Back to resultsThe SURGICEL® Powder Mild or Moderate Parenchymal or Soft Tissue Intraoperative Bleeding (China Study)
Primary Purpose
Hemorrhage
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
SURGICEL Powder
SURGICEL Original
Sponsored by
About this trial
This is an interventional treatment trial for Hemorrhage focused on measuring bleeding, broad area oozing bleeding, hemostat, topical hemostatic agents, adjunctive hemostats
Eligibility Criteria
Inclusion Criteria:
- Adult subjects aged ≥18 years requiring elective/non-emergent open or laparoscopic general, gynecological, or cardiothoracic surgical procedures.
- Subject or authorized representative has signed the approved Informed Consent.
- Subject(s) whose platelet count is ≥100,000 per microliter and International Normalized Ratio (INR) is <1.5 prior to 24 hours of surgery.
- 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.
Exclusion Criteria:
- Female subjects who are pregnant or nursing.
- Subject on heparin within 12 hours prior to surgery, or oral Coumadin (warfarin) and/or Factor Xa inhibitors within 3 days prior to surgery.
- Subject on antiplatelet/P2Y12 inhibitors medication 5 days prior to surgery;
- Subject is currently participating or plans to participate in any other investigational product or drug trial 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.
- 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 1).
- 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
Sites / Locations
- Zhejiang Provincial People's Hospital
- Jiangsu Province Hospital
- Nanjing Drum Tower Hospital - Nanjing University Medical School
- Ruijin Hospital - Shanghai Jiaotong University School of Medicine
- Shanghai Xinhua Hospital
- The Affiliated Hospital of Xuzhou Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SURGICEL Powder
SURGICEL Original
Arm Description
SURGICEL Powder is an absorbable hemostat that is oxidized regenerated cellulose in a powder form
SURGICEL Original is an bsorbable hemostat that is oxidized regenerated cellulose in a fabric form
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03783039
Brief Title
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
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
December 3, 2019 (Actual)
Study Completion Date
May 6, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ethicon, LLC
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhage
Keywords
bleeding, broad area oozing bleeding, hemostat, topical hemostatic agents, adjunctive hemostats
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
234 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SURGICEL Powder
Arm Type
Experimental
Arm Description
SURGICEL Powder is an absorbable hemostat that is oxidized regenerated cellulose in a powder form
Arm Title
SURGICEL Original
Arm Type
Active Comparator
Arm Description
SURGICEL Original is an bsorbable hemostat that is oxidized regenerated cellulose in a fabric form
Intervention Type
Device
Intervention Name(s)
SURGICEL Powder
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
SURGICEL Original
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hemostatic Success at 5 Minutes
Description
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
Time Frame
From product application to 5 minutes following product application
Secondary Outcome Measure Information:
Title
Hemostatic Success at 3 Minutes
Description
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
Time Frame
From product application to 3 minutes following product application
Title
Hemostatic Success at 10 Minutes
Description
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
Time Frame
From product application to 10 minutes following product application
Other Pre-specified Outcome Measures:
Title
Number of Participants With Thromboembolic Events
Description
Number of participants with thrombotic events assessed as unlikely, possibly, probably or related to the study treatment
Time Frame
From enrollment to 30-day follow-up visit
Title
Number of Participants With Post-operative Re-bleeding Events
Description
Number of participants with post-operative re-bleeding events assessed as unlikely, possibly, probably or related to study treatment and requiring medical/surgical intervention
Time Frame
From initiation of final fascial closure to 30-day follow-up visit
Title
Number of Participants With Serious Adverse Events Requiring Surgical Intervention
Description
Number of Participants with Serious Adverse Events requiring surgical intervention and assessed as being unlikely, possibly, probably or related to study treatment
Time Frame
From enrollment to 6 month follow up visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult subjects aged ≥18 years requiring elective/non-emergent open or laparoscopic general, gynecological, or cardiothoracic surgical procedures.
Subject or authorized representative has signed the approved Informed Consent.
Subject(s) whose platelet count is ≥100,000 per microliter and International Normalized Ratio (INR) is <1.5 prior to 24 hours of surgery.
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.
Exclusion Criteria:
Female subjects who are pregnant or nursing.
Subject on heparin within 12 hours prior to surgery, or oral Coumadin (warfarin) and/or Factor Xa inhibitors within 3 days prior to surgery.
Subject on antiplatelet/P2Y12 inhibitors medication 5 days prior to surgery;
Subject is currently participating or plans to participate in any other investigational product or drug trial 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.
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 1).
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
Facility Information:
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
Country
China
Facility Name
Nanjing Drum Tower Hospital - Nanjing University Medical School
City
Nanjing
Country
China
Facility Name
Ruijin Hospital - Shanghai Jiaotong University School of Medicine
City
Shanghai
Country
China
Facility Name
Shanghai Xinhua Hospital
City
Shanghai
Country
China
Facility Name
The Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
Country
China
12. IPD Sharing Statement
Learn more about this trial
The SURGICEL® Powder Mild or Moderate Parenchymal or Soft Tissue Intraoperative Bleeding (China Study)
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