NCT03048188

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 9, 2017

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

February 24, 2023

Status Verified

February 1, 2023

Enrollment Period

8.4 years

First QC Date

January 28, 2017

Last Update Submit

February 22, 2023

Conditions

Second-degree BurnThird-Degree Burn

Outcome Measures

Primary Outcomes (1)

  • Epithelialization

    Rate of Epithelialization in percent

    Up to 1 year

Secondary Outcomes (3)

  • Pain

    Up to 1 year

  • Microbiology

    Up to 1 year

  • Handling

    Up to 1 year

Study Arms (1)

Burn with or without split-skin graft

EXPERIMENTAL

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

Other: wound dressing

Interventions

wound dressingOTHER

Manuka honey wound dressing

Burn with or without split-skin graft

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consent-capable male and female patients (or guardian)
  • ≥18 years of age
  • ability to asses pain

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Schleswig-Holstein

Lübeck, Schleswig-Holstein, 23538, Germany

COMPLETED

University of Schleswig-Holstein

Lübeck, Schleswig-Holstein, 23538, Germany

RECRUITING

MeSH Terms

Interventions

Bandages

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Tobias Kisch, MD

    University of Lübeck, University Hospital Schleswig-Holstein

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tobias Kisch, MD

CONTACT

00494515000tobias.kisch@uni-luebeck.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 28, 2017

First Posted

February 9, 2017

Study Start

July 15, 2015

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

February 24, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

DE(2)