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Completed

NCT Number: NCT01534858

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Berufsgenossenschaftliche Unfallklinik Ludwigshafen, Ludwigshafen, Baden-Wurttemberg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prontosan Wound Gel X

Device

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

Primary outcomes

  1. Graft neo-epithelisation

    Time frame: 29 days

  2. Time to complete epithelization

    Time frame: 29 days

  3. Wound infection

    Time frame: 29 days

  4. Need for re-operation of target wound site

    Time frame: 29 days

Secondary outcomes

  1. Pain

    Time frame: 29 days

  2. Pruritis

    Time frame: 29 days

  3. Erythema

    Time frame: 29 days

Sponsors and collaborators

Lead sponsor

B. Braun Ltd. Centre of Excellence Infection Control

Industry

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Feb 17, 2012
Registry last updated
Aug 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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