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

July 31, 2018 updated by: B. Braun Ltd. Centre of Excellence Infection Control
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bochum, Germany, 44789
        • Berufsgenossenschaftliches Unfallklinikum Bergmannsheil
      • Leipzig, Germany, 44129
        • Klinikum St. Georg
    • Baden-Württemberg
      • Ludwigshafen, Baden-Württemberg, Germany, 67071
        • Berufsgenossenschaftliche Unfallklinik Ludwigshafen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Partial and full thickness burns with split thickness grafts
Device: Prontosan Wound Gel X
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.
Other Names:
  • polihexanide and betaine containing hydrogel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Graft neo-epithelisation
Time Frame: 29 days
29 days
Time to complete epithelization
Time Frame: 29 days
29 days
Wound infection
Time Frame: 29 days
29 days
Need for re-operation of target wound site
Time Frame: 29 days
29 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain
Time Frame: 29 days
29 days
Pruritis
Time Frame: 29 days
29 days
Erythema
Time Frame: 29 days
29 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

B. Braun Ltd. Centre of Excellence Infection Control

Investigators

  • Principal Investigator: Adrien Daigeler, Prof., Berufsgenossenschaftliches Unfallklinikum Bergmannsheil Bochum
  • Principal Investigator: Jurij Kiefer, Dr., Berufsgenossenschaftliche Unfallklinik Ludwigshafen
  • Principal Investigator: Adrian Dragu, PD Dr. med., Klinikum St. Georg Leipzig

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

February 10, 2012

First Submitted That Met QC Criteria

February 14, 2012

First Posted (Estimate)

February 17, 2012

Study Record Updates

Last Update Posted (Actual)

August 2, 2018

Last Update Submitted That Met QC Criteria

July 31, 2018

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPM-O-H-1102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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