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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2015-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Burns

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Partial and full thickness burns with split thickness grafts

Group Type EXPERIMENTAL

Prontosan Wound Gel X

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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polihexanide and betaine containing hydrogel

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No