BurnNCT03279549
Research on the Key Technology of Burn Wound Treatment
A study testing Routine dressing change, Limited debridement & Acellular dermal matrix dressing and Limited debridement & Epidermal cell spraying in people with Burn, run by Xijing Hospital.
Trial summary
Burns are common injuries in the daily life and wars. With the development of medical techniques, the mortality has been significantly reduced. However, the deformity and disability caused by hypertrophic scar have not been improved effectively since the wound repair technology is limited and controversial, especially… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Burn
- What is being tested?
- Routine dressing change, Limited debridement & Acellular dermal matrix dressing and Limited debridement & Epidermal cell spraying
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2018to 30 Sep 2019
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Area of deep second burn wound >=10cm×10cm，total burn area ≤50% TBSA.
- Within 96 hours after burns and could be managed within 24 hours after included.
- Ages from 18 to 60.
- No serious breathing, circulation and other systemic diseases, no surgical contraindications.
- Agrees to participate in this trial and has signed an informed consent form.
Who cannot join
- Have severe inhalation injury or shock, or acute respiratory failure；
- There are serious heart (especially the recent myocardial infarction, myocardial damage, etc.), brain, liver, kidney, lung and other organ disease;
- Susceptible to allergies；
- Islamic believers
- Pregnant women
- Other cases that are not suitable for study
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized, Controlled, Prospective Clinical Trial on the Key Technology of Burn Wound Treatment
Burns are common injuries in the daily life and wars. With the development of medical techniques, the mortality has been significantly reduced. However, the deformity and disability caused by hypertrophic scar have not been improved effectively since the wound repair technology is limited and controversial, especially on the early treatment of deep second degree burns. The prognosis of burns is of great difference. In recent years, the promotion of wound repairing technologies provides a new opportunity for improving the quality of wound healing and solving the problem of scar formation. Although some new methods and techniques have shown significant efficacy in clinic, clinical researches with large samples conducted in multiple centers are still deficient, impeding the evaluation of their superiority. Therefore, the current protocol focuses on the repair of deep second degree burns based on previous researches. There are four types of treatment protocols for wounds. Patients were divided into four groups randomly, including regular dressing change group, controlled debridement + biological dressing covering group (xenogeneic acellular dermal matrix), controlled debridement + epidermal cell cultivation group, controlled debridement + bFGF treatment group. The wound healing rate, healing time and scar formation were observed. The availability and security were evaluated. Further more, treatment guidelines and expert consensuses on deep second degree burn wounds were concluded. Above studies are important to promote the treatment of deep second degree burns to be scientific, standardized and professional in China.
- Conditions
- Burn
- Being tested
- Routine dressing change, Limited debridement & Acellular dermal matrix dressing, Limited debridement & Epidermal cell spraying, Limited debridement & Basic fibroblast growth factor
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine dressing changeProcedure or surgery
Through regular dressing changes to clean the wound, reduce bacterial growth in the wound and protect the wound. In recent years, nano-silver ion gel and dressings are widely used in burns, which effectively reduced the risk of wound infection and beneficial for wound healing. This technique is widely used in clinic.
Limited debridement & Acellular dermal matrix dressingProcedure or surgery
In the removal of necrotic dermis in the "rather not deep" principle, as far as possible not damage the normal dermal tissue and skin accessories. This could improve circulation of wounds and improve wound healing. The xenogeneic acellular dermal matrix dressing has a better protective effect on burn wound after debridement. After covering, the wound will remain alive for about two weeks, providing a good microenvironment for wound repair.
Limited debridement & Epidermal cell sprayingProcedure or surgery
In the removal of necrotic dermis in the "rather not deep" principle, as far as possible not damage the normal dermal tissue and skin accessories. This could improve circulation of wounds and improve wound healing. Epidermal cell spraying technology is a brand new method to rapidly collect epidermal cells from patients themselves and then used on their wounds. The recipient site is 40-80 times than the donor site.
Limited debridement & Basic fibroblast growth factorProcedure or surgery
In the removal of necrotic dermis in the "rather not deep" principle, as far as possible not damage the normal dermal tissue and skin accessories. This could improve circulation of wounds and improve wound healing. BFGF is a kind of polypeptide capable of promoting the growth of fibroblasts, and it also promotes the proliferation, differentiation and migration of epidermal cells. Studies have shown that bFGF could significantly improve the healing of burn wounds.
| Study group | Role | What they receive |
|---|---|---|
| dressing change group | Active comparator | Routine dressing change group Receives: Procedure: Routine dressing change |
| Dermal matrix dressing group | Experimental | Limited debridement \& Acellular dermal matrix dressing group. Receives: Procedure: Limited debridement & Acellular dermal matrix dressing |
| Epidermal cell spraying group | Experimental | Limited debridement \& Epidermal cell spraying group Receives: Procedure: Limited debridement & Epidermal cell spraying |
| BFGF group | Experimental | Limited debridement \& Basic fibroblast growth factor group Receives: Procedure: Limited debridement & Basic fibroblast growth factor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing time
Healing time is the number of days when the wound healed completely after management.
Measured: 21 days after treatment
Secondary outcomes (2)
Wound healing rate
Wound healing rate =（area before management - area after management）/ area before management×100%.
Measured: 21 days after treatment
Scar formation
Vancouver scar score
Measured: 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start1 Jul 2018 (estimated)
- Primary completion31 Dec 2018 (estimated)
- Study completion30 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe 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
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Jishuitan Hospital, First Hospitals affiliated to the China PLA General Hospital, Ruijin Hospital, Southwest Hospital, China, Second Affiliated Hospital, Zhejiang University, School of Medicine, Xiangya Hospital of Central South University
- Responsible party
- Principal investigator, Hu Dahai, Xijing Hospital
- Investigators
- Xie Songtao, Doctor, Principal investigator, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03279549
- Sponsor's protocol ID
- KY20140709-1
- Status last verified
- Jun 2018
- First submitted
- 5 Sep 2017
- Last updated
- 27 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Prospective Clinical Trial on the Key Technology of Burn Wound Treatment
- ClinicalTrials.gov ID
- NCT03279549
- Acronym / sponsor ID
- KY20140709-1
- Conditions
- Burn
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Collaborators
- Beijing Jishuitan Hospital, First Hospitals affiliated to the China PLA General Hospital, Ruijin Hospital, Southwest Hospital, China, Second Affiliated Hospital, Zhejiang University, School of Medicine, Xiangya Hospital of Central South University
- Study start
- 1 Jul 2018 (estimated)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 12 Sep 2017 (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.
Burns are common injuries in the daily life and wars. With the development of medical techniques, the mortality has been significantly reduced. However, the deformity and disability caused by hypertrophic scar have not been improved effectively since the wound repair technology is limited and controversial, especially on the early treatment of deep second degree burns. The prognosis of burns is of great difference. In recent years, the promotion of wound repairing technologies provides a new opportunity for improving the quality of wound healing and solving the problem of scar formation. Although some new methods and techniques have shown significant efficacy in clinic, clinical researches with large samples conducted in multiple centers are still deficient, impeding the evaluation of their superiority. Therefore, the current protocol focuses on the repair of deep second degree burns based on previous researches. There are four types of treatment protocols for wounds. Patients were divided into four groups randomly, including regular dressing change group, controlled debridement + biological dressing covering group (xenogeneic acellular dermal matrix), controlled debridement + epidermal cell cultivation group, controlled debridement + bFGF treatment group. The wound healing rate, healing time and scar formation were observed. The availability and security were evaluated. Further more, treatment guidelines and expert consensuses on deep second degree burn wounds were concluded. Above studies are important to promote the treatment of deep second degree burns to be scientific, standardized and professional in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| dressing change group | Active comparator | Procedure: Routine dressing changeRoutine dressing change group |
| Dermal matrix dressing group | Experimental | Procedure: Limited debridement & Acellular dermal matrix dressingLimited debridement \& Acellular dermal matrix dressing group. |
| Epidermal cell spraying group | Experimental | Procedure: Limited debridement & Epidermal cell sprayingLimited debridement \& Epidermal cell spraying group |
| BFGF group | Experimental | Procedure: Limited debridement & Basic fibroblast growth factorLimited debridement \& Basic fibroblast growth factor group |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Area of deep second burn wound >=10cm×10cm，total burn area ≤50% TBSA.
- Within 96 hours after burns and could be managed within 24 hours after included.
- Ages from 18 to 60.
- No serious breathing, circulation and other systemic diseases, no surgical contraindications.
- Agrees to participate in this trial and has signed an informed consent form.
Key exclusion criteria (6 listed)
- Have severe inhalation injury or shock, or acute respiratory failure；
- There are serious heart (especially the recent myocardial infarction, myocardial damage, etc.), brain, liver, kidney, lung and other organ disease;
- Susceptible to allergies；
- Islamic believers
- Pregnant women
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 |
|---|---|---|
| Routine dressing changeThrough regular dressing changes to clean the wound, reduce bacterial growth in the wound and protect the wound. In recent years, nano-silver ion gel and dressings are widely used in burns, which effectively reduced the risk of wound infection and beneficial for wound healing. This technique is widely used in clinic. | Procedure or surgery | dressing change group |
| Limited debridement & Acellular dermal matrix dressingIn the removal of necrotic dermis in the "rather not deep" principle, as far as possible not damage the normal dermal tissue and skin accessories. This could improve circulation of wounds and improve wound healing. The xenogeneic acellular dermal matrix dressing has a better protective effect on burn wound after debridement. After covering, the wound will remain alive for about two weeks, providing a good microenvironment for wound repair. | Procedure or surgery | Dermal matrix dressing group |
| Limited debridement & Epidermal cell sprayingIn the removal of necrotic dermis in the "rather not deep" principle, as far as possible not damage the normal dermal tissue and skin accessories. This could improve circulation of wounds and improve wound healing. Epidermal cell spraying technology is a brand new method to rapidly collect epidermal cells from patients themselves and then used on their wounds. The recipient site is 40-80 times than the donor site. | Procedure or surgery | Epidermal cell spraying group |
| Limited debridement & Basic fibroblast growth factorIn the removal of necrotic dermis in the "rather not deep" principle, as far as possible not damage the normal dermal tissue and skin accessories. This could improve circulation of wounds and improve wound healing. BFGF is a kind of polypeptide capable of promoting the growth of fibroblasts, and it also promotes the proliferation, differentiation and migration of epidermal cells. Studies have shown that bFGF could significantly improve the healing of burn wounds. | Procedure or surgery | BFGF group |
Primary outcome
Wound healing time
Time frame: 21 days after treatment
Healing time is the number of days when the wound healed completely after management.
2 secondary outcomes
Wound healing rate
Time frame: 21 days after treatment
Scar formation
Time frame: 6 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
- Individual participant dataSharing planned: No
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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.
Xie Songtao, Doctor principal investigator
Xijing Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Routine dressing change, Limited debridement & Acellular dermal matrix dressing and Limited debridement & Epidermal cell spraying in people with Burn, run by Xijing Hospital.
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 6 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 27 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Hu Dahai, Doctor (029-84775293, hudhai@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing time (time frame: 21 days after treatment). 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 27 Jun 2018; AzTrials last refreshed its copy on 7 Nov 2026.