing
Interventions
Sericin dressing with collagen or Bactigras will be used as a primary dressing for treating the STSG donor site.
Eligibility Criteria
You may qualify if:
- Patients who have STSG donor site wounds on the thigh area
- Age more than 18 years old
- The split-thickness skin graft is harvested for the first time at the investigated area.
- Patients who are able to communicate with the Thai language
- Willingness to participate
You may not qualify if:
- Patient with a mental disorder or immunocompromised diseases
- Patients who cannot or not willing to follow the protocol
- Known sensitivity or allergy to sericin, chlorhexidine, and collagen
- Pregnancy or lactation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chulalongkorn Hospital
Bangkok, 10330, Thailand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pornanong Aramwit, Ph.D
Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 4, 2021
First Posted
February 8, 2021
Study Start
February 1, 2021
Primary Completion
July 1, 2021
Study Completion
December 1, 2021
Last Updated
February 8, 2021
Record last verified: 2021-02