Partial-thickness BurnNCT04839523
Performance and Safety of Exufiber Ag+ and Exufiber on Partial Thickness Burns
A study testing Exufiber and Exufiber Ag+ in people with Partial-thickness Burn, run by Molnlycke Health Care AB at 6 sites in United States.
Trial summary
This a multi-center, open label, non-comparative, study that will evaluate the clinical safety and performance of Exufiber Ag+ and Exufiber dressings, separately, when used as intended in moderate to high exuding partial thickness burns (PTBs) through assessment of wound progression from baseline to the Subject's last… Read more about this study
- Who is it for?
- Ages 4 weeks and older
- Conditions the study is for
- Partial-thickness Burn
- What is being tested?
- Exufiber and Exufiber Ag+
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 6 sitesUnited States
- Study dates
- 10 Mar 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Signed informed consent
- Burn of thermal origin
- Patients presenting with partial thickness burns covering < 5% TBSA for study treatment
- TBSA covered with any burn type is ≤15%, with a maximum of 10% being full thickness burns
- Clean wounds with ≤10% necrotic tissue
- Patients presenting with moderate to high exuding wounds
- Serous or Serosanguinous exudate
- Patient is not contraindicated for the dressing to which he/she is assigned
Who cannot join
- Electrical Burns
- Chemical Burns including acidic or basic sources
- Ionizing radiation injuries
- Dry wounds
- Neonates
- Patients with delayed presentation for burn care (>72 hours from time of injury)
Show all 19Show fewer
- Before entry into the study, treatment to the study wound included an active agent that would confound study results, as determined by the Investigator
- Burns under study treatment transitioning to full thickness, or deep partial thickness burns requiring surgical treatment
- Clinically infected burn
- Patients with insulin dependent diabetes mellitus
- Patients treated with systemic glucocorticosteroids, except patients taking occasional doses or doses less than 10mg prednisolone per day or equivalent
- Patients who have used immunosuppressive agents, radiation or chemotherapy within past 30 days
- Known allergy/hypersensitivity to any of the components of the investigation products
- History of comorbid conditions or diagnoses associated with higher risk of infection as determined by the Investigator
- Diagnosed underlying disease(s) (e.g. HIV/AIDS, cancer, severe anemia)
- Patients that are not expected to comply with the investigation due to physical and/or mental conditions
- Pregnancy
- Participation in other clinical investigation(s) within 1 month prior to start of the investigation
- Previously enrolled in this investigation
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Keck Medical Center of USC
Los Angeles, California, 90033
Drexel Univerisity
Philadelphia, Pennsylvania, 19102
Arizona Burn Center, Valleywise Health
Phoenix, Arizona, 85008
University of South Florida-Tampa General Hospital
Tampa, Florida, 33606
MedStar Health Research Institute
Washington D.C., District of Columbia, 20010
About this study
Official title: An Open, Non-comparative, Multi-center Investigation to Evaluate Performance and Safety of Exufiber Ag+ and Exufiber on Partial Thickness Burns
This a multi-center, open label, non-comparative, study that will evaluate the clinical safety and performance of Exufiber Ag+ and Exufiber dressings, separately, when used as intended in moderate to high exuding partial thickness burns (PTBs) through assessment of wound progression from baseline to the Subject's last clinical follow-up visit.
Sixty-eight (68) eligible subjects, with moderate to high exuding partial-thickness burns, will be selected for treatment with either Exufiber Ag+ silver-coated gelling dressing, or Exufiber gelling dressing. The study will last 5 weeks, with a requirement of 5 study visits in total, including dressing changes at each study visit.
Read the detailed description
This is a multi-center study taking place in the United States, and conducted at 3-4 sites/locations. It is designed as an open, non-comparative study to test the safety and performance of Exufiber Ag+ and Exufiber in managing burn healing.
The primary objective of this study is to evaluate the clinical safety and performance of all study dressings, separately, when used as intended in moderate to high exuding partial thickness burns (PTBs) through assessment of wound progression from baseline to the Subject's last clinical follow-up visit. The dressings are intended to promote healing through the management of the wound environment.
Sixty-eight (68) subjects with partial thickness burns will be treated with either Exufiber Ag+ (34 subjects) or Exufiber (34 subjects) primary dressings, at the discretion of the Investigator. Secondary dressings should be non-adherent, non-antimicrobial dressings (local treatment praxis).
Each Subject will be evaluated at five (5) planned study visits for a maximum total treatment period of up to 21 days, unless the burn heals.
Visit 1 is a baseline visit to enroll Subjects and determine burn extent. Each Subject will be assigned to either Exufiber Ag+ or Exufiber primary dressings and treated according to the Instructions for Use (IFU) and the local clinical routine.
Visit 2 is a Confirmation Visit at up to 3 days, where the Investigator will confirm the burn meets study eligibility, and has not progressed to a full-thickness burn.
Visits 3, 4, and 5 are follow-up visits at days 7, 14, and 21, respectively, from the date of the primary dressing application.
At each follow-up visit the Subject will return to the clinic for evaluation and primary dressing change. Wound progression will be determined by the Investigator at each study visit and measured by three outcome variables (Deteriorated, No Change, Improved). Images of the wound at each follow up visit will be analyzed to determine changes in wound size.
Secondary endpoints will be collected identically at each visit at each clinical site to assess safety and performance of the dressings. The secondary objectives are:
- To evaluate time to discontinuation of study dressings from baseline to the last clinical follow-up visit, up to 21 days.
- To evaluate clinical outcomes of the study wound from baseline to the last clinical visit up to 21 days.
- To evaluate epithelization from baseline to the last clinical follow-up visit up to 21 days based on digital photo imaging software measurements.
- To evaluate a change in wound size from baseline to the last clinical follow-up visit up to 21 days based on digital photo and imaging software measurements.
- To evaluate healing status, including exudate levels, infection status, and proportion of burn healed, by clinician's visual judgement, at Confirmation Visit (up to 72 hours) and at each clinic follow-up visit, up to 21 days.
- To evaluate Subject-reported pain at application, during wear, and at dressing changes through questionnaires at each clinic follow-up visit up to 21 days.
- To evaluate treatment and dressing selections, including type and quantity, at application and at each clinic follow-up visit up to 21 days.
- To evaluate clinician handling of the dressing at application and at every dressing change performed at the clinic, from baseline and at each follow-up visit up to 21 days.
- To evaluate clinician assessment of the dressing at application and at every dressing change performed at the clinic, from baseline and at each follow-up visit up to 21 days.
- Conditions
- Partial-thickness Burn
- Being tested
- Exufiber, Exufiber Ag+
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExufiberDevice
A sterile nonwoven wound dressing made from highly absorbent PVA fibers.
Exufiber Ag+Device
A sterile nonwoven wound dressing made from highly absorbent PVA fibers, and coated with silver sulphate.
| Study group | Role | What they receive |
|---|---|---|
| Exufiber | Experimental | Treatment with Exufiber gelling fiber dressing Receives: Device: Exufiber |
| Exufiber Ag+ | Experimental | Treatment with Exufiber Ag+ silver-coated, gelling fiber dressing Receives: Device: Exufiber Ag+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound progression
A subjective measurement to determine wound progression since the last visit, determined by three outcome variables:
Deteriorated
No Change
Improved
Measured: 5 weeks
Secondary outcomes (29)
Time to discontinuation of study dressings
Measured by time (in days) from baseline to last clinical follow-up
Measured: 5 weeks
Wound Size
Wound size (measured in inches or centimeters), at each study visit, from baseline to last clinical follow-up, using planimetry software to obtain measurements from digital photographs. Measurements to include length, width, and depth.
Measured: 5 weeks
Re-epithelialization of wound
A measure of re-epithelization tissue, as a percentage of wound, from baseline to last clinical follow-up, using planimetry software to obtain measurements from digital photographs.
Measured: 5 weeks
Wound Exudate
Evaluate the level of wound exudate, using the variables listed below:
Dry
Moist
Wet
Saturated
Leaking
Measured: 5 weeks
Wound Maceration
Determine the presence of wound maceration, using the variables listed below:
Yes
No
Measured: 5 weeks
Proportion of Burn Healed
Evaluate the proportion of the burn that is healed, by clinician judgement, using the variables listed below:
No healing
0-30% healed
31-70% healed
71-99% healed
100% healed
Measured: 5 weeks
Blistering
Determine the presence of wound blistering, using the variables listed below:
Yes
No
Measured: 5 weeks
Wound Redness/Irritation peri-wound skin
Determine the presence of redness and irritation on the peri-wound skin, using the variables listed below:
Yes
No
Measured: 5 weeks
Exudate Nature
Determine the nature of wound exudate, using the variables listed below:
Serous
Serosanguinous
Sanguineous
Purulent
Measured: 5 weeks
Malodor
Determine the presence of wound malodor, using the variables listed below:
None
Slight
Moderate
Strong
Measured: 5 weeks
Burn odor
Determine the presence of burn odor, using the variables listed below:
Yes
No
Measured: 5 weeks
Local infection
Determine the presence of signs of local wound infection, using the variables listed below:
New / Increasing Pain
Delayed / Stalled Healing
Purulent discharge
Erythema
Local Warmth
Exudation
Odor
Pyrexia
Induration
Leukocytosis
Edema / Swelling
Eschar
Measured: 5 weeks
Subject pain
Measured at dressing application, change, and removal, using a patient reported outcome questionnaire that is used to evaluate pain intensity on a validated scale from 0-10. A higher score correlates with greater experienced pain.
Measured: 5 weeks
Dressing Adherence
Subjective measurement to asses performance of the primary dressing and its adherence to the wound bed, using the variables listed below:
Yes
No
Measured: 5 weeks
Rewetting
Subjective measurement to asses performance of the primary dressing and the need for re-wetting prior to removal, using the variables listed below:
Yes
No
Measured: 5 weeks
Dressing ability to rehydrate
Subjective measurement to asses performance of the primary dressing and its ability to rehydrate the wound, using the variables listed below:
Very poor
Poor
Good
Very good
N/A
Measured: 5 weeks
Dressing ability to retain exudate
Subjective measurement to asses performance of the primary dressing and its ability to retain wound exudate, using the variables listed below:
Very poor
Poor
Good
Very good
N/A
Measured: 5 weeks
Dressing ability to absorb blood
Subjective measurement to asses performance of the primary dressing and its ability to absorb blood, using the variables listed below:
Very poor
Poor
Good
Very good
N/A
Measured: 5 weeks
Dressing ability to retain slough
Subjective measurement to asses performance of the primary dressing and its ability to retain slough, using the variables listed below:
Very poor
Poor
Good
Very good
N/A
Measured: 5 weeks
Dressing ability to clean wound bed
Subjective measurement to asses performance of the primary dressing and its ability to clean the wound bed, using the variables listed below:
Very poor
Poor
Good
Very good
N/A
Measured: 5 weeks
Dressing ability to retain gelling properties
Subjective measurement to asses performance of the primary dressing and its ability to retain its gelling properties, using the variables listed below:
Very poor
Poor
Good
Very good
N/A
Measured: 5 weeks
Dressing ability to retain balanced moist environment
Subjective measurement to asses performance of the primary dressing and its ability to retain a balanced moist environment, using the variables listed below:
Very poor
Poor
Good
Very good
N/A
Measured: 5 weeks
Dressing conformability
Subjective measurement to assess performance of the primary dressing and its ability to conform, using the variables listed below:
Very poor
Poor
Good
Very good
N/A
Measured: 5 weeks
Dressing flexibility
Subjective measurements to assess performance of the primary dressing and its flexibility, using the variables listed below:
Very poor
Poor
Good
Very good
N/A
Measured: 5 weeks
Ease of dressing application
Subjective measurement to assess the handling of the primary dressing and ease of dressing application, using the variables listed below:
Very poor
Poor
Good
Very good
N/A
Measured: 5 weeks
Ease of dressing removal with and without moistening
Subjective measurement to assess the handling of the primary dressing and ease of removal with and without moistening, using the variables listed below:
Very poor
Poor
Good
Very good
N/A
Measured: 5 weeks
Dressing removal in one piece
Subjective measurement to assess the handling of primary dressing and its ability to be removed in one piece, using the variables listed below:
Yes
No
Measured: 5 weeks
Residuals of dressing material in the wound or surrounding skin
Subjective measurement to assess presence of primary dressing residuals in the wound or surrounding skin at the time of removal, using the variables listed below:
Yes
No
Measured: 5 weeks
Bleeding at removal
Subjective measurement to assess presence of bleeding at the time of primary dressing removal, using the variables listed below:
Yes
No
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start10 Mar 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial-thickness BurnStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molnlycke Health Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04839523
- Sponsor's protocol ID
- PTB01
- Status last verified
- Nov 2024
- First submitted
- 5 Apr 2021
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Non-comparative, Multi-center Investigation to Evaluate Performance and Safety of Exufiber Ag+ and Exufiber on Partial Thickness Burns
- ClinicalTrials.gov ID
- NCT04839523
- Acronym / sponsor ID
- PTB01
- Conditions
- Partial-thickness Burn
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 9 Apr 2021 (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.
This a multi-center, open label, non-comparative, study that will evaluate the clinical safety and performance of Exufiber Ag+ and Exufiber dressings, separately, when used as intended in moderate to high exuding partial thickness burns (PTBs) through assessment of wound progression from baseline to the Subject's last clinical follow-up visit.
Sixty-eight (68) eligible subjects, with moderate to high exuding partial-thickness burns, will be selected for treatment with either Exufiber Ag+ silver-coated gelling dressing, or Exufiber gelling dressing. The study will last 5 weeks, with a requirement of 5 study visits in total, including dressing changes at each study visit.
Detailed description
This is a multi-center study taking place in the United States, and conducted at 3-4 sites/locations. It is designed as an open, non-comparative study to test the safety and performance of Exufiber Ag+ and Exufiber in managing burn healing.
The primary objective of this study is to evaluate the clinical safety and performance of all study dressings, separately, when used as intended in moderate to high exuding partial thickness burns (PTBs) through assessment of wound progression from baseline to the Subject's last clinical follow-up visit. The dressings are intended to promote healing through the management of the wound environment.
Sixty-eight (68) subjects with partial thickness burns will be treated with either Exufiber Ag+ (34 subjects) or Exufiber (34 subjects) primary dressings, at the discretion of the Investigator. Secondary dressings should be non-adherent, non-antimicrobial dressings (local treatment praxis).
Each Subject will be evaluated at five (5) planned study visits for a maximum total treatment period of up to 21 days, unless the burn heals.
Visit 1 is a baseline visit to enroll Subjects and determine burn extent. Each Subject will be assigned to either Exufiber Ag+ or Exufiber primary dressings and treated according to the Instructions for Use (IFU) and the local clinical routine.
Visit 2 is a Confirmation Visit at up to 3 days, where the Investigator will confirm the burn meets study eligibility, and has not progressed to a full-thickness burn.
Visits 3, 4, and 5 are follow-up visits at days 7, 14, and 21, respectively, from the date of the primary dressing application.
At each follow-up visit the Subject will return to the clinic for evaluation and primary dressing change. Wound progression will be determined by the Investigator at each study visit and measured by three outcome variables (Deteriorated, No Change, Improved). Images of the wound at each follow up visit will be analyzed to determine changes in wound size.
Secondary endpoints will be collected identically at each visit at each clinical site to assess safety and performance of the dressings. The secondary objectives are:
- To evaluate time to discontinuation of study dressings from baseline to the last clinical follow-up visit, up to 21 days.
- To evaluate clinical outcomes of the study wound from baseline to the last clinical visit up to 21 days.
- To evaluate epithelization from baseline to the last clinical follow-up visit up to 21 days based on digital photo imaging software measurements.
- To evaluate a change in wound size from baseline to the last clinical follow-up visit up to 21 days based on digital photo and imaging software measurements.
- To evaluate healing status, including exudate levels, infection status, and proportion of burn healed, by clinician's visual judgement, at Confirmation Visit (up to 72 hours) and at each clinic follow-up visit, up to 21 days.
- To evaluate Subject-reported pain at application, during wear, and at dressing changes through questionnaires at each clinic follow-up visit up to 21 days.
- To evaluate treatment and dressing selections, including type and quantity, at application and at each clinic follow-up visit up to 21 days.
- To evaluate clinician handling of the dressing at application and at every dressing change performed at the clinic, from baseline and at each follow-up visit up to 21 days.
- To evaluate clinician assessment of the dressing at application and at every dressing change performed at the clinic, from baseline and at each follow-up visit up to 21 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exufiber | Experimental | Device: ExufiberTreatment with Exufiber gelling fiber dressing |
| Exufiber Ag+ | Experimental | Device: Exufiber Ag+Treatment with Exufiber Ag+ silver-coated, gelling fiber dressing |
Who may qualify
- Ages
- 4 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Signed informed consent
- Burn of thermal origin
- Patients presenting with partial thickness burns covering < 5% TBSA for study treatment
- TBSA covered with any burn type is ≤15%, with a maximum of 10% being full thickness burns
- Clean wounds with ≤10% necrotic tissue
Key exclusion criteria (19 listed)
- Electrical Burns
- Chemical Burns including acidic or basic sources
- Ionizing radiation injuries
- Dry wounds
- Neonates
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 |
|---|---|---|
| ExufiberA sterile nonwoven wound dressing made from highly absorbent PVA fibers. | Device | Exufiber |
| Exufiber Ag+A sterile nonwoven wound dressing made from highly absorbent PVA fibers, and coated with silver sulphate. | Device | Exufiber Ag+ |
Primary outcome
Wound progression
Time frame: 5 weeks
A subjective measurement to determine wound progression since the last visit, determined by three outcome variables: Deteriorated No Change Improved
29 secondary outcomes
Time to discontinuation of study dressings
Time frame: 5 weeks
Wound Size
Time frame: 5 weeks
Re-epithelialization of wound
Time frame: 5 weeks
Wound Exudate
Time frame: 5 weeks
Wound Maceration
Time frame: 5 weeks
Proportion of Burn Healed
Time frame: 5 weeks
Blistering
Time frame: 5 weeks
Wound Redness/Irritation peri-wound skin
Time frame: 5 weeks
Exudate Nature
Time frame: 5 weeks
Malodor
Time frame: 5 weeks
Burn odor
Time frame: 5 weeks
Local infection
Time frame: 5 weeks
Subject pain
Time frame: 5 weeks
Dressing Adherence
Time frame: 5 weeks
Rewetting
Time frame: 5 weeks
Dressing ability to rehydrate
Time frame: 5 weeks
Dressing ability to retain exudate
Time frame: 5 weeks
Dressing ability to absorb blood
Time frame: 5 weeks
Dressing ability to retain slough
Time frame: 5 weeks
Dressing ability to clean wound bed
Time frame: 5 weeks
Dressing ability to retain gelling properties
Time frame: 5 weeks
Dressing ability to retain balanced moist environment
Time frame: 5 weeks
Dressing conformability
Time frame: 5 weeks
Dressing flexibility
Time frame: 5 weeks
Ease of dressing application
Time frame: 5 weeks
Ease of dressing removal with and without moistening
Time frame: 5 weeks
Dressing removal in one piece
Time frame: 5 weeks
Residuals of dressing material in the wound or surrounding skin
Time frame: 5 weeks
Bleeding at removal
Time frame: 5 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- 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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exufiber and Exufiber Ag+ in people with Partial-thickness Burn, run by Molnlycke Health Care AB at 6 sites in United States.
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 8 inclusion and 19 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: under way, not looking for participants, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
Wound progression (time frame: 5 weeks). 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 12 Nov 2024.