Clinical trial NCT01534858: A Prospective, Descriptive Cohort Study With Prontosan® Wound Gel X in Partial and Full Thickness Burns Requiring Split Thickness Skin Grafts
Official title: A Prospective, Descriptive Cohort Study With Prontosan® Wound Gel X in Partial and Full Thickness Burns Requiring Split Thickness Skin Grafts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns
Keywords: polyhexanide, polihexanide, PHMB, Prontosan, burns, wounds
Lead sponsor: B. Braun Ltd. Centre of Excellence Infection Control
Sponsor class: INDUSTRY
First posted: 2012-02-17
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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).

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

Primary outcomes:
measure: Graft neo-epithelisation
timeFrame: 29 days
measure: Time to complete epithelization
timeFrame: 29 days
measure: Wound infection
timeFrame: 29 days
measure: Need for re-operation of target wound site
timeFrame: 29 days
Secondary outcomes:
measure: Pain
timeFrame: 29 days
measure: Pruritis
timeFrame: 29 days
measure: Erythema
timeFrame: 29 days
Other outcomes:
Locations:
city: Ludwigshafen
country: Germany
facility: Berufsgenossenschaftliche Unfallklinik Ludwigshafen
state: Baden-Württemberg
city: Bochum
country: Germany
facility: Berufsgenossenschaftliches Unfallklinikum Bergmannsheil
city: Leipzig
country: Germany
facility: Klinikum St. Georg
Study officials:
affiliation: Berufsgenossenschaftliches Unfallklinikum Bergmannsheil Bochum
name: Adrien Daigeler, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Berufsgenossenschaftliche Unfallklinik Ludwigshafen
name: Jurij Kiefer, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinikum St. Georg Leipzig
name: Adrian Dragu, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: