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

NCT03762200 | Completed Results FDA Device

• 1 other identifier: BIOS-2017-01
• Study Type: interventional
• Target: 103
• Locations: 2 countries
• Sites: 8

Brief Summary

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.

Conditions

Hemorrhage

Keywords

bleeding; broad area oozing bleeding; hemostat; topical hemostatic agents; adjunctive hemostats

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Haemostatic Success at 3 Minutes

  From application of SURGICEL Powder to 3 minutes after application

• Haemostatic Success at 10 Minutes

  From application of SURGICEL Powder to 10 minutes after application

Other Outcomes (3)

• Number of Participants Experiencing a Thromboembolic Event

  From application of SURGICEL Powder to 30 day follow-up visit

• Number of Participants With Post-operative Re-bleeding

  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

  From time of SURGICEL Powder application to 6-month follow up visit

Study Arms (1)

SURGICEL Powder - Single arm

OTHER

Single arm clinical trial where all qualified subjects will be treated SURGICEL Powder

Device: SURGICEL Powder

Interventions

SURGICEL Powder DEVICE

SURGICEL Powder is a topical absorbable hemostatic treatment made of oxidized regenerated cellulose (ORC) - plant material

SURGICEL Powder - Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Ethicon, Inc.: lead

Study Sites (8)

Ziekenhuis Oost Limburg

Genk, 3600, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

NHS Lothian (Western General Hospital)

Edinburgh, Lothian, EH4 2XU, United Kingdom

Location

Cambridge University Hospitals NHS Trust (Addenbrooke's Hospital)

Cambridge, CB2 0QQ, United Kingdom

Location

Golden Jubilee National Hospital

Clydebank, G81 4DY, GB, United Kingdom

Location

Leeds Teaching Hospitals NHS Trust (St James's University Hospital)

Leeds, LS9 7TF, United Kingdom

Location

Newcastle upon Tyne NHS Foundation Trust (Freeman Hospital)

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, NG7 2UH, United Kingdom

Location

Related Publications (1)

• Al-Attar N, de Jonge E, Kocharian R, Ilie B, Barnett E, Berrevoet F. Safety and Hemostatic Effectiveness of SURGICEL(R) Powder in Mild and Moderate Intraoperative Bleeding. Clin Appl Thromb Hemost. 2023 Jan-Dec;29:10760296231190376. doi: 10.1177/10760296231190376.

  PMID: 37501509 DERIVED

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Patricia Schleckser
• Organization: ETHICON, Inc

PSchleck@its.jnj.com

01 908 218 2244

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: December 3, 2018
• Study Start: November 26, 2018
• Primary Completion: December 2, 2019
• Study Completion: June 3, 2020
• Last Updated: July 26, 2021
• Results First Posted: December 22, 2020

Record last verified: 2021-07

Locations

GB (6); BE (2)