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Manuka Honey in Second- and Grafted Third-degree Burns

Primary Purpose

Second-degree Burn, Third-Degree Burn

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
wound dressing
Sponsored by
University Hospital Schleswig-Holstein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Second-degree Burn

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Schleswig-Holstein
  • University of Schleswig-HolsteinRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Burn with or without split-skin graft

Arm Description

Second degree burns and third degree burns with split-skin graft that need wound dressings

Outcomes

Primary Outcome Measures

Epithelialization
Rate of Epithelialization in percent

Secondary Outcome Measures

Pain
Visual analog scale (VAS)
Microbiology
Microbiological smear is assessed by gram+, gram- or no bacterium
Handling
Scale (0-4)

Full Information

First Posted
January 28, 2017
Last Updated
February 22, 2023
Sponsor
University Hospital Schleswig-Holstein
Collaborators
University of Luebeck
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1. Study Identification

Unique Protocol Identification Number
NCT03048188
Brief Title
Manuka Honey in Second- and Grafted Third-degree Burns
Official Title
Clinical Application Observation of Manuka Honey in Second- and Grafted Third-degree Burns
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2015 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Schleswig-Holstein
Collaborators
University of Luebeck

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Second-degree Burn, Third-Degree Burn

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Burn with or without split-skin graft
Arm Type
Experimental
Arm Description
Second degree burns and third degree burns with split-skin graft that need wound dressings
Intervention Type
Other
Intervention Name(s)
wound dressing
Intervention Description
Manuka honey wound dressing
Primary Outcome Measure Information:
Title
Epithelialization
Description
Rate of Epithelialization in percent
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
Pain
Description
Visual analog scale (VAS)
Time Frame
Up to 1 year
Title
Microbiology
Description
Microbiological smear is assessed by gram+, gram- or no bacterium
Time Frame
Up to 1 year
Title
Handling
Description
Scale (0-4)
Time Frame
Up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tobias Kisch, MD
Phone
00494515000
Email
tobias.kisch@uni-luebeck.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tobias Kisch, MD
Organizational Affiliation
University of Lübeck, University Hospital Schleswig-Holstein
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Schleswig-Holstein
City
Lübeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany
Individual Site Status
Completed
Facility Name
University of Schleswig-Holstein
City
Lübeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tobias Kisch, MD
Phone
00494515002063
Email
tobias.kisch@uni-luebeck.de

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Manuka Honey in Second- and Grafted Third-degree Burns

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