Burn Wounds - Partial Thickness (2nd Degree)NCT00343824
Bacterial Control in Partial Thickness Burns Using Silver-containing Wound Dressings
A study testing aquacel AG hydrofiber versus acticoat burn dressing in people with Burn Wounds - Partial Thickness (2nd Degree), run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
This study is to compare the treatment with two different silver-containing wound dressings: aquacel AG hydrofiber versus acticoat burn dressing. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Burn Wounds - Partial Thickness (2nd Degree)
- What is being tested?
- aquacel AG hydrofiber versus acticoat burn dressing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Nov 2006to 31 Jul 2010
- 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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Burn wounds with flux values, measured by Laser Doppler Imaging, corresponding with expected healing time between 7 and 21 days, flux values between 200 and 1000 (red-pink or pink-yellow-green colour)
- Wounds treated with a hydrocolloid paste prior to LDI
- Possibility to follow the complete treatment schedule until wound healing and participation on complete follow-up schedule
- Informed consent
- Partial thickness burns with TBSE < 40%
Who cannot join
- Mean flux values < 200 or > 1000
- TBSA > 40%
- Impossibility to debride necrotic skin prior to LDI measurement
- Wounds treated with any topical ointments or dressings other than hydrocolloid prior to LDI
- Not following the complete treatment schedule or missing some evaluations during the follow-up period
- Patient has any condition that seriously compromises the patient's ability to complete the study
Show all 12Show fewer
- Patient has participated in another study using an investigational drug within the previous 30 days
- Patient has one or more medical condition(s)that in the opinion of the investigator would make the patient an inappropriate candidate for this study
- The plastic surgeon decides that surgery is necessary due to unusual circumstances
- Patient wish to decline from the study
- No informed consent
- Full thickness burns
Trial locations and contacts
1 site in 1 country.
About this study
This study is to compare the treatment with two different silver-containing wound dressings: aquacel AG hydrofiber versus acticoat burn dressing.
- Being tested
- aquacel AG hydrofiber versus acticoat burn dressing
- Keywords
- Burn wounds - Silver Dressings - Bacterial Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aquacel AG hydrofiber versus acticoat burn dressingProcedure or surgery
Aquacel AG hydrofiber versus acticoat burn dressing will be compared.
| Study group | Role | What they receive |
|---|---|---|
| aquacel AG hydrofiber | Experimental | Not described Receives: Procedure: aquacel AG hydrofiber versus acticoat burn dressing |
| Acticoat burn dressing | Experimental | Not described Receives: Procedure: aquacel AG hydrofiber versus acticoat burn dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the efficacy of both wound dressings in controlling wound bioburden over a period of 21 days
Measured: Over a period of 21 days
Secondary outcomes (6)
Comparison of blood silver levels
Measured: Every week until woundhealing. In folluw-up: at 3, 6 and 12 months
Percentage of genetically-acquired resistance to silver
Measured: Once after wound closure.
Healing time comparison
Measured: Every 3 days until healing
Scar quality assessment
Measured: At 1, 3, 6 and 12 months after wound closure
Cost-effectiveness
Measured: Once after wound closure.
Health related quality of life
Measured: At 1, 3, 6 and 12 months after wound closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2006 (estimated)
- Study start1 Nov 2006
- Primary completion31 Jul 2010
- Study completion31 Jul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn Wounds - Partial Thickness (2nd Degree)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stan Monstrey, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00343824
- Sponsor's protocol ID
- 2006/224
- Status last verified
- Dec 2022
- First submitted
- 21 Jun 2006
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacterial Control in Partial Thickness Burns Using Silver-containing Wound Dressings
- ClinicalTrials.gov ID
- NCT00343824
- Acronym / sponsor ID
- 2006/224
- Keywords
- Burn wounds - Silver Dressings - Bacterial Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 1 Nov 2006 (actual)
- Primary completion
- 31 Jul 2010 (actual)
- Study completion
- 31 Jul 2010 (actual)
- First posted
- 23 Jun 2006 (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.
This study is to compare the treatment with two different silver-containing wound dressings: aquacel AG hydrofiber versus acticoat burn dressing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aquacel AG hydrofiber | Experimental | Procedure: aquacel AG hydrofiber versus acticoat burn dressing |
| Acticoat burn dressing | Experimental | Procedure: aquacel AG hydrofiber versus acticoat burn dressing |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Burn wounds with flux values, measured by Laser Doppler Imaging, corresponding with expected healing time between 7 and 21 days, flux values between 200 and 1000 (red-pink or pink-yellow-green colour)
- Wounds treated with a hydrocolloid paste prior to LDI
- Possibility to follow the complete treatment schedule until wound healing and participation on complete follow-up schedule
- Informed consent
- Partial thickness burns with TBSE < 40%
Key exclusion criteria (12 listed)
- Mean flux values < 200 or > 1000
- TBSA > 40%
- Impossibility to debride necrotic skin prior to LDI measurement
- Wounds treated with any topical ointments or dressings other than hydrocolloid prior to LDI
- Not following the complete treatment schedule or missing some evaluations during the follow-up period
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 |
|---|---|---|
| aquacel AG hydrofiber versus acticoat burn dressingAquacel AG hydrofiber versus acticoat burn dressing will be compared. | Procedure or surgery | Acticoat burn dressing, aquacel AG hydrofiber |
Primary outcome
Evaluation of the efficacy of both wound dressings in controlling wound bioburden over a period of 21 days
Time frame: Over a period of 21 days
6 secondary outcomes
Comparison of blood silver levels
Time frame: Every week until woundhealing. In folluw-up: at 3, 6 and 12 months
Percentage of genetically-acquired resistance to silver
Time frame: Once after wound closure.
Healing time comparison
Time frame: Every 3 days until healing
Scar quality assessment
Time frame: At 1, 3, 6 and 12 months after wound closure
Cost-effectiveness
Time frame: Once after wound closure.
Health related quality of life
Time frame: At 1, 3, 6 and 12 months after wound closure
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 21 Dec 2022.
- Website of the University Hospital GhentLink 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.
Stan Monstrey, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aquacel AG hydrofiber versus acticoat burn dressing in people with Burn Wounds - Partial Thickness (2nd Degree), run by University Hospital, Ghent at 1 site in Belgium.
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 5 inclusion and 12 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 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Evaluation of the efficacy of both wound dressings in controlling wound bioburden over a period of 21 days (time frame: Over a period of 21 days). 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 21 Dec 2022.