SURGICEL® Powder in Controlling Mild or Moderate Parenchymal or Soft Tissue Intraoperative Bleeding in Adult Subjects

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective, Clinical Study Evaluating the Safety and Haemostatic Effectiveness of SURGICEL® Powder, in Mild or Moderate Parenchymal or Soft Tissue Bleeding During General, Gynaecological, Urological, and Cardiothoracic Surgery

Conditions
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Hemorrhage

Intervention / Treatment
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* Device: SURGICEL Powder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pre-operative: Adult subjects ≥ 18 years requiring elective/non-emergent open or laparoscopic general, gynaecological, cardiothoracic, or urological surgical procedures; Subject or authorised representative has signed the approved Informed Consent; Subject(s) whose International Normalised Ratio is <1.5 within 24 hours of surgery. Intra-operative: Presence of an appropriate TBS identified intra-operatively by the surgeon; Subject(s) undergoing cardiothoracic surgery with anticoagulation must have anticoagulation reversed prior to TBS identification and treatment. Exclusion Criteria: Pre-operative: Female subjects who are pregnant or nursing; Subject on anticoagulation medication (with exception of aspirin) prior to surgery. Washout periods for respective medications must be observed. If information is not readily available within the Instructions for Use (IFU), a conservative approach should be taken and intravenous heparin stopped 12 hours prior to surgery and 2 days prior for oral medication; Subject on antiplatelet/P2Y12 inhibitors medication prior to surgery. Platelet recovery times for respective medication must be observed. If information is not readily available within the IFU, a conservative approach should be taken and medication stopped 5 days prior to surgery. Subject is currently participating or plans to participate in any other investigational device or drug without prior approval from the Sponsor; Subjects who are known, current alcohol and/or drug abusers; Subjects with any pre-operative findings identified by the surgeon that may preclude conduct of the study procedure. Intra-operative: Subjects with any intra-operative findings identified by the surgeon that may preclude the use of study product; Subject with TBS in an actively infected field [Class III Contaminated or Class IV Dirty or Infected (see Appendix 2 in in Section 15.2)]; TBS is on arteries or veins where application of SURGICEL Powder would present a risk of introducing the study product into an open blood vessel; Major arterial or venous bleeding or major defects in arteries and veins; TBS where silver nitrate or any other escharotic chemicals have been applied; TBS is in, around, or in proximity to foramina in bone, or areas of bony confine, the spinal cord, or optic nerve and chiasm; TBS in urological procedures where plugging (blocking) of the urethra, ureter or a catheter is possible by the study product.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: SURGICEL Powder - Single arm<br>Single arm clinical trial where all qualified subjects will be treated SURGICEL Powder | Device: SURGICEL Powder<br>* SURGICEL Powder is a topical absorbable hemostatic treatment made of oxidized regenerated cellulose (ORC) - plant material<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | From application of SURGICEL Powder to 5 minutes after application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | From application of SURGICEL Powder to 10 minutes after application | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bleeding, broad area oozing bleeding, hemostat, topical hemostatic agents, adjunctive hemostats