Late Complication From Skin GraftPhase 1/2NCT02091076
Efficacy and Safety of Silk Fibroin With Bioactive Coating Layer Dressing
A Phase 1/2 study testing Silk fibroin with bioactive coating layer dressing and Bactigras wound dressing in people with Late Complication From Skin Graft and Infection of Skin Donor Site, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
A split-thickness skin graft (STSG) is used for a large wounds or wounds that cannot be closed by primary and secondary wound closure. Accelerated re-epithelialization rate and minimizing pain and infection are main goals of donor care. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Late Complication From Skin Graft, Infection of Skin Donor Site, Impaired Wound Healing
- What is being tested?
- Silk fibroin with bioactive coating layer dressing and Bactigras wound dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2014to May 2015
- Phase
- Phase 1/2
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients age 18 to 60 years.
- Patients have to undergo a split thickness skin graft.
- The donor sites of split-thickness skin graft locate on the thigh.
- Patients consent to participate in this study.
Who cannot join
- Donor sites are anywhere else than the thigh area.
- Patients are allergic to silk sericin or silk fibroin or paraffin or chlorhexidine acetate.
- There is a risk of transferring an infection from a nearby infected area to donor site such as acute burn patients.
- Immunocompromised patients such as with acquired immunodeficiency syndrome (AIDS) and renal failure.
- Patients with diabetes mellitus.
- Patients with low serum albumin level (less than 3.0 g/dL)
Show all 9Show fewer
- Patients have psychiatric disorders or patients with physical disabilities that hinders collaboration.
- Patients who do not comply with the study protocol.
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Wound Dressing Containing Silk Fibroin With Bioactive Coating Layer Versus Medicated Paraffin Gauze Dressing in the Treatment of Split-thickness Skin Graft Donor Sites
A split-thickness skin graft (STSG) is used for a large wounds or wounds that cannot be closed by primary and secondary wound closure. Accelerated re-epithelialization rate and minimizing pain and infection are main goals of donor care. Traditionally dressings are inexpensive but adhere to the wound surface and cannot absorb exudates. Thus, we have developed a new biomaterial based on Thai silk for wound dressing application. Silk fibroin and silk sericin were selected to produce wound dressing in this study. The objective of this study is to compare wound dressing containing silk fibroin with bioactive coating layer with standard dressing (medicated paraffin gauze dressing; Bactigras®), with regard to healing time, patients' pain intensity, skin's transepidermal water loss after healing and evidence of infection in the treatment of split-thickness skin graft donor sites. The study design is a randomized, controlled, self paired clinical trial. Patients age 18 to 60 years and undergo STSG at thigh in Department of Surgery, King Chulalongkorn Memorial Hospital will be recruited in the study. The exclusion criteria are donor sites other than thigh area or located at high risk of infection. Patients who are immunocompromised or diabetes mellitus or psychiatric disorders or low serum albumin level (less than 3.0 g/dL) or known allergic to SS or SF or paraffin or chlorhexidine acetate are also excluded. All subjects sign the informed consents after discussion the protocol, benefits and risks. The donor site will be divided into two equal halves, each site will be randomized to receive the tested material or the medicated paraffin gauze dressing. The donor site wounds will be observed daily. The dressings will not be changed, except when they are fully soaked with exudates and easily fell off or any sign of infection. Healing time will be recorded when the dressing separate completely from the donor site, no exudates and no pain when the donor site is exposed to air. The patient's pain level will be evaluated with the visual analogue scale and the donor site wounds will be observed daily for signs of infection. On the day of the wound is recorded for healing time and 1 weeks, 1, 2, 3, 4 and 5 months after that, the skin barrier function (TEWL) of each site will be measured using a Tewameter. Blood sample will be collected from patients pre- and postoperatively (within day 3) for hepatic and renal function analysis.
Read the detailed description
- To compare the healing times of the split-thickness skin graft donor site under wound dressing containing silk fibroin woven fabric with bioactive coating layer and medicated paraffin gauze dressing.
- To compare the patients' pain levels of the split-thickness skin graft donor site under wound dressing containing silk fibroin woven fabric with bioactive coating layer and medicated paraffin gauze dressing.
- To compare the chance of infections of the split-thickness skin graft donor site under wound dressing containing silk fibroin woven fabric with bioactive coating layer and medicated paraffin gauze dressing.
- To determine the complications with the use of wound dressing containing silk fibroin woven fabric with bioactive coating layer.
- Conditions
- Late Complication From Skin Graft, Infection of Skin Donor Site, Impaired Wound Healing, Pain, Intractable
- Being tested
- Silk fibroin with bioactive coating layer dressing, Bactigras wound dressing
- Keywords
- Silk fibroin with bioactive coating layer dressing, Wound healing, Skin graft donor
- Medical subject headings
- Pain, Intractable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silk fibroin with bioactive coating layer dressingDevice
Bactigras wound dressingDevice
| Study group | Role | What they receive |
|---|---|---|
| Silk with bioactive coated dressing | Experimental | Silk fibroin coated with bioactive layer, apply once only Receives: Device: Silk fibroin with bioactive coating layer dressing |
| Control | Active comparator | Bactigras wound dressing, apply once only Receives: Device: Bactigras wound dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical efficacy of of wound dressing containing silk fibroin with bioactive coating layer dressing in the treatment of split-thickness skin graft donor sites
Time for complete epithalization is duration between finishing surgical procedure and the dressing spontaneously peeling off from donor sites without causing pain. The wounds completely close and without fluid leakage and are able to exposed to the environment without pain. This duration should not exceed than 14 days.
Measured: Within 14 days after operation
Secondary outcomes (1)
Clinical safety of wound dressing containing silk fibroin with bioactive coating layer dressing in the treatment of split-thickness skin graft donor sites
Percentage of wound infection
Measured: Within 14 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Late Complication From Skin GraftStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02091076
- Sponsor's protocol ID
- Chula-53-1
- Status last verified
- Nov 2016
- First submitted
- 14 Mar 2014
- Last updated
- 3 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Wound Dressing Containing Silk Fibroin With Bioactive Coating Layer Versus Medicated Paraffin Gauze Dressing in the Treatment of Split-thickness Skin Graft Donor Sites
- ClinicalTrials.gov ID
- NCT02091076
- Acronym / sponsor ID
- Chula-53-1
- Conditions
- Late Complication From Skin Graft, Infection of Skin Donor Site, Impaired Wound Healing, Pain, Intractable
- Keywords
- Silk fibroin with bioactive coating layer dressing, Wound healing, Skin graft donor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 19 Mar 2014 (estimated)
- 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.
A split-thickness skin graft (STSG) is used for a large wounds or wounds that cannot be closed by primary and secondary wound closure. Accelerated re-epithelialization rate and minimizing pain and infection are main goals of donor care. Traditionally dressings are inexpensive but adhere to the wound surface and cannot absorb exudates. Thus, we have developed a new biomaterial based on Thai silk for wound dressing application. Silk fibroin and silk sericin were selected to produce wound dressing in this study. The objective of this study is to compare wound dressing containing silk fibroin with bioactive coating layer with standard dressing (medicated paraffin gauze dressing; Bactigras®), with regard to healing time, patients' pain intensity, skin's transepidermal water loss after healing and evidence of infection in the treatment of split-thickness skin graft donor sites. The study design is a randomized, controlled, self paired clinical trial. Patients age 18 to 60 years and undergo STSG at thigh in Department of Surgery, King Chulalongkorn Memorial Hospital will be recruited in the study. The exclusion criteria are donor sites other than thigh area or located at high risk of infection. Patients who are immunocompromised or diabetes mellitus or psychiatric disorders or low serum albumin level (less than 3.0 g/dL) or known allergic to SS or SF or paraffin or chlorhexidine acetate are also excluded. All subjects sign the informed consents after discussion the protocol, benefits and risks. The donor site will be divided into two equal halves, each site will be randomized to receive the tested material or the medicated paraffin gauze dressing. The donor site wounds will be observed daily. The dressings will not be changed, except when they are fully soaked with exudates and easily fell off or any sign of infection. Healing time will be recorded when the dressing separate completely from the donor site, no exudates and no pain when the donor site is exposed to air. The patient's pain level will be evaluated with the visual analogue scale and the donor site wounds will be observed daily for signs of infection. On the day of the wound is recorded for healing time and 1 weeks, 1, 2, 3, 4 and 5 months after that, the skin barrier function (TEWL) of each site will be measured using a Tewameter. Blood sample will be collected from patients pre- and postoperatively (within day 3) for hepatic and renal function analysis.
Detailed description
- To compare the healing times of the split-thickness skin graft donor site under wound dressing containing silk fibroin woven fabric with bioactive coating layer and medicated paraffin gauze dressing.
- To compare the patients' pain levels of the split-thickness skin graft donor site under wound dressing containing silk fibroin woven fabric with bioactive coating layer and medicated paraffin gauze dressing.
- To compare the chance of infections of the split-thickness skin graft donor site under wound dressing containing silk fibroin woven fabric with bioactive coating layer and medicated paraffin gauze dressing.
- To determine the complications with the use of wound dressing containing silk fibroin woven fabric with bioactive coating layer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silk with bioactive coated dressing | Experimental | Device: Silk fibroin with bioactive coating layer dressingSilk fibroin coated with bioactive layer, apply once only |
| Control | Active comparator | Device: Bactigras wound dressingBactigras wound dressing, apply once only |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients age 18 to 60 years.
- Patients have to undergo a split thickness skin graft.
- The donor sites of split-thickness skin graft locate on the thigh.
- Patients consent to participate in this study.
Key exclusion criteria (9 listed)
- Donor sites are anywhere else than the thigh area.
- Patients are allergic to silk sericin or silk fibroin or paraffin or chlorhexidine acetate.
- There is a risk of transferring an infection from a nearby infected area to donor site such as acute burn patients.
- Immunocompromised patients such as with acquired immunodeficiency syndrome (AIDS) and renal failure.
- Patients with diabetes mellitus.
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 |
|---|---|---|
| Silk fibroin with bioactive coating layer dressing | Device | Silk with bioactive coated dressing |
| Bactigras wound dressing | Device | Control |
Primary outcome
Clinical efficacy of of wound dressing containing silk fibroin with bioactive coating layer dressing in the treatment of split-thickness skin graft donor sites
Time frame: Within 14 days after operation
Time for complete epithalization is duration between finishing surgical procedure and the dressing spontaneously peeling off from donor sites without causing pain. The wounds completely close and without fluid leakage and are able to exposed to the environment without pain. This duration should not exceed than 14 days.
1 secondary outcome
Clinical safety of wound dressing containing silk fibroin with bioactive coating layer dressing in the treatment of split-thickness skin graft donor sites
Time frame: Within 14 days after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2016.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Silk fibroin with bioactive coating layer dressing and Bactigras wound dressing in people with Late Complication From Skin Graft and Infection of Skin Donor Site, 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 3 Nov 2016. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical efficacy of of wound dressing containing silk fibroin with bioactive coating layer dressing in the treatment of split-thickness skin graft donor sites (time frame: Within 14 days after operation). 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 3 Nov 2016.