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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03048188
Other study ID # 14-265
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
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Completed NCT03530150 - Pirfenidone and Its Role in Burn Wound Healing Phase 2