Third Degree BurnsPhase 3NCT01911858
Askina Calgitrol Paste Burns
A Phase 3 study testing Askina Calgitrol Paste in people with Third Degree Burns, run by BBraun Medical SAS.
Trial summary
The purpose of the study is to demonstrate that Askina® Calgitrol® Paste is safe to use on III degree burns by quantifying the concentration of silver in the blood during treatment and thus to show that the amount of silver absorbed will be no greater than those reported in the literature. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Third Degree Burns
- What is being tested?
- Askina Calgitrol Paste
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Dec 2013
- Phase
- Phase 3
- 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
- Adults (≥>18 years age). No upper age limit
- III degree thermal burns from 2-30% TBSA as determined by the Rule of Nines
- Patients who underwent initial treatment within 24 hours after the injury at the latest
- Patients who underwent initial treatment directly at the Burn Centre of FNKV or the initial treatment was in accordance with the standard of care of the Centre
- All patients will have been hospitalised
- Patients who are capable of giving signing informed consent and have done so.
Who cannot join
- Patients with electrical or chemical burns
- Patients with already infected wounds
- Patients taking systemic antibiotics on admission
- Patients pregnant or lactating
- Patients who fall into "vulnerable population" group with respect to informed consent or who are not capable of giving informed consent
- Patients who used or were treated with silver products for other reasons than treatment of the acute burn in the last 3 months
Show all 10Show fewer
- Patients whose other burn wounds are being treated with silver products.
- Patients receiving renal dialysis
- Known allergy or sensitivity to any of the ingredients in Askina® Calgitrol® Paste.
- Simultaneous participation in another interventional clinical trial
About this study
Official title: Non-controlled Prospective Cohort Study of the Use of Askina® Calgitrol® Paste on III Degree Burns in Adults
The purpose of the study is to demonstrate that Askina® Calgitrol® Paste is safe to use on III degree burns by quantifying the concentration of silver in the blood during treatment and thus to show that the amount of silver absorbed will be no greater than those reported in the literature.
- Conditions
- Third Degree Burns
- Being tested
- Askina Calgitrol Paste
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Askina Calgitrol PasteDevice
| Study group | Role | What they receive |
|---|---|---|
| Askina Calgitrol Paste | Experimental | Not described Receives: Device: Askina Calgitrol Paste |
What is being measured
The primary outcome is the main question the study is designed to answer.
The quantification of the amount of silver found in plasma during the treatment
Measured: Change from Baseline in Blood at 3 days
The quantification of the amount of silver found in plasma during the treatment
Measured: Change from Baseline in Blood immediately after the removal of the last investigational dressing (the day before necrotomy, an expected average between 3-10 days after inclusion)
Secondary outcomes (5)
Wound bed and periwound skin conditions
Data will not be recorded at specific time points due to individual changing patterns. The investigator will make a subjective description of the wound bed covered by necrosis, slough/fibrin, granulation tissue and epithelialisation and by the condition of the peri-wound skin.
Measured: At each dressing change (an expected average of one day)
Clinical signs of infection
Data will not be recorded at specific time points due to individual changing patterns.
The presence and intensity of clinical signs of infection will be assessed at the start of the study and at each dressing change using clinical judgment and a scoring system modified from the one published by Trial and al.
Measured: At each dressing change (an expected average of one day)
Patient comfort
Data will not be recorded at specific time points due to individual changing patterns.
The investigator will complete a Likert scale score (1-4, Poor, Fair, Good, Excellent) for each ease of application and ease of removal of Askina Calgitrol Paste at each dressing change.
Measured: At each dressing change (an expected average of one day)
Number of dressing changes
Data will not be recorded at specific time points due to individual changing patterns.
Measured: At each dressing change (an expected average of one day)
Adverse Events or Adverse device related event
Measured: At each dressing change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Third Degree 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 3
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- BBraun Medical SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01911858
- Sponsor's protocol ID
- OPM-G-H-1204
- Status last verified
- Aug 2014
- First submitted
- 25 Jul 2013
- Last updated
- 22 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-controlled Prospective Cohort Study of the Use of Askina® Calgitrol® Paste on III Degree Burns in Adults
- ClinicalTrials.gov ID
- NCT01911858
- Acronym / sponsor ID
- OPM-G-H-1204
- Conditions
- Third Degree Burns
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- BBraun Medical SASIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Dec 2013 (estimated)
- First posted
- 30 Jul 2013 (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 the study is to demonstrate that Askina® Calgitrol® Paste is safe to use on III degree burns by quantifying the concentration of silver in the blood during treatment and thus to show that the amount of silver absorbed will be no greater than those reported in the literature.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Askina Calgitrol Paste | Experimental | Device: Askina Calgitrol Paste |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults (≥>18 years age). No upper age limit
- III degree thermal burns from 2-30% TBSA as determined by the Rule of Nines
- Patients who underwent initial treatment within 24 hours after the injury at the latest
- Patients who underwent initial treatment directly at the Burn Centre of FNKV or the initial treatment was in accordance with the standard of care of the Centre
- All patients will have been hospitalised
Key exclusion criteria (10 listed)
- Patients with electrical or chemical burns
- Patients with already infected wounds
- Patients taking systemic antibiotics on admission
- Patients pregnant or lactating
- Patients who fall into "vulnerable population" group with respect to informed consent or who are not capable of giving informed consent
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 |
|---|---|---|
| Askina Calgitrol Paste | Device | Askina Calgitrol Paste |
Primary outcome
The quantification of the amount of silver found in plasma during the treatment
Time frame: Change from Baseline in Blood at 3 days
The quantification of the amount of silver found in plasma during the treatment
Time frame: Change from Baseline in Blood immediately after the removal of the last investigational dressing (the day before necrotomy, an expected average between 3-10 days after inclusion)
5 secondary outcomes
Wound bed and periwound skin conditions
Time frame: At each dressing change (an expected average of one day)
Clinical signs of infection
Time frame: At each dressing change (an expected average of one day)
Patient comfort
Time frame: At each dressing change (an expected average of one day)
Number of dressing changes
Time frame: At each dressing change (an expected average of one day)
Adverse Events or Adverse device related event
Time frame: At each dressing change
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Askina Calgitrol Paste in people with Third Degree Burns, run by BBraun Medical SAS.
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 10 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: withdrawn, as of the sponsor's last update on 22 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
The quantification of the amount of silver found in plasma during the treatment (time frame: Change from Baseline in Blood at 3 days). The study lists 2 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 22 Aug 2014; AzTrials last refreshed its copy on 26 Oct 2026.