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

Sponsor

B. Braun Ltd. Centre of Excellence Infection Control (Industry)

Overall Status

Completed

CT.gov ID

NCT01534858

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Burns	Device: Prontosan Wound Gel X	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

51 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Mar 1, 2012

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Partial and full thickness burns with split thickness grafts	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. Other Names: polihexanide and betaine containing hydrogel

Arm

Intervention/Treatment

Experimental: Partial and full thickness burns with split thickness grafts

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.

Other Names:

polihexanide and betaine containing hydrogel

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Pain [29 days]
Pruritis [29 days]
Erythema [29 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Berufsgenossenschaftliche Unfallklinik Ludwigshafen	Ludwigshafen	Baden-Württemberg	Germany	67071
2	Berufsgenossenschaftliches Unfallklinikum Bergmannsheil	Bochum		Germany	44789
3	Klinikum St. Georg	Leipzig		Germany	44129

Sponsors and Collaborators

B. Braun Ltd. Centre of Excellence Infection Control

Investigators

Principal Investigator: Adrien Daigeler, Prof., Berufsgenossenschaftliches Unfallklinikum Bergmannsheil Bochum
Principal Investigator: Jurij Kiefer, Dr., Berufsgenossenschaftliche Unfallklinik Ludwigshafen
Principal Investigator: Adrian Dragu, PD Dr. med., Klinikum St. Georg Leipzig