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Trial record 1 of 1 for:    NCT03048188
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Manuka Honey in Second- and Grafted Third-degree Burns

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ClinicalTrials.gov Identifier: NCT03048188
Recruitment Status : Unknown
Verified December 2019 by Tobias Kisch, University Hospital Schleswig-Holstein.
Recruitment status was:  Recruiting
First Posted : February 9, 2017
Last Update Posted : December 3, 2019
Sponsor:
Collaborator:
University of Luebeck
Information provided by (Responsible Party):
Tobias Kisch, University Hospital Schleswig-Holstein

Brief 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 split-skin grafted burn wounds.

Condition or disease Intervention/treatment Phase
Second-degree Burn Third-Degree Burn Other: wound dressing Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Application Observation of Manuka Honey in Second- and Grafted Third-degree Burns
Actual Study Start Date : July 15, 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Burn with or without split-skin graft
Second degree burns and third degree burns with split-skin graft that need wound dressings
Other: wound dressing
Manuka honey wound dressing




Primary Outcome Measures :
  1. Epithelialization [ Time Frame: Up to 1 year ]
    Rate of Epithelialization in percent


Secondary Outcome Measures :
  1. Pain [ Time Frame: Up to 1 year ]
    Visual analog scale (VAS)

  2. Microbiology [ Time Frame: Up to 1 year ]
    Microbiological smear is assessed by gram+, gram- or no bacterium

  3. Handling [ Time Frame: Up to 1 year ]
    Scale (0-4)



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 (or guardian)
  • ≥18 years of age
  • ability to asses pain

Exclusion Criteria:

  • 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

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): NCT03048188


Contacts
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Contact: Tobias Kisch, MD 00494515000 tobias.kisch@uksh.de

Locations
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Germany
University Hospital Schleswig-Holstein Completed
Lübeck, Schleswig-Holstein, Germany, 23538
University of Schleswig-Holstein Recruiting
Lübeck, Schleswig-Holstein, Germany, 23538
Contact: Tobias Kisch, MD    00494515002063    tobias.kisch@uksh.de   
Sponsors and Collaborators
University Hospital Schleswig-Holstein
University of Luebeck
Investigators
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Principal Investigator: Tobias Kisch, MD University of Lübeck, University Hospital Schleswig-Holstein
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Responsible Party: Tobias Kisch, MD, University Hospital Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT03048188    
Other Study ID Numbers: 14-265
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Additional relevant MeSH terms:
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Burns
Wounds and Injuries