A Prospective, Descriptive Cohort Study With Prontosan® Wound Gel X in Partial and Full Thickness Burns Requiring Split Thickness Skin Grafts
This study is currently recruiting participants.
Verified March 2012 by B. Braun Ltd. Centre of Excellence Infection Control
Sponsor:
B. Braun Ltd. Centre of Excellence Infection Control
Information provided by (Responsible Party):
B. Braun Ltd. Centre of Excellence Infection Control
ClinicalTrials.gov Identifier:
NCT01534858
First received: February 10, 2012
Last updated: March 7, 2012
Last verified: March 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Burns |
Device: Prontosan Wound Gel X |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | A Prospective, Descriptive Cohort Study With Prontosan® Wound Gel X in Partial and Full Thickness Burns Requiring Split Thickness Skin Grafts |
Resource links provided by NLM:
Further study details as provided by B. Braun Ltd. Centre of Excellence Infection Control:
Primary Outcome Measures:
- Graft neo-epithelisation [ Time Frame: 29 days ] [ Designated as safety issue: No ]
- Time to complete epithelization [ Time Frame: 29 days ] [ Designated as safety issue: No ]
- Wound infection [ Time Frame: 29 days ] [ Designated as safety issue: No ]
- Need for re-operation of target wound site [ Time Frame: 29 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Pain [ Time Frame: 29 days ] [ Designated as safety issue: No ]
- Pruritis [ Time Frame: 29 days ] [ Designated as safety issue: Yes ]
- Erythema [ Time Frame: 29 days ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 50 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Partial and full thickness burns with split thickness grafts |
Device: Prontosan 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.
Other Name: polihexanide and betaine containing hydrogel
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01534858
Contacts
| Contact: Adrien Daigeler, MD | +49 621 6810 2940/2944 | adaigeler@bgu-ludwigshafen.de |
Locations
| Germany | |
| Berufsgenossenschaftliche Unfallklinik Ludwigshafen | Recruiting |
| Ludwigshafen, Baden-Württemberg, Germany, 67071 | |
| Principal Investigator: Adrien Daigeler, MD | |
Sponsors and Collaborators
B. Braun Ltd. Centre of Excellence Infection Control
Investigators
| Principal Investigator: | Adrien Daigeler, MD | Berufsgenossenschaftliche Unfallklinik Ludwigshafen |
More Information
No publications provided
| Responsible Party: | B. Braun Ltd. Centre of Excellence Infection Control |
| ClinicalTrials.gov Identifier: | NCT01534858 History of Changes |
| Other Study ID Numbers: | OPM-O-H-1102 |
| Study First Received: | February 10, 2012 |
| Last Updated: | March 7, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by B. Braun Ltd. Centre of Excellence Infection Control:
|
polyhexanide, polihexanide, PHMB, Prontosan, burns, wounds |
Additional relevant MeSH terms:
|
Burns Wounds and Injuries |
ClinicalTrials.gov processed this record on June 17, 2013