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

Study 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.

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

Conditions
-----------------
Burns

Intervention / Treatment
-----------------
* Device: Prontosan Wound Gel X


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Partial and full thickness burns with split thickness grafts<br> | Device: Prontosan Wound Gel X<br>* 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.<br>* Other names: polihexanide and betaine containing hydrogel;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain |  | 29 days | 
| Pruritis |  | 29 days | 
| Erythema |  | 29 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
polyhexanide, polihexanide, PHMB, Prontosan, burns, wounds