Wounds and InjuriesNCT03249909
Evaluation of Exufiber Ag+ and Other Gelling Fibre Dressings
A study testing Exufiber Ag+, Exufiber and Aquacel Ag Extra in people with Wounds and Injuries, run by Molnlycke Health Care AB at 8 sites in United States.
Trial summary
Investigate impact of gelling fiber dressings on handling exudate in medium to high exuding wounds Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds and Injuries
- What is being tested?
- Exufiber Ag+, Exufiber and Aquacel Ag Extra
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 8 sitesUnited States
- Study dates
- 11 Aug 2017to 19 Aug 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Signed Informed Consent Form
- Both gender ≥ 18 years old
- From Medium to High exuding wound
Who cannot join
- Known allergy or hypersensitivity to any of the treatment dressings
- Pregnant or lactating females
- Subjects with a target wound that is ≤1 cm2
- Subjects with a target wound that is a full thickness burn
- Subjects with a target wound that is a full thickness pressure ulcer
- Subjects with known immunodeficiency
Show all 14Show fewer
- Subject taking systemic antibiotics for wound infection
- Subject were the target wound is located on an infected limb interfered by minimal blood flow in the opinion of the investigator
- Subject with a target wound with unexplored enteric fistula
- Subjects who in the opinion of the investigator, will have problems following the protocol
- Subjects needing treatment with oxidizing agents such as hypochlorite solutions or hydrogen peroxide
- Previously enrolled in the present investigation
- Inclusion in other ongoing investigations at present that would preclude the subject from participating in this investigation as judged by the investigator
- Involvement in the planning and conduct of the clinical investigation
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Boise VA Medical Center (Boise VAMC) M
Boise, Idaho, 83702
Midwestern University
Glendale, Arizona, 85308
Northwell Health
Lake Success, New York, 11042
University of Miami
Miami, Florida, 33125
Serena Group Research Institute
Pittsburgh, Pennsylvania, 15222
Center for Clinical Research, Inc.
San Francisco, California, 94115
University of South Florida
Tampa, Florida, 33606
Jobst Vascular Institue (JVI)
Toledo, Ohio, 43606
About this study
Official title: A Clinical Investigation to Study the Effect of Exufiber Ag+ and Other Gelling Fibre Dressings on Wound Exudate and Bioburden in Medium to High Exuding Wounds
Investigate impact of gelling fiber dressings on handling exudate in medium to high exuding wounds
- Conditions
- Wounds and Injuries
- Being tested
- Exufiber Ag+, Exufiber, Aquacel Ag Extra
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exufiber Ag+Device
gelling fibre dressing with silver
ExufiberDevice
gelling fibre without silver
Aquacel Ag ExtraDevice
gelling fibre with silver
| Study group | Role | What they receive |
|---|---|---|
| Exufiber Ag + | Other | Gelling fibre dressing with silver to treat chronic wounds, acute wounds, and pressure ulcers. Data from these groups were analyzed separately with no comparative analysis. Receives: Device: Exufiber Ag+; Device: Exufiber; Device: Aquacel Ag Extra |
| Exufiber | Other | Gelling fibre dressing without silver to treat chronic wounds, acute wounds, and pressure ulcers. Data from these groups were analyzed separately with no comparative analysis. Receives: Device: Exufiber Ag+; Device: Exufiber; Device: Aquacel Ag Extra |
| Aquacel® Ag Extra | Other | Gelling fibre dressing with silver to treat chronic wounds, acute wounds, and pressure ulcers. Data from these groups were analyzed separately with no comparative analysis. Receives: Device: Exufiber Ag+; Device: Exufiber; Device: Aquacel Ag Extra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Exudate Status From Baseline to Last Visit
The primary endpoint measures exudate status based on dressing condition in categorical variables: Dry, Moist, Wet, Saturated, Leaking. Analysis of the change in exudate status (Decrease, Equal/Unchanged, Increase) from baseline to 4 weeks in the treatment groups was performed with a two-sided Sign test on the Intent To Treat (ITT) population at significance level 0.05.
If a subject had missing values at 4 weeks (Visit 5), last observation carried forward (LOCF) was applied from Visit 2 (1 week). Three subjects treated with Exufiber Ag+ did not have evaluable data: 2 of the subjects did not complete a Visit 2 (1 week) or later visits (both subjects with a chronic wound); 1 subject (with a chronic wound) only completed the investigation until Visit 2, however no exudate status data were reported at Visit 2 for that subject. One subject treated with Exufiber did complete a Visit 2 (1 week) or later visit.
Measured: 4 weeks (28 days) or earlier if the wound is dry or healed
Secondary outcomes (9)
4-Week Wound Status
The overall wound status was evaluated by the Nurse/Investigator in ordered, categorical variables (Stagnated, Aggravated, Same as baseline, Improved, Healed), and presented with number of participants at week 4 (28 days).
The total number (n) represents the total number of subjects included at the study visit; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat population with available data for this data point at Visit 5, or 4 weeks (28 days), is n=60 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra.
Measured: At 4 weeks (28 days)
Wound Area Reduction (mm^2)
Wound area was calculated as an ellipse, i.e. Area = (Longest length/2) x (Longest width/2) x π, and was measured by a third-party validated software system. To account for subjects requiring debridement, wound area presented here are pooled data for wounds not debrided and after debridement.
The total number (n) represents the total number of subjects included at the study visit with evaluable data; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing). Intent to Treat population with available data at Visit 5, or 4 weeks (28 days), or earlier if the wound is dry or healed, is n=59 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra.
Measured: Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed
Frequency of Dressing Changes Between Visits
Frequency of dressing change was evaluated by the Nurse/Investigator. Dressing changes for each dressing were to be performed at least weekly, in line with the IFU and schedule of assessment.
Values over 1 indicate dressing changes were required between study follow up visits, for any reason.
Measured: Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed
Tissue Type of Wound Bed
Measurement of tissue types were collected separately, including necrotic tissue, sloughy tissue, granulation tissue, and epithelialized tissue. The change in percent of tissue type from baseline to 4 weeks are presented with number and percentages.
The total number (n) represents the total number of subjects included at the study visit with evaluable data; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat population with available data at Visit 5, or 4 weeks (28 days), or earlier if the wound is dry or healed, is n=61 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra.
Measured: Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed
Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Malodour
Malodour was evaluated by the Nurse/Investigator in ordered categorical variables, None, Slight, Moderate, Strong. The Sign test was used for analysis of reported changes within groups from baseline to 4 weeks (Decrease, Equal/Unchanged, Increase), and described with number and percentages of reported changes.
The total number (n) represents the total number of subjects included at the study visit; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat (ITT) population with available data to analyze change from baseline to Visit 5, at 4 weeks (28 days), is n=61 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra.
Measured: Total treatment period of 4 weeks (28 days)
Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Redness/Irritation
Redness/Irritation under and outside the Primary dressing was evaluated by the Nurse/Investigator in and recorded as present (Yes) or not present (No). The Sign test was used for analysis of reported changes within groups from baseline to 4 weeks (Decrease, Equal/Unchanged, Increase), and presented with number and percentages of reported changes.
The total number (n) represents the total number of subjects included at the study visit; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat (ITT) population with available data to analyze change from baseline to Visit 5, at 4 weeks (28 days), is n=61 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra.
Measured: Total treatment period of 4 weeks (28 days)
Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Maceration
Maceration under and outside the Primary dressing was evaluated by the Nurse/Investigator in and recorded as present (Yes) or not present (No). The Sign test was used for analysis of reported changes within groups from baseline to 4 weeks (Decrease, Equal/Unchanged, Increase), and presented with number and percentages of reported changes.
The total number (n) represents the total number of subjects included at the study visit; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat (ITT) population with available data to analyze change from baseline to Visit 5, at 4 weeks (28 days), is n=61 for Exufiber Ag+; n=13 for Exufiber; n=12 for Aquacel Ag Extra.
Measured: Total treatment period of 4 weeks (28 days)
Handling and Technical Performance of the Dressing
Handling and technical performance of the dressings were evaluated by the Nurse/Investigator in ordered categorical variables, Very Poor, Poor, Good, Very Good, and NA. We have presented the percentage of study participants reported with the category variable, Very Good, for each question at 4 weeks (28 days).
The total number (n) represents the total number of subjects included at the study visit with evaluable data; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat population with available data at Visit 5, or 4 weeks (28 days), is n=63 for Exufiber Ag+; n=15 for Exufiber; n=16 for Aquacel Ag Extra.
Measured: At 4 weeks (28 days)
Comfort, Conformability, and Acceptability of the Dressings by Subject
Comfort, conformability, and acceptability of the dressings were evaluated by the Subject Participant in ordered categorical variables, Very Poor, Poor, Good, Very Good, and NA. We have presented the percentage of study participants reported with the category variable, Very Good, for each question at 4 weeks (28 days) or earlier if the wound dried or healed.
The total number (n) represents the total number of subjects included at the study visit with evaluable data; data were not always recorded for every subject, at every visit, for every data parameter (i.e. some data/answers are missing); Intent to Treat population with available data at Visit 5, or 4 weeks (28 days), is n=63 for Exufiber Ag+; n=15 for Exufiber; n=16 for Aquacel Ag Extra.
Measured: At 4 weeks (28 days) or earlier if the wound is dry or healed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start11 Aug 2017
- Primary completion19 Aug 2019
- Study completion19 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Wounds and InjuriesStudies 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
- Single group
- Model description
- Subjects were to be assigned in the following order: * Eligible Subjects 1 to 50 were to be assigned to the Exufiber Ag+ cohort * Eligible Subjects 51 to 65 were to be assigned to Exufiber * Eligible Subjects 66 to 85 were to be assigned to Aquacel Ag Extra * Eligible Subjects 86 to 105 were to be assigned to Exufiber Ag+ on eligible pressure ulcer subjects The statistical analysis of the groups treated will be analysed separately with the same statistical methods.
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molnlycke Health Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hadar Lev-Tov, MD, MAS, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03249909
- Sponsor's protocol ID
- Exufiber Ag+ 01
- Status last verified
- Mar 2019
- First submitted
- 6 Aug 2017
- Last updated
- 29 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- 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 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Investigation to Study the Effect of Exufiber Ag+ and Other Gelling Fibre Dressings on Wound Exudate and Bioburden in Medium to High Exuding Wounds
- ClinicalTrials.gov ID
- NCT03249909
- Acronym / sponsor ID
- Exufiber Ag+ 01
- Conditions
- Wounds and Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Study start
- 11 Aug 2017 (actual)
- Primary completion
- 19 Aug 2019 (actual)
- Study completion
- 19 Aug 2019 (actual)
- First posted
- 15 Aug 2017 (actual)
- Results
- Posted 29 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigate impact of gelling fiber dressings on handling exudate in medium to high exuding wounds
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Subjects were to be assigned in the following order: * Eligible Subjects 1 to 50 were to be assigned to the Exufiber Ag+ cohort * Eligible Subjects 51 to 65 were to be assigned to Exufiber * Eligible Subjects 66 to 85 were to be assigned to Aquacel Ag Extra * Eligible Subjects 86 to 105 were to be assigned to Exufiber Ag+ on eligible pressure ulcer subjects The statistical analysis of the groups treated will be analysed separately with the same statistical methods.
| Arm | Type | Receives |
|---|---|---|
| Exufiber Ag + | Other | Device: Exufiber Ag+, Device: Exufiber, Device: Aquacel Ag ExtraGelling fibre dressing with silver to treat chronic wounds, acute wounds, and pressure ulcers. Data from these groups were analyzed separately with no comparative analysis. |
| Exufiber | Other | Device: Exufiber Ag+, Device: Exufiber, Device: Aquacel Ag ExtraGelling fibre dressing without silver to treat chronic wounds, acute wounds, and pressure ulcers. Data from these groups were analyzed separately with no comparative analysis. |
| Aquacel® Ag Extra | Other | Device: Exufiber Ag+, Device: Exufiber, Device: Aquacel Ag ExtraGelling fibre dressing with silver to treat chronic wounds, acute wounds, and pressure ulcers. Data from these groups were analyzed separately with no comparative analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed Informed Consent Form
- Both gender ≥ 18 years old
- From Medium to High exuding wound
Key exclusion criteria (14 listed)
- Known allergy or hypersensitivity to any of the treatment dressings
- Pregnant or lactating females
- Subjects with a target wound that is ≤1 cm2
- Subjects with a target wound that is a full thickness burn
- Subjects with a target wound that is a full thickness pressure ulcer
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 |
|---|---|---|
| Exufiber Ag+gelling fibre dressing with silver | Device | Aquacel® Ag Extra, Exufiber, Exufiber Ag + |
| Exufibergelling fibre without silver | Device | Aquacel® Ag Extra, Exufiber, Exufiber Ag + |
| Aquacel Ag Extragelling fibre with silver | Device | Aquacel® Ag Extra, Exufiber, Exufiber Ag + |
Primary outcome
Change in Exudate Status From Baseline to Last Visit
Time frame: 4 weeks (28 days) or earlier if the wound is dry or healed
The primary endpoint measures exudate status based on dressing condition in categorical variables: Dry, Moist, Wet, Saturated, Leaking. Analysis of the change in exudate status (Decrease, Equal/Unchanged, Increase) from baseline to 4 weeks in the treatment groups was performed with a two-sided Sign test on the Intent To Treat (ITT) population at significance level 0.05. If a subject had missing values at 4 weeks (Visit 5), last observation carried forward (LOCF) was applied from Visit 2 (1 week). Three subjects treated with Exufiber Ag+ did not have evaluable data: 2 of the subjects did not complete a Visit 2 (1 week) or later visits (both subjects with a chronic wound); 1 subject (with a chronic wound) only completed the investigation until Visit 2, however no exudate status data were reported at Visit 2 for that subject. One subject treated with Exufiber did complete a Visit 2 (1 week) or later visit.
9 secondary outcomes
4-Week Wound Status
Time frame: At 4 weeks (28 days)
Wound Area Reduction (mm^2)
Time frame: Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed
Frequency of Dressing Changes Between Visits
Time frame: Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed
Tissue Type of Wound Bed
Time frame: Total treatment period of 4 weeks (28 days) or earlier if the wound is dry or healed
Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Malodour
Time frame: Total treatment period of 4 weeks (28 days)
Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Redness/Irritation
Time frame: Total treatment period of 4 weeks (28 days)
Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Maceration
Time frame: Total treatment period of 4 weeks (28 days)
Handling and Technical Performance of the Dressing
Time frame: At 4 weeks (28 days)
Comfort, Conformability, and Acceptability of the Dressings by Subject
Time frame: At 4 weeks (28 days) or earlier if the wound is dry or healed
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Wounds and Injuries
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Not yet recruiting
Safety Study of Microlyte DualGuard
Wound Closure, Wound Care
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
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.
Hadar Lev-Tov, MD, MAS principal investigator
University of Miami
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exufiber Ag+, Exufiber and Aquacel Ag Extra in people with Wounds and Injuries, run by Molnlycke Health Care AB at 8 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 3 inclusion and 14 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 29 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Yes. Results are posted in the registry (first posted 29 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Exudate Status From Baseline to Last Visit (time frame: 4 weeks (28 days) or earlier if the wound is dry or healed). 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 29 Sep 2020.