Manuka Honey in Second- and Grafted Third-degree Burns | NCT03048188

Studies
Manuka Honey in Second- and Grafted Third-degree Burns

NCT03048188

Sponsor

University Hospital Schleswig-Holstein

Status

Unknown status

Last Update Posted

Feb 24, 2023Actual

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Second-degree Burn
Third-Degree Burn

Interventions

wound dressing

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 15, 2015Actual

Primary Completion Date

Dec 2023Estimated

Completion Date

Dec 2023Estimated

First Submitted Date

Jan 28, 2017

First Submission Date that Met QC Criteria

Feb 7, 2017

First Posted Date

Feb 9, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 22, 2023

Last Update Posted Date

Feb 24, 2023Actual

Name	Class
University of Luebeck	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
wound dressing	Other	Manuka honey wound dressing	Burn with or without split-skin graft

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tobias Kisch, MD	Contact	00494515000		tobias.kisch@uni-luebeck.de

Overall Officials

Name	Affiliation	Role
Tobias Kisch, MD	University of Lübeck, University Hospital Schleswig-Holstein	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Schleswig-Holstein	Completed	Lübeck	Schleswig-Holstein	23538	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided