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A Prospective, Descriptive Cohort Study With Prontosan® Wound Gel X in Partial and Full Thickness Burns Requiring Split Thickness Skin Grafts

Primary Purpose

Burns

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Prontosan Wound Gel X
Sponsored by
B. Braun Ltd. Centre of Excellence Infection Control
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Burns focused on measuring polyhexanide, polihexanide, PHMB, Prontosan, burns, wounds

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Partial of full thickness burns requiring split thickness grafts
  • Target burn wound size 10cm2-1000cm2
  • Age ≥ 18 years
  • Ability to read, write and speak German.
  • Provision of voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent approved by the Institutional Ethics Committee (IEC) prior to all evaluations. Informed consent will be obtained from the patient or by a legal representative if the patient is not able/competent to consent. In this case, informed consent will be also obtained by the patient when he/she regains competence.
  • Women of child bearing potential must test negative on standard urine pregnancy test and must agree to practice appropriate contraceptive methods for the duration of the study (e. g. oral contraceptive, IUD, intra-muscular contraceptive, abstinence).

Exclusion Criteria:

  • Target wound has exposed hyaline cartilage
  • Connective tissue disorder
  • Previous skin graft failure at target wound site
  • Total burn surface area ≥ 70%
  • Infected target wound
  • Immunosuppression therapy
  • Chronic hemodialysis
  • Steroid use
  • Diabetes (Type I)
  • Allergy or sensitivity to any of the ingredients in Prontosan® Wound Gel X
  • Allergy or sensitivity to chlorhexidine
  • Pregnancy
  • Simultaneous participation in another clinical trial

Sites / Locations

  • Berufsgenossenschaftliche Unfallklinik Ludwigshafen
  • Berufsgenossenschaftliches Unfallklinikum Bergmannsheil
  • Klinikum St. Georg

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Partial and full thickness burns with split thickness grafts

Arm Description

Outcomes

Primary Outcome Measures

Graft neo-epithelisation
Time to complete epithelization
Wound infection
Need for re-operation of target wound site

Secondary Outcome Measures

Pain
Pruritis
Erythema

Full Information

First Posted
February 10, 2012
Last Updated
July 31, 2018
Sponsor
B. Braun Ltd. Centre of Excellence Infection Control
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1. Study Identification

Unique Protocol Identification Number
NCT01534858
Brief Title
A Prospective, Descriptive Cohort Study With Prontosan® Wound Gel X in Partial and Full Thickness Burns Requiring Split Thickness Skin Grafts
Official Title
A Prospective, Descriptive Cohort Study With Prontosan® Wound Gel X in Partial and Full Thickness Burns Requiring Split Thickness Skin Grafts
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
B. Braun Ltd. Centre of Excellence Infection Control

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the healing of split thickness skin grafts when treated with Prontosan® Wound Gel X in patients with partial and full thickness skin burns.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
Keywords
polyhexanide, polihexanide, PHMB, Prontosan, burns, wounds

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Partial and full thickness burns with split thickness grafts
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Prontosan Wound Gel X
Other Intervention Name(s)
polihexanide and betaine containing hydrogel
Intervention Description
Prontasan Wound Gel X will be applied topically as a thin layer to the entire grafted area immediately after transplant and with each dressing change.
Primary Outcome Measure Information:
Title
Graft neo-epithelisation
Time Frame
29 days
Title
Time to complete epithelization
Time Frame
29 days
Title
Wound infection
Time Frame
29 days
Title
Need for re-operation of target wound site
Time Frame
29 days
Secondary Outcome Measure Information:
Title
Pain
Time Frame
29 days
Title
Pruritis
Time Frame
29 days
Title
Erythema
Time Frame
29 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Partial of full thickness burns requiring split thickness grafts Target burn wound size 10cm2-1000cm2 Age ≥ 18 years Ability to read, write and speak German. Provision of voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent approved by the Institutional Ethics Committee (IEC) prior to all evaluations. Informed consent will be obtained from the patient or by a legal representative if the patient is not able/competent to consent. In this case, informed consent will be also obtained by the patient when he/she regains competence. Women of child bearing potential must test negative on standard urine pregnancy test and must agree to practice appropriate contraceptive methods for the duration of the study (e. g. oral contraceptive, IUD, intra-muscular contraceptive, abstinence). Exclusion Criteria: Target wound has exposed hyaline cartilage Connective tissue disorder Previous skin graft failure at target wound site Total burn surface area ≥ 70% Infected target wound Immunosuppression therapy Chronic hemodialysis Steroid use Diabetes (Type I) Allergy or sensitivity to any of the ingredients in Prontosan® Wound Gel X Allergy or sensitivity to chlorhexidine Pregnancy Simultaneous participation in another clinical trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrien Daigeler, Prof.
Organizational Affiliation
Berufsgenossenschaftliches Unfallklinikum Bergmannsheil Bochum
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jurij Kiefer, Dr.
Organizational Affiliation
Berufsgenossenschaftliche Unfallklinik Ludwigshafen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adrian Dragu, PD Dr. med.
Organizational Affiliation
Klinikum St. Georg Leipzig
Official's Role
Principal Investigator
Facility Information:
Facility Name
Berufsgenossenschaftliche Unfallklinik Ludwigshafen
City
Ludwigshafen
State/Province
Baden-Württemberg
ZIP/Postal Code
67071
Country
Germany
Facility Name
Berufsgenossenschaftliches Unfallklinikum Bergmannsheil
City
Bochum
ZIP/Postal Code
44789
Country
Germany
Facility Name
Klinikum St. Georg
City
Leipzig
ZIP/Postal Code
44129
Country
Germany

12. IPD Sharing Statement

Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/29668985
Description
Related Info

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A Prospective, Descriptive Cohort Study With Prontosan® Wound Gel X in Partial and Full Thickness Burns Requiring Split Thickness Skin Grafts

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