The SURGICEL® Powder Mild or Moderate Parenchymal or Soft Tissue Intraoperative Bleeding (China Study)

Hemorrhage Clinical Trial

Official title:

A Prospective, RCT Evaluating the Safety and Hemostatic Effectiveness of SURGICEL Powder in Controlling Mild or Moderate Parenchymal or Soft Tissue Intraoperative Bleeding During Surgery in Chinese Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03783039
• Other study ID #: BIOS_2017_02
• Status: Completed
• Phase: N/A
• Start date: January 15, 2019
• Est. completion date: May 6, 2020

Study information

• Verified date: June 2021
• Source: Ethicon, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a single blind, randomized, prospective study comparing SURGICEL Powder with SURGICEL Original (control arm) as an adjunct to achieve hemostasis in the control of capillary, venous, and small arterial hemorrhage when ligation or other conventional methods of control are impractical or ineffective during surgery (open, laparoscopic, or thoracoscopic) in Chinese adult subjects.

Description:

This is a single blind, randomized, prospective study comparing SURGICEL Powder with SURGICEL Original (control arm) as an adjunct to achieve hemostasis in the control of capillary, venous, and small arterial hemorrhage when ligation or other conventional methods of control are impractical or ineffective during surgery (open, laparoscopic, or thoracoscopic) in Chinese adult subjects.

After application of either SURGICEL Powder or SURGICEL Original, the target bleeding site (TBS) will be assessed for hemostasis (no detectable bleeding) at 3, 5, and 10 minutes from application and prior to initiation of final fascial closure on open surgery or port site closure in laparoscopic or thoracoscopic procedures.

All enrolled subjects will be observed post-operatively through discharge and followed up at 30 days (+14 days) and at 6 months (+/-30 days) post-surgery via phone call or office visit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: May 6, 2020
• Est. primary completion date: December 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adult subjects aged =18 years requiring elective/non-emergent open or laparoscopic general, gynecological, or cardiothoracic surgical procedures.

2. Subject or authorized representative has signed the approved Informed Consent.

3. Subject(s) whose platelet count is =100,000 per microliter and International Normalized Ratio (INR) is <1.5 prior to 24 hours of surgery.

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:

1. Female subjects who are pregnant or nursing.

2. Subject on heparin within 12 hours prior to surgery, or oral Coumadin (warfarin) and/or Factor Xa inhibitors within 3 days prior to surgery.

3. Subject on antiplatelet/P2Y12 inhibitors medication 5 days prior to surgery;

4. Subject is currently participating or plans to participate in any other investigational product or drug trial 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.

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 1).

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

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Hemorrhage

Intervention

Device:
• SURGICEL Powder
Surgeon to perform surgical procedure according to standard of care. If randomized to SURGICEL Powder, the product will be be applied to the first appropriate TBS with mild or moderate bleeding in parenchyma or soft tissue where conventional methods of control (i.e. suture, ligature, cautery) are ineffective or impractical.
• SURGICEL Original
Surgeon to perform surgical procedure according to standard of care. If randomized to SURGICEL Original, the product will be be applied to the first appropriate TBS with mild or moderate bleeding in parenchyma or soft tissue where conventional methods of control (i.e. suture, ligature, cautery) are ineffective or impractical.

Locations

Country	Name	City	State
China	Zhejiang Provincial People's Hospital	Hangzhou
China	Jiangsu Province Hospital	Nanjing
China	Nanjing Drum Tower Hospital - Nanjing University Medical School	Nanjing
China	Ruijin Hospital - Shanghai Jiaotong University School of Medicine	Shanghai
China	Shanghai Xinhua Hospital	Shanghai
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon, LLC

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Thromboembolic Events	Number of participants with thrombotic events assessed as unlikely, possibly, probably or related to the study treatment	From enrollment to 30-day follow-up visit
Other	Number of Participants With Post-operative Re-bleeding Events	Number of participants with post-operative re-bleeding events assessed as unlikely, possibly, probably or related to study treatment and requiring medical/surgical intervention	From initiation of final fascial closure to 30-day follow-up visit
Other	Number of Participants With Serious Adverse Events Requiring Surgical Intervention	Number of Participants with Serious Adverse Events requiring surgical intervention and assessed as being unlikely, possibly, probably or related to study treatment	From enrollment to 6 month follow up visit
Primary	Hemostatic Success at 5 Minutes	Percentage of subjects achieving hemostatic success at 5 minutes following study product application with no rebleeding requiring additional treatment at the Target Bleeding Site (TBS) any time prior to initiation of final fascial closure	From product application to 5 minutes following product application
Secondary	Hemostatic Success at 3 Minutes	Percentage of subjects achieving hemostatic success at 3 minutes following study product application with no rebleeding requiring additional treatment at the TBS any time prior to initiation of final fascial closure	From product application to 3 minutes following product application
Secondary	Hemostatic Success at 10 Minutes	Percentage of subjects achieving hemostatic success at 10 minutes following study product application with no rebleeding requiring additional treatment at the TBS any time prior to initiation of final fascial closure	From product application to 10 minutes following product application