Manuka Honey in Second- and Grafted Third-degree Burns

Second-degree Burn Clinical Trial

Official title:

Clinical Application Observation of Manuka Honey in Second- and Grafted Third-degree Burns

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03048188
• Other study ID #: 14-265
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2015
• Est. completion date: December 2023

Study information

• Verified date: February 2023
• Source: University Hospital Schleswig-Holstein
• Contact: Tobias Kisch, MD
• Phone: 00494515000
• Email: tobias.kisch[@]uni-luebeck.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burns
• Second-degree Burn
• Third-Degree Burn

Intervention

Other:
• wound dressing
Manuka honey wound dressing

Locations

Country	Name	City	State
Germany	University Hospital Schleswig-Holstein	Lübeck	Schleswig-Holstein
Germany	University of Schleswig-Holstein	Lübeck	Schleswig-Holstein

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Schleswig-Holstein	University of Luebeck

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epithelialization	Rate of Epithelialization in percent	Up to 1 year
Secondary	Pain	Visual analog scale (VAS)	Up to 1 year
Secondary	Microbiology	Microbiological smear is assessed by gram+, gram- or no bacterium	Up to 1 year
Secondary	Handling	Scale (0-4)	Up to 1 year