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Wound Dressing
Exufiber Dressings for Burns
N/A
Recruiting
Research Sponsored by Molnlycke Health Care AB
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
TBSA covered with any burn type is ≤15%, with a maximum of 10% being full thickness burns
Patients presenting with partial thickness burns covering < 5% TBSA for study treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 weeks
Awards & highlights
Study Summary
This trial will study the safety and performance of two types of dressings for moderate to high exuding partial thickness burns. Sixty-eight people will be treated over 5 weeks with dressing changes at each study visit.
Who is the study for?
This trial is for individuals with moderate to high exuding partial thickness burns covering less than 5% of their total body. They must have clean wounds, not be diabetic on insulin, and can't have used immunosuppressants or had certain treatments recently. Pregnant people and those unlikely to follow the study plan are excluded.Check my eligibility
What is being tested?
The trial tests two types of dressings: Exufiber Ag+ (with silver) and regular Exufiber, on patients with partial thickness burns. It aims to see how well these dressings work over a period of 5 weeks with dressing changes at each visit.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to dressing components or increased infection risk if the wound doesn't respond well to the treatment; however, specific side effects are not listed in this summary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
Less than 15% of my body is burned, with no more than 10% being severe burns.
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My burns cover less than 5% of my body.
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My wound is mostly clean with very little dead tissue.
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I have burns caused by heat.
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My wound leaks a moderate to high amount of fluid.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Wound progression
Secondary outcome measures
Bleeding at removal
Blistering
Burn odor
+26 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Exufiber Ag+Experimental Treatment1 Intervention
Treatment with Exufiber Ag+ silver-coated, gelling fiber dressing
Group II: ExufiberExperimental Treatment1 Intervention
Treatment with Exufiber gelling fiber dressing
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exufiber Ag+
2017
N/A
~110
Exufiber
2017
N/A
~150
Find a Location
Who is running the clinical trial?
Molnlycke Health Care ABLead Sponsor
54 Previous Clinical Trials
7,757 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not on high doses of steroids, less than 10mg of prednisolone a day.My burn has worsened to needing surgery under the study treatment.My wounds are dry.I have diabetes and need insulin.Less than 15% of my body is burned, with no more than 10% being severe burns.My burns cover less than 5% of my body.My wound is mostly clean with very little dead tissue.My burn wound is infected.I have burns caused by heat.I have been diagnosed with a serious condition like HIV/AIDS, cancer, or severe anemia.You have a known allergy or strong reaction to any of the ingredients in the study products.I haven't used immunosuppressants, radiation, or chemotherapy in the last 30 days.I have injuries from radiation exposure.I have suffered from electrical burns.I am a newborn.You have burns caused by chemicals that are either acidic or basic.Your wound was treated with a medication that could affect the results of the study.You have other medical conditions or diagnoses that make you more likely to get infections, as determined by the doctor running the study.My wound leaks a moderate to high amount of fluid.
Research Study Groups:
This trial has the following groups:- Group 1: Exufiber
- Group 2: Exufiber Ag+
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings currently available for prospective participants of this research?
"Affirmative. Clinicaltrials.gov has the information that this clinical trial is actively recruiting individuals, with its initial post dating back to March 10th 2021 and latest edit occurring on April 6th 2022. 68 patients must be recruited from one site in total."
Answered by AI
How many participants has the clinical trial accepted thus far?
"Affirmative, the information present on clinicaltrials.gov shows that this trial is actively recruiting individuals as of April 6th 2022. The study was initially published to the database on March 10th 2021 and requires 68 patients from 1 centre in order to be completed."
Answered by AI
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