Conditions: Pressure Ulcers Spinal Cord Injury
Keywords: Pressure Ulcers Spinal Cord Injury Healthpoint Xenaderm 011-101
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 19
Healthy volunteers: no

Brief summary:
The trial will compare the effects of 14 days treatment with HP011 101 versus Standard Care in subjects with Stage I or II pressure ulcers as a complication of spinal cord injury, measured as change from baseline in composite wound bed scores of the PUSH 3.0 tool.

Detailed description:

Arms:
arm 1: None arm 2: Standard Care at each site other than Xenaderm Ointment or other BCT-containing products

Interventions: intervention 1: HP011-101 (Xenaderm Ointment) intervention 2: Standard Care
Intervention descriptions: intervention 1: The test article will be applied at approximately the thickness of a dime twice daily, or more often if removed incidental to cleansing for 14 days treatment with HP011 101. intervention 2: No restrictions are placed on the nature of this care, except that it conform to the typical practices in place during the prior 3 months and that the regimen does not include the use of a BCT ointment (ointments containing Balsam Peru, castor oil and trypsin).

Protocol document: