The purpose of this trial is to assess the safety, tolerability and between-group effect size of STIMULAN VG (with debridement) and a course of systemic antibiotics to standard of care (debridement and systemic antibiotics only) for the treatment of osteomyelitis associated stage IV pressure ulcers.
Presenting with a Stage IV pressure ulcer requiring treatment of excision, bony debridement and flap coverage/primary closure.
Operative candidate for flap surgery or primary closure.
Presence of focal osteomyelitis as suggested by imaging to show extent of infection. Acceptable imaging techniques are Magnetic Resonance Imaging or CT scan.
Adults ≥ 18 years in age at the time of treatment.
None
Parallel
STIMULAN VG
Combination productInsertion of STIMULAN VG into the ulcer cavity prior to flap/primary closure.
Standard of Care
Procedure/SurgeryStandard of Care. Ulcer bursectomy, debridement and flap/primary closure. Peri-operative antibiotics.
Individual patient success and findings at the 8 week follow-up visit
An individual patient treatment will be considered a success if there is complete wound closure and healing at the surgical site at two consecutive visits 2 weeks apart.
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Biocomposites Ltd
Lead sponsor
MCRA
Collaborator
