Split-skin Grafted Third-degree Burn WoundNCT03674151
Trial of Different Wound Dressings in Split-skin Grafted Third Degree Burns
A study testing Silver Nylon dressing, Manuka-Honey and Povidone-Iod (PVP-Iod) in people with Split-skin Grafted Third-degree Burn Wound, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Split-skin Grafted Third-degree Burn Wound
- What is being tested?
- Silver Nylon dressing, Manuka-Honey and Povidone-Iod (PVP-Iod)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2015to Dec 2025
- 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
- ≥18 years of age
- ≥3% and ≤30% total body surface area (TBSA) split-skin grafted third-degree burn
- appropriate form of wound (not: too small) and localization (not: face, inplane surface)
- ability to asses pain
Who cannot join
- Immunosuppressive Therapy
- Clinical wound infection
- Allergy against porcine material, bee poison or honey, etherial oil, propyleneglycol, silver, nylon
- Relationship to someone who is involved in the study design or assessment
- Participation in other clinical trials
- Citizen of countries outside Europe
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23538
Tobias Kisch, MD, 00494515003580, tobias.kisch@uni-luebeck.de
About this study
Official title: Randomized-controlled Trial of Wound Healing, Pain, Microbiology, Handling and Thrift of Different Wound Dressings in Patients With Split-skin Grafted Third Degree Burns
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 newer wound dressings, only a few studies comparing different wound dressings can be found. Therefore, the aim of this study is to evaluate time to reepithelialization, pain, microbiology, handling and costs of different wound dressings in patients with split-skin grafted third-degree burn wounds.
Read the detailed description
In the treatment of burn wounds polyhexanide and betaisodona (PVP-Iod) are regularly used today. They act as antiseptics, but both have drawbacks. Polyhexanide evaporates fast and therefore cools patients when applied to a large wound area. Moreover, it is known to reveal a gap for pseudomonas. On the other hand, the half-life of Betaisodona (PVP-Iod) ranges between several minutes and 12 hours. Further, its application causes intense pain, and it is cytotoxic. Other wound dressings involving silver are frequently used, too. However, they color the wounds, which might therefore not be properly assessed. Silver is also thought to be cytotoxic.
New innovations are available today. In wound dressings with bound Silver ions wounds are not colored. Hydrolytic membranes keep the level of acidity low (acidic) and have therefore antiseptic effects that last until epithelialization of a second-degree burn wounds is completed. Medical honey is used in the treatment of chronic wounds and especially in pediatric surgery and oncology. Manuka honey from New Zealand is sterilized before application and is known to be less painful for the patient. Due to its acidic effect, it reduces germ numbers in the wounds. Honey can be left on the wound for more than one day, as well as hydrogel, that is also used for contaminated wounds.
These new wound dressings are just used in a couple of Burn Units for the treatment of second-degree burns or split-skin grafted burns. However, the treatment of large burn wounds with older dressing regimes (e.g. PVP-Iod) cause intensive pain in every dressing change.
Only a few studies pointing at new dressings in burn wounds can be found in the literature. None of them reveals a high quality randomized trial.
The objective of this clinical investigation is a direct comparison of established and newer wound dressings with respect to epithelialization time, pain and the number of pathogenic microbe species. Besides, handling and cost are analyzed.
This is a prospective, randomised, factorial, open clinical study. Endpoint assessment, primarily the time to epithelialization, for direct comparison of the dressings is performed in a blinded way. The aim of this study is to identify the advantages of each dressing.
Every wound dressing will be used in every patient. The order from proximal to distal is varied so that every dressing is at every position in a balanced number of cases and has the same neighbor dressing in a balanced number of cases (Williams-Design). The order is assigned by randomisation. All comparisons of two wound dressing can be made using the same number of paired observations.
Assessors of epithelialization time and germ burden are blinded to the wound dressing used.
- Being tested
- Silver Nylon dressing, Manuka-Honey, Povidone-Iod (PVP-Iod), Hydrogel
- Keywords
- split-skin, burn wound, wound dressing, comparison, silver, honey, PVP-Iod, hydrogel
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver Nylon dressingDevice
Non-staining Silver Nylon dressing with a permanently plated metallic surface on split-skin grafted third-degree burn wound
Manuka-HoneyDevice
Manuka-Honey dressing on split-skin grafted third-degree burn wound
Povidone-Iod (PVP-Iod)Device
Povidone-Iod (PVP-Iod) dressing on split-skin grafted third-degree burn wound
HydrogelDevice
Hydrogel dressing on split-skin grafted third-degree burn wound
| Study group | Role | What they receive |
|---|---|---|
| Device: Silver Nylon dressing | Active comparator | 1/4 of a split-skin grafted third-degree burn wound in a Group (n=20): Consent-capable male and female patients ≥18 years of age who have a split-skin grafted third-degree burn on ≥3% and ≤30% of the surface of the body. Receives: Device: Silver Nylon dressing |
| Device: Manuka-Honey | Active comparator | 1/4 of a split-skin grafted third-degree burn wound in a Group (n=20): Consent-capable male and female patients ≥18 years of age who have a split-skin grafted third-degree burn on ≥3% and ≤30% of the surface of the body. Receives: Device: Manuka-Honey |
| Device: Povidone-Iod (PVP-Iod) | Active comparator | 1/4 of a split-skin grafted third-degree burn wound in a Group (n=20): Consent-capable male and female patients ≥18 years of age who have a split-skin grafted third-degree burn on ≥3% and ≤30% of the surface of the body. Receives: Device: Povidone-Iod (PVP-Iod) |
| Device: Hydrogel | Active comparator | 1/4 of a split-skin grafted third-degree burn wound in a Group (n=20): Consent-capable male and female patients ≥18 years of age who have a split-skin grafted third-degree burn on ≥3% and ≤30% of the surface of the body. Receives: Device: Hydrogel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epithelialization
Percent of epithelialized area
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
Pain (on a visual analogue scale 0-10)
Assessed by VAS (visual analogue scale). 0 means no pain, 10 means maximum pain.
Measured: through study completion, an average of 1 year
Microbiologic Smear
Assessed by gram staining and count
Measured: through study completion, an average of 1 year
Subjective Handling
Assessed by rating scale (0-5)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study startJul 2015
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Split-skin Grafted Third-degree Burn WoundStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 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 Hospital Schleswig-Holstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03674151
- Sponsor's protocol ID
- 15-145-2
- Status last verified
- Feb 2023
- First submitted
- 28 Jan 2017
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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
- Randomized-controlled Trial of Wound Healing, Pain, Microbiology, Handling and Thrift of Different Wound Dressings in Patients With Split-skin Grafted Third Degree Burns
- ClinicalTrials.gov ID
- NCT03674151
- Acronym / sponsor ID
- 15-145-2
- Keywords
- split-skin, burn wound, wound dressing, comparison, silver, honey, PVP-Iod, hydrogel
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Collaborators
- University of Luebeck
- Study start
- Jul 2015
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 17 Sep 2018 (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.
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 newer wound dressings, only a few studies comparing different wound dressings can be found. Therefore, the aim of this study is to evaluate time to reepithelialization, pain, microbiology, handling and costs of different wound dressings in patients with split-skin grafted third-degree burn wounds.
Detailed description
In the treatment of burn wounds polyhexanide and betaisodona (PVP-Iod) are regularly used today. They act as antiseptics, but both have drawbacks. Polyhexanide evaporates fast and therefore cools patients when applied to a large wound area. Moreover, it is known to reveal a gap for pseudomonas. On the other hand, the half-life of Betaisodona (PVP-Iod) ranges between several minutes and 12 hours. Further, its application causes intense pain, and it is cytotoxic. Other wound dressings involving silver are frequently used, too. However, they color the wounds, which might therefore not be properly assessed. Silver is also thought to be cytotoxic.
New innovations are available today. In wound dressings with bound Silver ions wounds are not colored. Hydrolytic membranes keep the level of acidity low (acidic) and have therefore antiseptic effects that last until epithelialization of a second-degree burn wounds is completed. Medical honey is used in the treatment of chronic wounds and especially in pediatric surgery and oncology. Manuka honey from New Zealand is sterilized before application and is known to be less painful for the patient. Due to its acidic effect, it reduces germ numbers in the wounds. Honey can be left on the wound for more than one day, as well as hydrogel, that is also used for contaminated wounds.
These new wound dressings are just used in a couple of Burn Units for the treatment of second-degree burns or split-skin grafted burns. However, the treatment of large burn wounds with older dressing regimes (e.g. PVP-Iod) cause intensive pain in every dressing change.
Only a few studies pointing at new dressings in burn wounds can be found in the literature. None of them reveals a high quality randomized trial.
The objective of this clinical investigation is a direct comparison of established and newer wound dressings with respect to epithelialization time, pain and the number of pathogenic microbe species. Besides, handling and cost are analyzed.
This is a prospective, randomised, factorial, open clinical study. Endpoint assessment, primarily the time to epithelialization, for direct comparison of the dressings is performed in a blinded way. The aim of this study is to identify the advantages of each dressing.
Every wound dressing will be used in every patient. The order from proximal to distal is varied so that every dressing is at every position in a balanced number of cases and has the same neighbor dressing in a balanced number of cases (Williams-Design). The order is assigned by randomisation. All comparisons of two wound dressing can be made using the same number of paired observations.
Assessors of epithelialization time and germ burden are blinded to the wound dressing used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Device: Silver Nylon dressing | Active comparator | Device: Silver Nylon dressing1/4 of a split-skin grafted third-degree burn wound in a Group (n=20): Consent-capable male and female patients ≥18 years of age who have a split-skin grafted third-degree burn on ≥3% and ≤30% of the surface of the body. |
| Device: Manuka-Honey | Active comparator | Device: Manuka-Honey1/4 of a split-skin grafted third-degree burn wound in a Group (n=20): Consent-capable male and female patients ≥18 years of age who have a split-skin grafted third-degree burn on ≥3% and ≤30% of the surface of the body. |
| Device: Povidone-Iod (PVP-Iod) | Active comparator | Device: Povidone-Iod (PVP-Iod)1/4 of a split-skin grafted third-degree burn wound in a Group (n=20): Consent-capable male and female patients ≥18 years of age who have a split-skin grafted third-degree burn on ≥3% and ≤30% of the surface of the body. |
| Device: Hydrogel | Active comparator | Device: Hydrogel1/4 of a split-skin grafted third-degree burn wound in a Group (n=20): Consent-capable male and female patients ≥18 years of age who have a split-skin grafted third-degree burn on ≥3% and ≤30% of the surface of the body. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Consent-capable male and female patients
- ≥18 years of age
- ≥3% and ≤30% total body surface area (TBSA) split-skin grafted third-degree burn
- appropriate form of wound (not: too small) and localization (not: face, inplane surface)
- ability to asses pain
Key exclusion criteria (6 listed)
- Immunosuppressive Therapy
- Clinical wound infection
- Allergy against porcine material, bee poison or honey, etherial oil, propyleneglycol, silver, nylon
- 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 |
|---|---|---|
| Silver Nylon dressingNon-staining Silver Nylon dressing with a permanently plated metallic surface on split-skin grafted third-degree burn wound | Device | Device: Silver Nylon dressing |
| Manuka-HoneyManuka-Honey dressing on split-skin grafted third-degree burn wound | Device | Device: Manuka-Honey |
| Povidone-Iod (PVP-Iod)Povidone-Iod (PVP-Iod) dressing on split-skin grafted third-degree burn wound | Device | Device: Povidone-Iod (PVP-Iod) |
| HydrogelHydrogel dressing on split-skin grafted third-degree burn wound | Device | Device: Hydrogel |
Primary outcome
Epithelialization
Time frame: through study completion, an average of 1 year
Percent of epithelialized area
3 secondary outcomes
Pain (on a visual analogue scale 0-10)
Time frame: through study completion, an average of 1 year
Microbiologic Smear
Time frame: through study completion, an average of 1 year
Subjective Handling
Time frame: through study completion, an average of 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
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 Hospital Schleswig-Holstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silver Nylon dressing, Manuka-Honey and Povidone-Iod (PVP-Iod) in people with Split-skin Grafted Third-degree Burn Wound, run by University Hospital Schleswig-Holstein at 1 site 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 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 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 1 site 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 (00494515003580, 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: through study completion, an average of 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.