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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2015

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Partial and full thickness burns with split thickness grafts

Clinical Trial Outcome Measures

Primary 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 Measures

  • Pain
    • Time Frame: 29 days
  • Pruritis
    • Time Frame: 29 days
  • Erythema
    • Time Frame: 29 days

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • B. Braun Ltd. Centre of Excellence Infection Control
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Adrien Daigeler, Prof., Principal Investigator, Berufsgenossenschaftliches Unfallklinikum Bergmannsheil Bochum
    • Jurij Kiefer, Dr., Principal Investigator, Berufsgenossenschaftliche Unfallklinik Ludwigshafen
    • Adrian Dragu, PD Dr. med., Principal Investigator, Klinikum St. Georg Leipzig

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