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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01534858

Enrollment

Registered

2012-02-17

Start date

2012-03-31

Completion date

2015-06-30

Last updated

2018-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burns

Keywords

polyhexanide, polihexanide, PHMB, Prontosan, burns, wounds

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.

Interventions

DEVICEProntosan Wound Gel X

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	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

Measure	Time frame
Pruritis	29 days
Erythema	29 days
Pain	29 days

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026