Trial Outcomes & Findings for Surgicel Snow in Gynecological Surgery (NCT NCT02908841)

NCT ID: NCT02908841

Last Updated: 2021-07-14

Results Overview

Because multiple factors other than retroperitoneal bleeding contribute to the total intraoperative bleed loss, the investigators believe that the intraoperative estimated blood loss is not a pure indicator of the efficacy of a topical hemostatic agent for control of retroperitoneal bleeding. Data from the specified time points (4 minutes, 7 minutes and 10 minutes) was combined to calculate an average bleeding event time for each subject.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 43 participants
• Primary outcome timeframe: 4 minutes, 7 minutes and 10 minutes
• Results posted on: 2021-07-14

Participant Flow

43 patients were enrolled in the study, 21 patients were excluded due to lack of intraoperative bleeding.

Participant milestones

Measure	Control 10 patients randomized to the control group and received standard of care. Control patients were managed with direct compression with gauze pads or laparotomy pads for four minutes. If hemostasis was not achieved by compression after four minutes, the source and rate of bleeding were reevaluated and management was determined by the surgeon. If the surgeon used SurgicelSnow to achieve hemostasis at some point after 4 minutes, the patient was included in the control group, but the data was flagged for the analysis. If failure of hemostasis at 4 minutes with an estimated loss of ≥25 cc/min, patient was managed as per judgment of surgeon. Persistent bleeding at the 10 minute observation point was treated as per the surgeon's judgment. Standard of Care	Treatment 12 patients randomized to the treatment group received Surgicel Snow. For patients with qualifying bleeding (rated on initial evaluation as at least "mild") who have been randomized to receive Surgicel Snow, a single thin layer of dry Surgicel Snow was applied over the area of bleeding and positioned firmly in direct contact to the areas of bleeding with blunt surgical instruments. Surgicel Snow was left in the cavity to be absorbed. Dry gauze was not placed over the material. No adjuncts was added to the enhance hemostasis, but patients with small arteriolar bleeding, pressure was maintained on the bleeding site for 60 seconds. Hemostatic failure at 4 minutes was reassessed for rate of blood loss and if the rate of loss was estimated at less than 25 cc per minute, additional observations were made at 7 and 10 minutes. Surgicel Snow
Overall Study STARTED	10	12
Overall Study COMPLETED	6	12
Overall Study NOT COMPLETED	4	0

Reasons for withdrawal

Measure	Control 10 patients randomized to the control group and received standard of care. Control patients were managed with direct compression with gauze pads or laparotomy pads for four minutes. If hemostasis was not achieved by compression after four minutes, the source and rate of bleeding were reevaluated and management was determined by the surgeon. If the surgeon used SurgicelSnow to achieve hemostasis at some point after 4 minutes, the patient was included in the control group, but the data was flagged for the analysis. If failure of hemostasis at 4 minutes with an estimated loss of ≥25 cc/min, patient was managed as per judgment of surgeon. Persistent bleeding at the 10 minute observation point was treated as per the surgeon's judgment. Standard of Care	Treatment 12 patients randomized to the treatment group received Surgicel Snow. For patients with qualifying bleeding (rated on initial evaluation as at least "mild") who have been randomized to receive Surgicel Snow, a single thin layer of dry Surgicel Snow was applied over the area of bleeding and positioned firmly in direct contact to the areas of bleeding with blunt surgical instruments. Surgicel Snow was left in the cavity to be absorbed. Dry gauze was not placed over the material. No adjuncts was added to the enhance hemostasis, but patients with small arteriolar bleeding, pressure was maintained on the bleeding site for 60 seconds. Hemostatic failure at 4 minutes was reassessed for rate of blood loss and if the rate of loss was estimated at less than 25 cc per minute, additional observations were made at 7 and 10 minutes. Surgicel Snow
Overall Study Physician Decision	4	0

Baseline Characteristics

Surgicel Snow in Gynecological Surgery

Baseline characteristics by cohort

Measure	Control n=6 Participants Standard of Care	Treatment n=12 Participants Surgicel Snow	Total n=18 Participants Total of all reporting groups
Age, Continuous	51.5 years STANDARD_DEVIATION 8.6 • n=5 Participants	45.4 years STANDARD_DEVIATION 8.8 • n=7 Participants	50.3 years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex/Gender, Customized Female	6 Participants n=5 Participants	12 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
BMI	33.9 kilograms/metres2 STANDARD_DEVIATION 10.3 • n=5 Participants	28.8 kilograms/metres2 STANDARD_DEVIATION 4.1 • n=7 Participants	30.5 kilograms/metres2 STANDARD_DEVIATION 7.0 • n=5 Participants

PRIMARY outcome

Timeframe: 4 minutes, 7 minutes and 10 minutes

Because multiple factors other than retroperitoneal bleeding contribute to the total intraoperative bleed loss, the investigators believe that the intraoperative estimated blood loss is not a pure indicator of the efficacy of a topical hemostatic agent for control of retroperitoneal bleeding. Data from the specified time points (4 minutes, 7 minutes and 10 minutes) was combined to calculate an average bleeding event time for each subject.

Outcome measures

Measure	Control n=6 Participants Standard of Care	Treatment n=12 Participants Surgicel Snow
Change in Bleeding at Specified Time Intervals	485.7 seconds Standard Deviation 432.3	199.1 seconds Standard Deviation 72.8

SECONDARY outcome

Timeframe: up to 4 hours

Total intraoperative was collected from medical record.

Outcome measures

Measure	Control n=6 Participants Standard of Care	Treatment n=12 Participants Surgicel Snow
Total Intraoperative Time	166.2 minutes Standard Deviation 37.4	236.2 minutes Standard Deviation 54.0

SECONDARY outcome

Timeframe: up to 4 hours

Intraoperative blood loss data was collected from medical record.

Outcome measures

Measure	Control n=6 Participants Standard of Care	Treatment n=12 Participants Surgicel Snow
Rate of Intraoperative Blood Loss	82.5 cubic centimeter/minute Standard Deviation 50.4	214.1 cubic centimeter/minute Standard Deviation 126.4

SECONDARY outcome

Timeframe: up to 4 hours

Blood transfusion details was collected from medical record.

Outcome measures

Measure	Control n=6 Participants Standard of Care	Treatment n=12 Participants Surgicel Snow
Blood Transfusion	NA cubic centimetre Standard Deviation NA no participants in the Control Arm/Group had transfusions	172.2 cubic centimetre Standard Deviation 402.4

SECONDARY outcome

Timeframe: through study completion, an average of 6 weeks

Postoperative symptomatic fluid collection data collected at 2 week and 6 week time period was obtained from medical record. Data from 2 week and 6 week time points was combined to calculate the total postoperative symptomatic fluid collection for each subject.

Outcome measures

Measure	Control n=6 Participants Standard of Care	Treatment n=12 Participants Surgicel Snow
Total Postoperative Symptomatic Fluid Collection	NA cc/weeks Standard Deviation NA no participants in the Control Arm/Group had postoperative symptomatic fluid discharge	NA cc/weeks Standard Deviation NA no participants in the Treatment Arm/Group had postoperative symptomatic fluid discharge

SECONDARY outcome

Timeframe: through study completion, an average of 6 weeks

Postoperative pelvic abscess data was collected from medical record.

Outcome measures

Measure	Control n=6 Participants Standard of Care	Treatment n=12 Participants Surgicel Snow
Number of Participants With Postoperative Pelvic Abscess	0 Participants	0 Participants

Adverse Events

Control

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Control n=10 participants at risk Subjects randomized to the control group and received standard of care.	Treatment n=12 participants at risk Subjects randomized to the treatment group received Surgicel Snow.
Injury, poisoning and procedural complications Bowel perforation	10.0% 1/10 • Number of events 1 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up to 6 weeks	0.00% 0/12 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up to 6 weeks

Other adverse events

Adverse event data not reported

Additional Information

Joann Petrini

Western Connecticut Health Network

Phone: 203-739-6882

Email: Joann.Petrini@wchn.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place