Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT01534858
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01534858
Study Brief:
Protocol Section:
NCT01534858