Clinical trial NCT03783039: The SURGICEL® Powder Mild or Moderate Parenchymal or Soft Tissue Intraoperative Bleeding (China Study)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemorrhage
Keywords: bleeding
broad area oozing bleeding
hemostat
topical hemostatic agents
adjunctive hemostats
Lead sponsor: Ethicon, LLC
Sponsor class: INDUSTRY
First posted: 2018-12-20
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Hemostatic Success at 5 Minutes
timeFrame: From product application to 5 minutes following product application
Secondary outcomes:
measure: Hemostatic Success at 3 Minutes
timeFrame: From product application to 3 minutes following product application
measure: Hemostatic Success at 10 Minutes
timeFrame: From product application to 10 minutes following product application
Other outcomes:
measure: Number of Participants With Thromboembolic Events
timeFrame: From enrollment to 30-day follow-up visit
measure: Number of Participants With Post-operative Re-bleeding Events
timeFrame: From initiation of final fascial closure to 30-day follow-up visit
measure: Number of Participants With Serious Adverse Events Requiring Surgical Intervention
timeFrame: From enrollment to 6 month follow up visit
Locations:
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
city: Nanjing
country: China
facility: Jiangsu Province Hospital
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital - Nanjing University Medical School
city: Shanghai
country: China
facility: Ruijin Hospital - Shanghai Jiaotong University School of Medicine
city: Shanghai
country: China
facility: Shanghai Xinhua Hospital
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
Study officials:
References: