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This study is being performed to assess the effectiveness of Altrazeal(R) Transforming Powder Dressing (TPD) in patients with partial thickness burns compared to the current standard of care (SOC) dressing. Adult men and women 18-65 years old who are hospitalized with an acute (meaning the burn injury occurred less than 36 hours prior to enrollment in the study) partial thickness burn wound, less than 20 percent of total body surface area may be considered. Subjects will be randomized in a 1:1 ratio to either SOC or TPD. Subjects will be followed for up to 28 days after enrollment.
Full description
This post-marketing study is being performed to assess the effectiveness of Altrazeal(R) Transforming Powder Dressing (TPD) in patients with partial thickness burns compared to the current standard of care (SOC) dressing for burn wounds. Adult men and women 18-65 years old who are hospitalized with an acute (meaning the burn injury occurred less than 36 hours prior to enrollment in the study) partial thickness burn wound, comprising less than 20 percent of total body surface area may be considered. Subjects will be randomized in a 1:1 ratio to either SOC or TPD. Subjects will be followed during hospitalization and then upon discharge from the hospital for up to 28 days after enrollment into the study. At each of the 8 study visits, the burn wound will be evaluated, photographed and measured. The wound will be cleaned and debrided, if needed, per usual standard burn care. A wound dressing will be applied using TPD or a typical SOC dressing. Wound healing and wound pain will be monitored at each visit, and the results of the two groups (TPD and SOC) will be compared to each other. A survey evaluating the satisfaction with the dressing received will be given at the end of the study, or when the wound heals, whichever comes first.
Enrollment
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Inclusion criteria
Exclusion criteria
Known allergy to TPD or its components
Infected wounds
Presence of any full thickness (third degree) burns
Electrical burns
Heavily draining burns due to underlying chronic lymphedema or other conditions
Concurrent clinical condition within the judgement of the clinician, pose a health risk to the patient, delay wound healing, or otherwise influence the outcome of the study.
History of poor wound healing and/or skin/immune system condition
Unwilling or not able to provide consent or comply with protocol or required visits
Developmental disability/significant psychological disorder which can impair the subjects ability to provide informed consent, or participate in the study protocol
Active alcohol or substance abuse
Primary purpose
Allocation
Interventional model
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60 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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