Wound HealNCT04743375
Clinical Efficacy of Silk Sericin Dressing With Collagen for Split-thickness Skin Graft Donor Site Treatment
A study testing wound dressing application in people with Wound Heal and Wound Surgical, run by Chulalongkorn University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Heal, Wound Surgical, Donor Site Complication
- What is being tested?
- wound dressing application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteThailand
- Study dates
- Feb 2021to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Chulalongkorn Hospital
Bangkok, 10330
Pornanong Aramwit, Ph.D., +66-89-9217255, aramwit@gmail.com
Pornanong Aramwit, Ph.D.
About this study
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.
Read the detailed description
Wounds are a public health problem found worldwide that associated with both clinical and economic burdens. Although several wound dressings are available, some limitations of those dressings still existed resulting in the need for new wound dressing development.
The sericin dressing with collagen was developed to provide a moist environment and bioactive ingredients to the wound bed. To evaluate its efficacy and safety, the STSG donor sites of each patient will be divided into two equal areas. Each area will be randomly allocated into sericin dressing with collagen group or control group (Bactigras®). The outcomes will be collected to examine the efficacy and safety of sericin dressing with collagen in comparison with commercial dressing Bactigras®.
- Conditions
- Wound Heal, Wound Surgical, Donor Site Complication
- Being tested
- wound dressing application
- Keywords
- Wound dressing, Sericin, Collagen, Split-thickness skin graft donor site (STSG donor site)
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wound dressing applicationOther
Sericin dressing with collagen or Bactigras will be used as a primary dressing for treating the STSG donor site.
| Study group | Role | What they receive |
|---|---|---|
| Sericin dressing with collagen | Experimental | Sericin dressing with collagen Receives: Other: wound dressing application |
| Bactigras | Active comparator | Commercial dressing Receives: Other: wound dressing application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 42 days
Secondary outcomes (10)
Pain score
Pain score evaluated by patient using visual analog scales (0-10)
Measured: 42 days
Incidence of infection
The incidence of infection will be reported as "present" or "not present". Infection wound is wound which has purulent secretion or some of the inflammatory reactions (erythema, warmth, pain or tenderness, or induration) and has positive result from microbiological test.
Measured: 42 days
Incidence of adverse effect
Adverse effects on hepatic function, renal function, and other adverse effects resulted from dressing application will be reported as "present" or "not present".
Measured: 42 days
Vancouver scar scale (VSS)
Vancouver scar scale evaluated by clinician at 1, 3, and 6 months after complete wound healing
Measured: 6 months
Patient scale of Patient and observer scar scale (POSAS)
Patient scale of Patient and observer scar scale (POSAS) evaluated by patients 6 months after complete wound healing
Measured: 6 months
Erythema level
Erythema level measured by using Mexameter® at 1, 3, and 6 months after complete wound healing
Measured: 6 months
Melanin level
Melanin level measured by using Mexameter® at 1, 3, and 6 months after complete wound healing
Measured: 6 months
Trans-epidermal water loss (TEWL)
TEWL measured by using Tewameter® at 1, 3, and 6 months after complete wound healing
Measured: 6 months
Skin hydration
Hydration level measured by using Corneometer® at 1, 3, and 6 months after complete wound healing
Measured: 6 months
Skin elasticity
Elasticity parameters measured by using Cutometer® at 1, 3, and 6 months after complete wound healing
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study startFeb 2021 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pornanong Aramwit, Pharm.D., Ph.D, Chulalongkorn University
- Investigators
- Pornanong Aramwit, Ph.D, Principal investigator, Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04743375
- Sponsor's protocol ID
- Med Chula IRB 143/63
- Status last verified
- Feb 2021
- First submitted
- 4 Feb 2021
- Last updated
- 8 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Silk Sericin Dressing With Collagen for Split-thickness Skin Graft Donor Site Treatment
- ClinicalTrials.gov ID
- NCT04743375
- Acronym / sponsor ID
- Med Chula IRB 143/63
- Conditions
- Wound Heal, Wound Surgical, Donor Site Complication
- Keywords
- Wound dressing, Sericin, Collagen, Split-thickness skin graft donor site (STSG donor site)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Feb 2021 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 8 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Wounds are a public health problem found worldwide that associated with both clinical and economic burdens. Although several wound dressings are available, some limitations of those dressings still existed resulting in the need for new wound dressing development.
The sericin dressing with collagen was developed to provide a moist environment and bioactive ingredients to the wound bed. To evaluate its efficacy and safety, the STSG donor sites of each patient will be divided into two equal areas. Each area will be randomly allocated into sericin dressing with collagen group or control group (Bactigras®). The outcomes will be collected to examine the efficacy and safety of sericin dressing with collagen in comparison with commercial dressing Bactigras®.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sericin dressing with collagen | Experimental | Other: wound dressing applicationSericin dressing with collagen |
| Bactigras | Active comparator | Other: wound dressing applicationCommercial dressing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| wound dressing applicationSericin dressing with collagen or Bactigras will be used as a primary dressing for treating the STSG donor site. | Other | Bactigras, Sericin dressing with collagen |
Primary outcome
Time to complete healing
Time frame: 42 days
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.
10 secondary outcomes
Pain score
Time frame: 42 days
Incidence of infection
Time frame: 42 days
Incidence of adverse effect
Time frame: 42 days
Vancouver scar scale (VSS)
Time frame: 6 months
Patient scale of Patient and observer scar scale (POSAS)
Time frame: 6 months
Erythema level
Time frame: 6 months
Melanin level
Time frame: 6 months
Trans-epidermal water loss (TEWL)
Time frame: 6 months
Skin hydration
Time frame: 6 months
Skin elasticity
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
Related trials for Wound Heal
Active, not recruiting
EDX110 Randomized Control Trial for Treatment of DFUs
Wound Heal, Diabetic Foot Ulcer
Not yet recruitingPhase 1
Amnion Membrane Powder Mohs Study
Wound Heal
Active, not recruiting
IDEAL: Efficacy of Porcine Placental Extracellular Matrix Augmented Plus Standard of Care (SOC) Versus SOC Alone for the Management of Diabetic Foot Ulcers
Wound Heal, Ulcer
Active, not recruitingPhase 2
Guselkumab in the Treatment of Adults With Pyoderma Gangrenosum (PG)
Pyoderma Gangrenosum, Skin Diseases
Recruiting
Clinical Investigation of Sorbact® Dressings
Hard-to-heal Wounds, Diabetic Foot Ulcer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pornanong Aramwit, Ph.D principal investigator
Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wound dressing application in people with Wound Heal and Wound Surgical, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pornanong Aramwit, Ph.D (+66899217255, aramwit@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to complete healing (time frame: 42 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2021; AzTrials last refreshed its copy on 6 Nov 2026.