This is a prospective, single arm, multicentre, multispecialty, post market, clinical study evaluating SURGICEL Powder as an adjunct to achieve haemostasis (control bleeding) when conventional methods of control are impractical or ineffective during surgery (open, laparoscopic or thoracoscopic) in adult subjects (18 years or older). After application of SURGICEL Powder, the Target Bleeding Site (TBS) will be assessed for haemostasis (no detectable bleeding) at 3, 5, and 10 minutes from application and prior to initiation of closure. All enrolled subjects will be followed post-operatively through discharge and again at 30 days and 6 months post-surgery via phone call or office visit.
This is an open label, prospective, single arm, multicentre, multispecialty, post-marketing clinical study evaluating SURGICEL Powder as an adjunct to achieve haemostasis in the control of capillary, venous, and small arterial haemorrhage when ligation or other conventional methods of control are impractical or ineffective during surgery (open, laparoscopic or thoracoscopic) in adult subjects (18 years or older). Prospective subjects will be informed about the nature of the research, given the informed consent form (ICF) to read, and, if he/she understands the content, will be asked to provide consent by signing the ICF. Screening and enrolment will continue until at least 100 evaluable subjects from approximately eight (8) investigational sites, with an appropriate mild or moderate Target Bleeding Site (TBS) are included into the study. The TBS will be the only region evaluated for the primary endpoint and all secondary effectiveness endpoints. All enrolled subjects will be followed post-operatively through discharge, and via phone call or office visit at 30 days (+14 days) post-surgery. In addition, all enrolled subjects will receive a 6-month (+/-30 days) follow-up phone call or office visit to assess the occurrence of any serious adverse event (SAE) requiring surgical intervention and assessed as possibly related or related to the study treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
103
SURGICEL Powder is a topical absorbable hemostatic treatment made of oxidized regenerated cellulose (ORC) - plant material
Ziekenhuis Oost Limburg
Genk, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
NHS Lothian (Western General Hospital)
Edinburgh, Lothian, United Kingdom
Cambridge University Hospitals NHS Trust (Addenbrooke's Hospital)
Cambridge, United Kingdom
Golden Jubilee National Hospital
Clydebank, United Kingdom
Leeds Teaching Hospitals NHS Trust (St James's University Hospital)
Leeds, United Kingdom
Newcastle upon Tyne NHS Foundation Trust (Freeman Hospital)
Newcastle upon Tyne, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
Haemostatic Success at 5 Minutes
Proportion of subjects achieving haemostatic success at 5 minutes following application of SURGICEL Powder with no rebleeding requiring additional treatment at the Target Bleeding Site (TBS) any time prior to initiation of final fascial closure
Time frame: From application of SURGICEL Powder to 5 minutes after application
Haemostatic Success at 3 Minutes
Proportion of subjects achieving haemostatic success at 3 minutes following application of SURGICEL Powder with no rebleeding requiring additional treatment at the TBS any time prior to initiation of final fascial closure
Time frame: From application of SURGICEL Powder to 3 minutes after application
Haemostatic Success at 10 Minutes
Proportion of subjects achieving haemostatic success at 10 minutes following the application of SURGICEL Powder with no rebleeding that requires additional treatment at the TBS any time prior to initiation of final fascial closure
Time frame: From application of SURGICEL Powder to 10 minutes after application
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.