BurnsNCT04412759
PORCINE XENOGRAFT OR MICROBIAL CELLULOSE IN THE TREATMENT OF PARTIAL THICKNESS BURNS
A study testing microbial cellulose in people with Burns and Burn Scar, run by University Hospital, Linkoeping at 1 site in Sweden.
Trial summary
The purpose of this study was to compare two wound dressing products for partial thickness burns in adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns, Burn Scar, Burn Second Degree
- What is being tested?
- microbial cellulose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSweden
- Study dates
- Jun 2016to Nov 2019
- 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
- Study participants admitted within 72 hours of injury
- partial-thickness burns requiring a temporary skin cover
- written informed consent
Who cannot join
- severe coexisting cutaneous trauma
- chronic or current skin disease,
- severe cognitive dysfunction or psychiatric disorder
- pregnant or breast feeding women were excluded.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
The Burn Centre at Linköping University Hospital,
Linköping, 58185
About this study
Official title: PORCINE XENOGRAFT OR MICROBIAL CELLULOSE IN THE TREATMENT OF PARTIAL THICKNESS BURNS - A RANDOMISED CLINICAL TRIAL
The purpose of this study was to compare two wound dressing products for partial thickness burns in adults.
Read the detailed description
After being informed about the study, all patients that had given written informed consent underwent screening. If eligible study participants were randomized to be treated wih either the standard dressing of care; pigskin or a microbial cellulose. Dressing were applied within 72 hours after burn injury. Evaluation was done in an open manner due to the specific characteristics of the dressings. Study particpants were followed weekly until complete wound closure and after that evaluated at 6 and 12 months after injruy for burn scar outcome.
- Conditions
- Burns, Burn Scar, Burn Second Degree
- Being tested
- microbial cellulose
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microbial celluloseOther
polymer dressing synthesized in abundance with Acetobacter Xylinum
| Study group | Role | What they receive |
|---|---|---|
| Porcine xenograft | No intervention | porcine xenograft derived from dermal porcine skin. Standard of care treatement for partila thickness burn at the specfic centre |
| Microbial cellulose | Experimental | Novel dressing consisting of a biopolymer spun by the bacteria Acetobacter xylinum (later removed). Receives: Other: microbial cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to complete healing of the burn
Healing time was calculated from the date of injury to the date when the wound bed was assessed as completely (100 %) re-epithelialized, with no need for further dressing changes other than protection against shearing according to the treating physician.
Measured: Evaluated at each visit (1-3 times per week) from admission until complete healing, up to 6 months
Secondary outcomes (4)
Burn wound infection
Wound infections were diagnosed (by the burn surgeon) if they fulfilled at least two of the following criteria:
(based on the American Burn Association definition of burn wound infection)
- Clinical signs such as localised pain and swelling, spreading erythema, and heat at the affected site.
- Positive bacterial culture growth of the surface wound swab.
- Signs of systemic infection indicated by a rise in CRP concentration (reference range < 10 mg/L for capillary sampling) together with increased body temperature where other sources of infection have been excluded.
Measured: Evaluated at each visit (1-3 times per week) from admission until complete healing, up to 6 months
Burn wound pain
The patients were asked to estimate the burn wound pain at rest, during activity, and during dressing changes using a numerical rating scale (NRS) where 0 indicated no pain and 10 the worst pain ever imaginable.
Measured: Evaluated at each visit (1-3 times per week) from admission until complete healing, up to 6 months
Duration of hospital stay (LOS)
All patients hospitalized for their burns were monitored by the study nurse and the day of discharge was noted in the CRF. Any readmission after initial discharge was also noted and included in the total length of stay.
Measured: From admission until discharge, up to 6 months
Burn scar outcome
Burn scar outcome was evaluated using the Patient Observer Scar Assessment Scale (POSAS). The scale includes two separate subscales, The Observer Sscale, used by an experienced burn occupational therapist and the Patient Sscale, used by the study participants.
Measured: Evaluated at six and 12 months after injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study startJun 2016
- Primary completionNov 2018
- Study completionNov 2019
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Folke Sjoberg, University Hospital, Linkoeping
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04412759
- Sponsor's protocol ID
- MC-2015
- Status last verified
- May 2020
- First submitted
- 29 May 2020
- Last updated
- 2 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PORCINE XENOGRAFT OR MICROBIAL CELLULOSE IN THE TREATMENT OF PARTIAL THICKNESS BURNS - A RANDOMISED CLINICAL TRIAL
- ClinicalTrials.gov ID
- NCT04412759
- Acronym / sponsor ID
- MC-2015
- Conditions
- Burns, Burn Scar, Burn Second Degree
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 2 Jun 2020 (actual)
- 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 was to compare two wound dressing products for partial thickness burns in adults.
Detailed description
After being informed about the study, all patients that had given written informed consent underwent screening. If eligible study participants were randomized to be treated wih either the standard dressing of care; pigskin or a microbial cellulose. Dressing were applied within 72 hours after burn injury. Evaluation was done in an open manner due to the specific characteristics of the dressings. Study particpants were followed weekly until complete wound closure and after that evaluated at 6 and 12 months after injruy for burn scar outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Porcine xenograft | No intervention | –porcine xenograft derived from dermal porcine skin. Standard of care treatement for partila thickness burn at the specfic centre |
| Microbial cellulose | Experimental | Other: microbial celluloseNovel dressing consisting of a biopolymer spun by the bacteria Acetobacter xylinum (later removed). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Study participants admitted within 72 hours of injury
- partial-thickness burns requiring a temporary skin cover
- written informed consent
Key exclusion criteria (4 listed)
- severe coexisting cutaneous trauma
- chronic or current skin disease,
- severe cognitive dysfunction or psychiatric disorder
- pregnant or breast feeding women were excluded.
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 |
|---|---|---|
| microbial cellulosepolymer dressing synthesized in abundance with Acetobacter Xylinum | Other | Microbial cellulose |
Primary outcome
Time to complete healing of the burn
Time frame: Evaluated at each visit (1-3 times per week) from admission until complete healing, up to 6 months
Healing time was calculated from the date of injury to the date when the wound bed was assessed as completely (100 %) re-epithelialized, with no need for further dressing changes other than protection against shearing according to the treating physician.
4 secondary outcomes
Burn wound infection
Time frame: Evaluated at each visit (1-3 times per week) from admission until complete healing, up to 6 months
Burn wound pain
Time frame: Evaluated at each visit (1-3 times per week) from admission until complete healing, up to 6 months
Duration of hospital stay (LOS)
Time frame: From admission until discharge, up to 6 months
Burn scar outcome
Time frame: Evaluated at six and 12 months after injury
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 Jun 2020.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing microbial cellulose in people with Burns and Burn Scar, run by University Hospital, Linkoeping at 1 site in Sweden.
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 3 inclusion and 4 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 Jun 2020. 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 Sweden. 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?
Time to complete healing of the burn (time frame: Evaluated at each visit (1-3 times per week) from admission until complete healing, up to 6 months). 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 Jun 2020.