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

Ethicon

Status: Completed

Conditions: Hemorrhage

Treatments: Device: SURGICEL Original; Device: SURGICEL Powder

Study type: Interventional

Funder types: Industry

Identifiers

NCT03783039

BIOS_2017_02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 234 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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234 participants in 2 patient groups

SURGICEL Powder

Experimental group

Description:

SURGICEL Powder is an absorbable hemostat that is oxidized regenerated cellulose in a powder form

Treatment:

Device: SURGICEL Powder

SURGICEL Original

Active Comparator group

Description:

SURGICEL Original is an bsorbable hemostat that is oxidized regenerated cellulose in a fabric form

Treatment:

Device: SURGICEL Original