Hemorrhage Clinical Trial
Official title:
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
Verified date | July 2021 |
Source | Ethicon, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 103 |
Est. completion date | June 3, 2020 |
Est. primary completion date | December 2, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Pre-operative: 1. Adult subjects = 18 years requiring elective/non-emergent open or laparoscopic general, gynaecological, cardiothoracic, or urological surgical procedures; 2. Subject or authorised representative has signed the approved Informed Consent; 3. Subject(s) whose International Normalised Ratio is <1.5 within 24 hours of surgery. Intra-operative: 4. Presence of an appropriate TBS identified intra-operatively by the surgeon; 5. Subject(s) undergoing cardiothoracic surgery with anticoagulation must have anticoagulation reversed prior to TBS identification and treatment. Exclusion Criteria: Pre-operative: 1. Female subjects who are pregnant or nursing; 2. 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; 3. 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. 4. Subject is currently participating or plans to participate in any other investigational device or drug without prior approval from the Sponsor; 5. Subjects who are known, current alcohol and/or drug abusers; 6. Subjects with any pre-operative findings identified by the surgeon that may preclude conduct of the study procedure. Intra-operative: 7. Subjects with any intra-operative findings identified by the surgeon that may preclude the use of study product; 8. 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)]; 9. 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; 10. Major arterial or venous bleeding or major defects in arteries and veins; 11. TBS where silver nitrate or any other escharotic chemicals have been applied; 12. TBS is in, around, or in proximity to foramina in bone, or areas of bony confine, the spinal cord, or optic nerve and chiasm; 13. TBS in urological procedures where plugging (blocking) of the urethra, ureter or a catheter is possible by the study product. |
Country | Name | City | State |
---|---|---|---|
Belgium | Ziekenhuis Oost Limburg | Genk | |
Belgium | Universitair Ziekenhuis Gent | Gent | |
United Kingdom | Cambridge University Hospitals NHS Trust (Addenbrooke's Hospital) | Cambridge | |
United Kingdom | Golden Jubilee National Hospital | Clydebank | |
United Kingdom | NHS Lothian (Western General Hospital) | Edinburgh | Lothian |
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 |
Lead Sponsor | Collaborator |
---|---|
Ethicon, Inc. |
Belgium, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of Participants Experiencing a Thromboembolic Event | Number of participants experiencing a thromboembolic event that was assessed as having either an unlikely, possible, probable or causal relationship to the study treatment | From application of SURGICEL Powder to 30 day follow-up visit | |
Other | Number of Participants With Post-operative Re-bleeding | Number of participants of post-operative re-bleeding that was assessed as having either an unlikely, possible, probable or causal relationship to the TBS and requiring medical/surgical intervention | From initiation of final fascial closure to the 30-day follow up visit | |
Other | Number of Participants Experiencing a Serious Adverse Events Requiring Surgical Intervention and Related to SURGICEL Powder | Number of participants experiencing a serious adverse event requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment | From time of SURGICEL Powder application to 6-month follow up visit | |
Primary | 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 | 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 | |
Secondary | 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 |
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