The purpose of this European study is to demonstrate the safety and performance of the SurgiClot® dressing in the treatment of cancellous bone bleeding.
Patients who require surgery for iliac crest bone graft (ICBG), pelvic osteotomy or spinal fusion will be screened for this multicenter, prospective, non-randomized, open-label study. All qualified subjects will be treated with the SurgiClot® haemostatic dressing (a completely soluble dressing consisting of solid nanofibers of electrospun dextran with embedded lyophilized human fibrinogen and thrombin proteins). The safety and performance of the SurgiClot dressing will be evaluated in up to 40 subjects enrolled in Europe. Subjects will be followed for six weeks after the surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
30
haemostatic dressing
Helse Møre og Romsdal HF, Ålesund sjukehus
Ålesund, Norway
Helse Møre og Romsdal HF, Kristiansund sjukehus
Kristiansund, Norway
Salford Royal Infirmary
Salford, Manchester, United Kingdom
Jones & Hunt Orthopaedic Hospital
Oswestry, Shropshire, United Kingdom
The proportion of patients that achieve controlled haemostasis at the target bleeding site at 3 minutes
Time frame: 3 minutes
Incidence of device-related adverse events
Time frame: 6 weeks
Proportion of patients needing a repeat application of the dressing
Time frame: intra-operative
Proportion of repeat applications that achieve haemostasis
Time frame: intra-operative
Proportion of patients with negative immunogenicity response of coagulation factors: prothrombin time (PT)
Time frame: 6 weeks
Proportion of patients with negative immunogenicity response of coagulation factors: activated partial thromboplastin time (aPTT)
Time frame: 6 weeks
Proportion of patients with negative immunogenicity response of coagulation factors: international normalized ratio (INR)
Time frame: 6 weeks
Proportion of patients with negative immunogenicity response of coagulation factors: fibrinogen
Time frame: 6 weeks
Assess dressing characteristics of dissolvability via scales on a Product-Handling Characteristics Questionnaire
Time frame: intra-operative
Assess dressing characteristics of ease of preparation via scales on a Product-Handling Characteristics Questionnaire
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Doncaster Royal Infirmary
Doncaster, Yorkshire, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, United Kingdom
Castle Hill Hospital
Cottingham, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom
Time frame: intra-operative
Assess dressing characteristics of conformability via scales on a Product-Handling Characteristics Questionnaire
Time frame: intra-operative
Assess dressing characteristics of ease of use via scales on a Product-Handling Characteristics Questionnaire
Time frame: intra-operative
Mean volume of blood loss through the standard of care of the hospital
Time frame: 24 hours