Hemorrhage
Conditions
Keywords
bleeding, broad area oozing bleeding, hemostat, topical hemostatic agents, adjunctive hemostats
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.
Interventions
DEVICESURGICEL 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.
DEVICESURGICEL 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.
Sponsors
Ethicon, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemostatic Success at 5 Minutes | From product application to 5 minutes following product application | 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
| Measure | Time frame | Description |
|---|---|---|
| Hemostatic Success at 3 Minutes | From product application to 3 minutes following product application | 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 | From product application to 10 minutes following product application | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Thromboembolic Events | From enrollment to 30-day follow-up visit | Number of participants with thrombotic events assessed as unlikely, possibly, probably or related to the study treatment |
| Number of Participants With Post-operative Re-bleeding Events | From initiation of final fascial closure to 30-day follow-up visit | Number of participants with post-operative re-bleeding events assessed as unlikely, possibly, probably or related to study treatment and requiring medical/surgical intervention |
| Number of Participants With Serious Adverse Events Requiring Surgical Intervention | From enrollment to 6 month follow up visit | Number of Participants with Serious Adverse Events requiring surgical intervention and assessed as being unlikely, possibly, probably or related to study treatment |
Countries
China
Participant flow
Recruitment details
Subjects were screened up to 21 days prior to surgery and attended a baseline visit within 24 hours of surgery. Both visits took place at a clinic within the hospital where surgery also took place. Subjects were followed until hospital discharge and requested to attend a visit at 30 (+14) days post surgery and at 6 months (+/- 30 days) either at the hospital or via telephone.
Pre-assignment details
Subjects required to meet pre-defined inclusion/exclusion criteria prior to receiving study product. Subjects required to have an appropriate mild or moderate target bleeding site (TBS) identified intra-operatively. Subjects excluded if the TBS was where silver nitrate or any other escharotic chemicals were applied, was in, around, or in proximity to foramina in bone, areas of bony confine.
Participants by arm
| Arm | Count |
|---|---|
| SURGICEL Powder SURGICEL Powder Absorbable Hemostat (Oxidized Regenerated Cellulose) | 119 |
| SURGICEL Original Absorbable Hemostat (Oxidized Regenerated Cellulose) | 115 |
| Total | 234 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 1 |
Baseline characteristics
| Characteristic | SURGICEL Original | Total | SURGICEL Powder |
|---|---|---|---|
| Age, Continuous | 52.0 Years | 53.0 Years | 54.0 Years |
| Race/Ethnicity, Customized Han | 114 Participants | 230 Participants | 116 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 4 Participants | 3 Participants |
| Sex: Female, Male Female | 73 Participants | 150 Participants | 77 Participants |
| Sex: Female, Male Male | 42 Participants | 84 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 119 | 1 / 115 |
| other Total, other adverse events | 83 / 119 | 80 / 115 |
| serious Total, serious adverse events | 9 / 119 | 5 / 115 |
Outcome results
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
Time frame: From product application to 5 minutes following product application
Population: Per Protocol Analysis (All intent to treat subjects who have no major protocol deviations and have data available for primary effectiveness endpoint)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SURGICEL Powder | Hemostatic Success at 5 Minutes | 109 Participants |
| SURGICEL Original | Hemostatic Success at 5 Minutes | 103 Participants |
p-value: <0.0001Farrington-Manning method
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
Time frame: From product application to 10 minutes following product application
Population: Intent to Treat Analysis (All randomized and enrolled subjects for whom TBS was identified. Subjects who did not complete the procedure after TBS identification were included in the ITT)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SURGICEL Powder | Hemostatic Success at 10 Minutes | 114 Participants |
| SURGICEL Original | Hemostatic Success at 10 Minutes | 107 Participants |
95% CI: [-0.0312, 0.0863]Farrington-Manning Method
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
Time frame: From product application to 3 minutes following product application
Population: Intent to Treat Analysis (All randomized and enrolled subjects for whom TBS was identified. Subjects who did not complete the procedure after TBS identification were included in the ITT)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SURGICEL Powder | Hemostatic Success at 3 Minutes | 107 Participants |
| SURGICEL Original | Hemostatic Success at 3 Minutes | 92 Participants |
95% CI: [0.0078, 0.1906]Farrington-Manning Method
Other Pre-specified
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
Time frame: From initiation of final fascial closure to 30-day follow-up visit
Population: Safety Analysis Set (All enrolled subjects who underwent study procedure and received study product, and had post-baseline data. Enrollment defined as subjects with completed informed consent and meets all inclusion criteria and does not meet any exclusion criteria)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SURGICEL Powder | Number of Participants With Post-operative Re-bleeding Events | Investigator Assessment | 1 Participants |
| SURGICEL Powder | Number of Participants With Post-operative Re-bleeding Events | Sponsor Assessment | 1 Participants |
| SURGICEL Original | Number of Participants With Post-operative Re-bleeding Events | Investigator Assessment | 1 Participants |
| SURGICEL Original | Number of Participants With Post-operative Re-bleeding Events | Sponsor Assessment | 0 Participants |
Other Pre-specified
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
Time frame: From enrollment to 6 month follow up visit
Population: Safety Analysis Set (All enrolled subjects who underwent study procedure and received study product, and had post-baseline data. Enrollment defined as subjects with completed informed consent and meets all inclusion criteria and does not meet any exclusion criteria)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SURGICEL Powder | Number of Participants With Serious Adverse Events Requiring Surgical Intervention | 0 Participants |
| SURGICEL Original | Number of Participants With Serious Adverse Events Requiring Surgical Intervention | 0 Participants |
Other Pre-specified
Number of Participants With Thromboembolic Events
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
Population: Safety Analysis Set (All enrolled subjects who underwent study procedure and received study product, and had post-baseline data. Enrollment defined as subjects with completed informed consent and meets all inclusion criteria and does not meet any exclusion criteria)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SURGICEL Powder | Number of Participants With Thromboembolic Events | Investigator Assessment | 0 Participants |
| SURGICEL Powder | Number of Participants With Thromboembolic Events | Sponsor Assessment | 0 Participants |
| SURGICEL Original | Number of Participants With Thromboembolic Events | Investigator Assessment | 0 Participants |
| SURGICEL Original | Number of Participants With Thromboembolic Events | Sponsor Assessment | 0 Participants |