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

This study is currently recruiting participants.
Verified April 2014 by B. Braun Ltd. Centre of Excellence Infection Control
Sponsor:
Information provided by (Responsible Party):
B. Braun Ltd. Centre of Excellence Infection Control
ClinicalTrials.gov Identifier:
NCT01534858
First received: February 10, 2012
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Burns
Device: Prontosan Wound Gel X
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Prospective, Descriptive Cohort Study With Prontosan® Wound Gel X in Partial and Full Thickness Burns Requiring Split Thickness Skin Grafts

Resource links provided by NLM:


Further study details as provided by B. Braun Ltd. Centre of Excellence Infection Control:

Primary Outcome Measures:
  • Graft neo-epithelisation [ Time Frame: 29 days ] [ Designated as safety issue: No ]
  • Time to complete epithelization [ Time Frame: 29 days ] [ Designated as safety issue: No ]
  • Wound infection [ Time Frame: 29 days ] [ Designated as safety issue: No ]
  • Need for re-operation of target wound site [ Time Frame: 29 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain [ Time Frame: 29 days ] [ Designated as safety issue: No ]
  • Pruritis [ Time Frame: 29 days ] [ Designated as safety issue: Yes ]
  • Erythema [ Time Frame: 29 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: March 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: polihexanide and betaine containing hydrogel

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01534858

Contacts
Contact: Adrien Daigeler, MD +49 621 6810 2940/2944 adaigeler@bgu-ludwigshafen.de

Locations
Germany
Berufsgenossenschaftliche Unfallklinik Ludwigshafen Recruiting
Ludwigshafen, Baden-Württemberg, Germany, 67071
Principal Investigator: Jurij Kiefer, MD         
Berufsgenossenschaftliches Unfallklinikum Bergmannsheil Recruiting
Bochum, Germany, 44789
Principal Investigator: Adrien Daigeler, Prof         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: B. Braun Ltd. Centre of Excellence Infection Control
ClinicalTrials.gov Identifier: NCT01534858     History of Changes
Other Study ID Numbers: OPM-O-H-1102
Study First Received: February 10, 2012
Last Updated: April 2, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by B. Braun Ltd. Centre of Excellence Infection Control:
polyhexanide, polihexanide, PHMB, Prontosan, burns, wounds

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on April 16, 2014