Performance and Safety of Exufiber Ag+ and Exufiber on Partial Thickness Burns (NCT04839523) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Performance and Safety of Exufiber Ag+ and Exufiber on Partial Thickness Burns
United States44 participantsStarted 2021-03-10
Plain-language 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.
Who can participate
Age range4 Weeks
SexALL
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Inclusion criteria
✓. Signed informed consent
✓. Burn of thermal origin
✓. Patients presenting with partial thickness burns covering \< 5% TBSA for study treatment
✓. TBSA covered with any burn type is ≤15%, with a maximum of 10% being full thickness burns
✓. Clean wounds with ≤10% necrotic tissue
✓. Patients presenting with moderate to high exuding wounds
✓. Serous or Serosanguinous exudate
✓. Patient is not contraindicated for the dressing to which he/she is assigned
Exclusion criteria
✕. Electrical Burns
✕. Chemical Burns including acidic or basic sources
✕. Patients with delayed presentation for burn care (\>72 hours from time of injury)
✕. Before entry into the study, treatment to the study wound included an active agent that would confound study results, as determined by the Investigator
✕. Burns under study treatment transitioning to full thickness, or deep partial thickness burns requiring surgical treatment