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

B. Braun Ltd. Centre of Excellence Infection Control3 sites in 1 country51 target enrollmentMarch 2012

ConditionsBurns

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Burns
Sponsor: B. Braun Ltd. Centre of Excellence Infection Control
Enrollment: 51
Locations: 3
Primary Endpoint: Graft neo-epithelisation
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2012

End Date

June 2015

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

B. Braun Ltd. Centre of Excellence Infection Control

Responsible Party

Sponsor

Eligibility Criteria

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).