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

Burns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01534858
• Other study ID #: OPM-O-H-1102
• Status: Completed
• Phase: N/A
• Start date: March 2012
• Est. completion date: June 2015

Study information

• Verified date: September 2015
• Source: B. Braun Ltd. Centre of Excellence Infection Control
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burns

Intervention

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.

Locations

Country	Name	City	State
Germany	Berufsgenossenschaftliches Unfallklinikum Bergmannsheil	Bochum
Germany	Klinikum St. Georg	Leipzig
Germany	Berufsgenossenschaftliche Unfallklinik Ludwigshafen	Ludwigshafen	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
B. Braun Ltd. Centre of Excellence Infection Control

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Graft neo-epithelisation		29 days
Primary	Time to complete epithelization		29 days
Primary	Wound infection		29 days
Primary	Need for re-operation of target wound site		29 days
Secondary	Pain		29 days
Secondary	Pruritis		29 days
Secondary	Erythema		29 days

External Links

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