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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exufiber | Experimental | Treatment with Exufiber gelling fiber dressing |
|
| Exufiber Ag+ | Experimental | Treatment with Exufiber Ag+ silver-coated, gelling fiber dressing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exufiber | Device | A sterile nonwoven wound dressing made from highly absorbent PVA fibers. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Wound progression | A subjective measurement to determine wound progression since the last visit, determined by three outcome variables: Deteriorated No Change Improved | 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to discontinuation of study dressings | Measured by time (in days) from baseline to last clinical follow-up | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Burn Center, Valleywise Health | Phoenix | Arizona | 85008 | United States | ||
| Keck Medical Center of USC |
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Wound size and tissue type will be assessed by a single, blinded, third-party clinician. The clinician will use imaging software to measure the size of the wound and identify tissue types, from baseline to last clinical follow-up.
| Exufiber Ag+ |
| Device |
A sterile nonwoven wound dressing made from highly absorbent PVA fibers, and coated with silver sulphate. |
|
| 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. | 5 weeks |
| Wound Exudate | Evaluate the level of wound exudate, using the variables listed below: Dry Moist Wet Saturated Leaking | 5 weeks |
| Wound Maceration | Determine the presence of wound maceration, using the variables listed below: Yes No | 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 | 5 weeks |
| Blistering | Determine the presence of wound blistering, using the variables listed below: Yes No | 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 | 5 weeks |
| Exudate Nature | Determine the nature of wound exudate, using the variables listed below: Serous Serosanguinous Sanguineous Purulent | 5 weeks |
| Malodor | Determine the presence of wound malodor, using the variables listed below: None Slight Moderate Strong | 5 weeks |
| Burn odor | Determine the presence of burn odor, using the variables listed below: Yes No | 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 | 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 5 weeks |
| Los Angeles |
| California |
| 90033 |
| United States |
| MedStar Health Research Institute | Washington D.C. | District of Columbia | 20010 | United States |
| University of South Florida-Tampa General Hospital | Tampa | Florida | 33606 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Drexel Univerisity | Philadelphia | Pennsylvania | 19102 | United States |