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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01534858
First Posted: February 17, 2012
Last Update Posted: September 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
B. Braun Ltd. Centre of Excellence Infection Control
  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
Burns Device: Prontosan Wound Gel X

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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 ]
  • Time to complete epithelization [ Time Frame: 29 days ]
  • Wound infection [ Time Frame: 29 days ]
  • Need for re-operation of target wound site [ Time Frame: 29 days ]

Secondary Outcome Measures:
  • Pain [ Time Frame: 29 days ]
  • Pruritis [ Time Frame: 29 days ]
  • Erythema [ Time Frame: 29 days ]

Enrollment: 51
Study Start Date: March 2012
Study Completion Date: June 2015
Primary Completion Date: June 2015 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01534858


Locations
Germany
Berufsgenossenschaftliche Unfallklinik Ludwigshafen
Ludwigshafen, Baden-Württemberg, Germany, 67071
Berufsgenossenschaftliches Unfallklinikum Bergmannsheil
Bochum, Germany, 44789
Klinikum St. Georg
Leipzig, Germany, 44129
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
Principal Investigator: Adrian Dragu, PD Dr. med. Klinikum St. Georg Leipzig
  More Information

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
First Submitted: February 10, 2012
First Posted: February 17, 2012
Last Update Posted: September 22, 2015
Last Verified: September 2015

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
Polihexanide
Disinfectants
Anti-Infective Agents