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Trial of Different Wound Dressings in Split-skin Grafted Third Degree Burns

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ClinicalTrials.gov Identifier: NCT03674151
Recruitment Status : Recruiting
First Posted : September 17, 2018
Last Update Posted : December 3, 2019
Sponsor:
Collaborator:
University of Luebeck
Information provided by (Responsible Party):
Tobias Kisch, University of Schleswig-Holstein

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Split-skin Grafted Third-degree Burn Wound Device: Silver Nylon dressing Device: Manuka-Honey Device: Povidone-Iod (PVP-Iod) Device: Hydrogel Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : July 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Povidone

Arm Intervention/treatment
Active Comparator: Device: Silver Nylon dressing
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: Silver Nylon dressing
Non-staining Silver Nylon dressing with a permanently plated metallic surface on split-skin grafted third-degree burn wound

Active Comparator: Device: Manuka-Honey
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: Manuka-Honey
Manuka-Honey dressing on split-skin grafted third-degree burn wound

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: Povidone-Iod (PVP-Iod)
Povidone-Iod (PVP-Iod) dressing on split-skin grafted third-degree burn wound

Active Comparator: Device: Hydrogel
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
Hydrogel dressing on split-skin grafted third-degree burn wound




Primary Outcome Measures :
  1. Epithelialization [ Time Frame: through study completion, an average of 1 year ]
    Percent of epithelialized area


Secondary Outcome Measures :
  1. Pain (on a visual analogue scale 0-10) [ Time Frame: through study completion, an average of 1 year ]
    Assessed by VAS (visual analogue scale). 0 means no pain, 10 means maximum pain.

  2. Microbiologic Smear [ Time Frame: through study completion, an average of 1 year ]
    Assessed by gram staining and count

  3. Subjective Handling [ Time Frame: through study completion, an average of 1 year ]
    Assessed by rating scale (0-5)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03674151


Contacts
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Contact: Tobias Kisch, MD 00494515003580 tobias.kisch@uksh.de
Contact: Reinhard Vonthein, PhD 00494515002788 vonthein@zks-hl.de

Locations
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Germany
University of Schleswig-Holstein Recruiting
Lübeck, Schleswig-Holstein, Germany, 23538
Contact: Tobias Kisch, MD    00494515003580    tobias.kisch@uksh.de   
Sponsors and Collaborators
University of Schleswig-Holstein
University of Luebeck
Investigators
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Principal Investigator: Tobias Kisch, MD University of Schleswig-Holstein
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Responsible Party: Tobias Kisch, Principal Investigator, University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT03674151    
Other Study ID Numbers: 15-145-2
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Tobias Kisch, University of Schleswig-Holstein:
split-skin
burn wound
wound dressing
comparison
silver
honey
PVP-Iod
hydrogel
Additional relevant MeSH terms:
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Burns
Wounds and Injuries
Povidone
Plasma Substitutes
Blood Substitutes