An interventional study of Exufiber and Exufiber Ag+ in Partial-thickness Burn, sponsored by Molnlycke Health Care AB. Active, not recruiting at 6 sites in United States. Open to participants aged 4 Weeks and older. Per ClinicalTrials.gov, last updated 2024-11-12.
Sponsored by Molnlycke Health Care AB · Not applicable, Interventional, and Treatment
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.
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:
719 studies on the registry are indexed under Burns; 145 are open to participants now.
This study's enrollment of 44 is close to the median of 40 across 524 interventional studies indexed under Burns.
Browse Burns studies →Molnlycke Health Care AB is the lead sponsor of 58 studies on the registry; 7 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 3 (38%) have results posted.
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Exclusion Criteria:
Treatment with Exufiber gelling fiber dressing
Device: Exufiber
Treatment with Exufiber Ag+ silver-coated, gelling fiber dressing
Device: Exufiber Ag+
A sterile nonwoven wound dressing made from highly absorbent PVA fibers.
A sterile nonwoven wound dressing made from highly absorbent PVA fibers, and coated with silver sulphate.
Wound progression
A subjective measurement to determine wound progression since the last visit, determined by three outcome variables: Deteriorated No Change Improved
Time frame: 5 weeks
Time to discontinuation of study dressings
Measured by time (in days) from baseline to last clinical follow-up
Time frame: 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.
Time frame: 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.
Time frame: 5 weeks
Wound Exudate
Evaluate the level of wound exudate, using the variables listed below: Dry Moist Wet Saturated Leaking
Time frame: 5 weeks
Wound Maceration
Determine the presence of wound maceration, using the variables listed below: Yes No
Time frame: 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
Time frame: 5 weeks
Blistering
Determine the presence of wound blistering, using the variables listed below: Yes No
Time frame: 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
Time frame: 5 weeks
Exudate Nature
Determine the nature of wound exudate, using the variables listed below: Serous Serosanguinous Sanguineous Purulent
Time frame: 5 weeks
Malodor
Determine the presence of wound malodor, using the variables listed below: None Slight Moderate Strong
Time frame: 5 weeks
Burn odor
Determine the presence of burn odor, using the variables listed below: Yes No
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 5 weeks
Plan to share: No
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Molnlycke Health Care AB