Manuka Honey in Second- and Grafted Third-degree Burns

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.

Study Overview

• Status: Recruiting
• Conditions: Second-degree Burn; Third-Degree Burn
• Intervention / Treatment: Other: wound dressing

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 Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tobias Kisch, MD; Phone Number: 00494515000; Email: tobias.kisch@uni-luebeck.de

Study Locations

• Germany
  • Schleswig-Holstein
    • Lübeck, Schleswig-Holstein, Germany, 23538
      • Recruiting
      • University of Schleswig-Holstein
      • Contact: Tobias Kisch, MD; Phone Number: 00494515002063; Email: tobias.kisch@uni-luebeck.de
    • Lübeck, Schleswig-Holstein, Germany, 23538
      • Completed
      • University Hospital Schleswig-Holstein

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epithelialization	Rate of Epithelialization in percent	Up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	Visual analog scale (VAS)	Up to 1 year
Microbiology	Microbiological smear is assessed by gram+, gram- or no bacterium	Up to 1 year
Handling	Scale (0-4)	Up to 1 year

Collaborators and Investigators

• Sponsor: University Hospital Schleswig-Holstein
• Collaborators: University of Luebeck

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2015
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: January 28, 2017
• First Submitted That Met QC Criteria: February 7, 2017
• First Posted (Estimate): February 9, 2017

Study Record Updates

• Last Update Posted (Actual): February 24, 2023
• Last Update Submitted That Met QC Criteria: February 22, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: 14-265

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No