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

B. Braun

Status: Completed

Conditions: Burns

Treatments: Device: Prontosan Wound Gel X

Study type: Interventional

Funder types: Industry

Identifiers

NCT01534858

OPM-O-H-1102

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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51 participants in 1 patient group

Partial and full thickness burns with split thickness grafts

Experimental group

Treatment:

Device: Prontosan Wound Gel X