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

Not Applicable

Completed

• Conditions: Burns
• Interventions: Device: Prontosan Wound Gel X

• Registration Number: NCT01534858
• Lead Sponsor: B. Braun Ltd. Centre of Excellence Infection Control

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-10
• Study First Submitted QC: 2012-02-14
• Study First Posted: 2012-02-17
• Study Start: 2012-03
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-09
• Last Update Submitted: 2018-07-31
• Last Update Posted: 2018-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Partial and full thickness burns with split thickness grafts	Prontosan Wound Gel X	-

Primary Outcome Measures

Name	Time	Method
Graft neo-epithelisation	29 days
Wound infection	29 days
Need for re-operation of target wound site	29 days
Time to complete epithelization	29 days

Secondary Outcome Measures

Name	Time	Method
Pruritis	29 days
Erythema	29 days
Pain	29 days

Trial Locations

Locations (3)

Berufsgenossenschaftliches Unfallklinikum Bergmannsheil; 🇩🇪 Bochum, Germany

Klinikum St. Georg; 🇩🇪 Leipzig, Germany

Berufsgenossenschaftliche Unfallklinik Ludwigshafen; 🇩🇪 Ludwigshafen, Baden-Württemberg, Germany