Second-degree BurnNCT03048188
Manuka Honey in Second- and Grafted Third-degree Burns
A study testing wound dressing in people with Second-degree Burn and Third-Degree Burn, run by University Hospital Schleswig-Holstein at 2 sites in Germany.
Trial summary
Treatment strategies of II. degree burn wounds and split-skin grafted III. degree burn wounds aim at reducing infection and improving reepithelialization. The aim of this study is to evaluate time to reepithelialization, pain, microbiology and handling of manuka honey dressings with second-degree burn wounds and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Second-degree Burn, Third-Degree Burn
- What is being tested?
- wound dressing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesGermany
- Study dates
- 15 Jul 2015to Dec 2023
- 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
- Consent-capable male and female patients (or guardian)
- ≥18 years of age
- ability to asses pain
Who cannot join
- Immunosuppressive Therapy
- Clinical wound infection
- Allergy against honey
- Relationship to someone who is involved in the study design or assessment
- Participation in other clinical trials
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 1 recruiting
- Completed
University Hospital Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23538
- Recruiting
University of Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23538
Tobias Kisch, MD, 00494515002063, tobias.kisch@uni-luebeck.de
About this study
Official title: Clinical Application Observation of Manuka Honey in Second- and Grafted Third-degree Burns
Treatment strategies of II. degree burn wounds and split-skin grafted III. degree burn wounds aim at reducing infection and improving reepithelialization. The aim of this study is to evaluate time to reepithelialization, pain, microbiology and handling of manuka honey dressings with second-degree burn wounds and split-skin grafted burn wounds.
Read the detailed description
In plastic and reconstructive surgery, treatment strategies of second-degree burn wounds and split-skin grafted third-degree burn wounds aim at reducing infection and improving reepithelialization. Although previous studies indicate that burn patients benefit from wound dressings containing manuka honey, only a few studies can be found. Therefore, the aim of this study is to evaluate time to reepithelialization, pain, microbiology and handling of manuka honey dressings with second-degree burn wounds and split-skin grafted burn wounds.
- Conditions
- Second-degree Burn, Third-Degree Burn
- Being tested
- wound dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wound dressingOther
Manuka honey wound dressing
| Study group | Role | What they receive |
|---|---|---|
| Burn with or without split-skin graft | Experimental | Second degree burns and third degree burns with split-skin graft that need wound dressings Receives: Other: wound dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epithelialization
Rate of Epithelialization in percent
Measured: Up to 1 year
Secondary outcomes (3)
Pain
Visual analog scale (VAS)
Measured: Up to 1 year
Microbiology
Microbiological smear is assessed by gram+, gram- or no bacterium
Measured: Up to 1 year
Handling
Scale (0-4)
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start15 Jul 2015
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Second-degree BurnStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Collaborators
- University of Luebeck
- Responsible party
- Principal investigator, Tobias Kisch, University Hospital Schleswig-Holstein
- Investigators
- Tobias Kisch, MD, Principal investigator, University of Lübeck, University Hospital Schleswig-Holstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03048188
- Sponsor's protocol ID
- 14-265
- Status last verified
- Feb 2023
- First submitted
- 28 Jan 2017
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application Observation of Manuka Honey in Second- and Grafted Third-degree Burns
- ClinicalTrials.gov ID
- NCT03048188
- Acronym / sponsor ID
- 14-265
- Conditions
- Second-degree Burn, Third-Degree Burn
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Collaborators
- University of Luebeck
- Study start
- 15 Jul 2015 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 9 Feb 2017 (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.
Treatment strategies of II. degree burn wounds and split-skin grafted III. degree burn wounds aim at reducing infection and improving reepithelialization. The aim of this study is to evaluate time to reepithelialization, pain, microbiology and handling of manuka honey dressings with second-degree burn wounds and split-skin grafted burn wounds.
Detailed description
In plastic and reconstructive surgery, treatment strategies of second-degree burn wounds and split-skin grafted third-degree burn wounds aim at reducing infection and improving reepithelialization. Although previous studies indicate that burn patients benefit from wound dressings containing manuka honey, only a few studies can be found. Therefore, the aim of this study is to evaluate time to reepithelialization, pain, microbiology and handling of manuka honey dressings with second-degree burn wounds and split-skin grafted burn wounds.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Burn with or without split-skin graft | Experimental | Other: wound dressingSecond degree burns and third degree burns with split-skin graft that need wound dressings |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Consent-capable male and female patients (or guardian)
- ≥18 years of age
- ability to asses pain
Key exclusion criteria (5 listed)
- Immunosuppressive Therapy
- Clinical wound infection
- Allergy against honey
- Relationship to someone who is involved in the study design or assessment
- Participation in other clinical trials
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 dressingManuka honey wound dressing | Other | Burn with or without split-skin graft |
Primary outcome
Epithelialization
Time frame: Up to 1 year
Rate of Epithelialization in percent
3 secondary outcomes
Pain
Time frame: Up to 1 year
Microbiology
Time frame: Up to 1 year
Handling
Time frame: Up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
- 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.
Tobias Kisch, MD principal investigator
University of Lübeck, University Hospital Schleswig-Holstein
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wound dressing in people with Second-degree Burn and Third-Degree Burn, run by University Hospital Schleswig-Holstein at 2 sites in Germany.
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 3 inclusion and 5 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 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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 Tobias Kisch, MD (00494515000, tobias.kisch@uni-luebeck.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epithelialization (time frame: Up to 1 year). 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 24 Feb 2023.