NCT04839523

Performance and Safety of Exufiber Ag+ and Exufiber on Partial Thickness Burns

An Open, Non-comparative, Multi-center Investigation to Evaluate Performance and Safety of Exufiber Ag+ and Exufiber on Partial Thickness Burns

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Molnlycke Health Care AB · Industry
• Sex: All
• Age: 4 Weeks
• Healthy volunteers: Not accepted

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 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.

Conditions

• Partial-thickness Burn

Interventions

Type	Name	Description
DEVICE	Exufiber	A sterile nonwoven wound dressing made from highly absorbent PVA fibers.
DEVICE	Exufiber Ag+	A sterile nonwoven wound dressing made from highly absorbent PVA fibers, and coated with silver sulphate.

Timeline

• Start date: 2021-03-10
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2021-04-09
• Last updated: 2024-11-12

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study