BurnsNCT01534858
A Prospective, Descriptive Cohort Study With Prontosan® Wound Gel X in Partial and Full Thickness Burns Requiring Split Thickness Skin Grafts
A study testing Prontosan Wound Gel X in people with Burns, run by B. Braun Ltd. Centre of Excellence Infection Control at 3 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns
- What is being tested?
- Prontosan Wound Gel X
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 3 sitesGermany
- Study dates
- Mar 2012to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 13Show fewer
- 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 locations and contacts
3 sites in 1 country.
Germany3 sites
Berufsgenossenschaftliches Unfallklinikum Bergmannsheil
Bochum, 44789
Klinikum St. Georg
Leipzig, 44129
Berufsgenossenschaftliche Unfallklinik Ludwigshafen
Ludwigshafen, Baden-Wurttemberg, 67071
About this study
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.
- Conditions
- Burns
- Being tested
- Prontosan Wound Gel X
- Keywords
- polyhexanide, polihexanide, PHMB, Prontosan, burns, wounds
- Medical subject headings
- Burns, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prontosan Wound Gel XDevice
Also called polihexanide and betaine containing hydrogel
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 group | Role | What they receive |
|---|---|---|
| Partial and full thickness burns with split thickness grafts | Experimental | Not described Receives: Device: Prontosan Wound Gel X |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft neo-epithelisation
Measured: 29 days
Time to complete epithelization
Measured: 29 days
Wound infection
Measured: 29 days
Need for re-operation of target wound site
Measured: 29 days
Secondary outcomes (3)
Pain
Measured: 29 days
Pruritis
Measured: 29 days
Erythema
Measured: 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- B. Braun Ltd. Centre of Excellence Infection Control
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adrien Daigeler, Prof., Principal investigator, Berufsgenossenschaftliches Unfallklinikum Bergmannsheil BochumJurij Kiefer, Dr., Principal investigator, Berufsgenossenschaftliche Unfallklinik LudwigshafenAdrian Dragu, PD Dr. med., Principal investigator, Klinikum St. Georg Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01534858
- Sponsor's protocol ID
- OPM-O-H-1102
- Status last verified
- Sep 2015
- First submitted
- 10 Feb 2012
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Descriptive Cohort Study With Prontosan® Wound Gel X in Partial and Full Thickness Burns Requiring Split Thickness Skin Grafts
- ClinicalTrials.gov ID
- NCT01534858
- Acronym / sponsor ID
- OPM-O-H-1102
- Conditions
- Burns
- Keywords
- polyhexanide, polihexanide, PHMB, Prontosan, burns, wounds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- B. Braun Ltd. Centre of Excellence Infection ControlIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 17 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Partial and full thickness burns with split thickness grafts | Experimental | Device: Prontosan Wound Gel X |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prontosan Wound Gel XAlso: polihexanide and betaine containing hydrogelProntasan Wound Gel X will be applied topically as a thin layer to the entire grafted area immediately after transplant and with each dressing change. | Device | Partial and full thickness burns with split thickness grafts |
Primary outcome
Graft neo-epithelisation
Time frame: 29 days
Time to complete epithelization
Time frame: 29 days
Wound infection
Time frame: 29 days
Need for re-operation of target wound site
Time frame: 29 days
3 secondary outcomes
Pain
Time frame: 29 days
Pruritis
Time frame: 29 days
Erythema
Time frame: 29 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2018.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrien Daigeler, Prof. principal investigator
Berufsgenossenschaftliches Unfallklinikum Bergmannsheil Bochum
Jurij Kiefer, Dr. principal investigator
Berufsgenossenschaftliche Unfallklinik Ludwigshafen
Adrian Dragu, PD Dr. med. principal investigator
Klinikum St. Georg Leipzig
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prontosan Wound Gel X in people with Burns, run by B. Braun Ltd. Centre of Excellence Infection Control at 3 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft neo-epithelisation (time frame: 29 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2018.