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

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

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.

Study Overview

• Status: Completed
• Conditions: Hemorrhage
• Intervention / Treatment: Device: SURGICEL Powder

Detailed Description

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
• Enrollment (Actual): 103
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Genk, Belgium, 3600
    • Ziekenhuis Oost Limburg
  • Gent, Belgium, 9000
    • Universitair Ziekenhuis Gent
• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Cambridge University Hospitals NHS Trust (Addenbrooke's Hospital)
  • Clydebank, United Kingdom, G81 4DY, GB
    • Golden Jubilee National Hospital
  • Leeds, United Kingdom, LS9 7TF
    • Leeds Teaching Hospitals NHS Trust (St James's University Hospital)
  • Newcastle upon Tyne, United Kingdom, NE7 7DN
    • Newcastle upon Tyne NHS Foundation Trust (Freeman Hospital)
  • Nottingham, United Kingdom, NG7 2UH
    • Nottingham University Hospitals NHS Trust
  • Lothian
    • Edinburgh, Lothian, United Kingdom, EH4 2XU
      • NHS Lothian (Western General Hospital)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Ethicon, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2018
• Primary Completion (Actual): December 2, 2019
• Study Completion (Actual): June 3, 2020

Study Registration Dates

• First Submitted: November 26, 2018
• First Submitted That Met QC Criteria: November 30, 2018
• First Posted (Actual): December 3, 2018

Study Record Updates

• Last Update Posted (Actual): July 26, 2021
• Last Update Submitted That Met QC Criteria: July 23, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: bleeding; broad area oozing bleeding; hemostat; topical hemostatic agents; adjunctive hemostats
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: BIOS-2017-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes