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Surgicel Snow in Gynecological Surgery

Sponsor
Danbury Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02908841
Collaborator
Ethicon, Inc. (Industry)
43
Enrollment
3
Locations
2
Arms
31.4
Actual Duration (Months)
14.3
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Surgicel Snow is an FDA approved topical hemostatic agent for use during surgical procedures. Like the other mechanical agents, Surgicel Snow forms a physical barrier that blocks blood flow while providing a large surface area for the rapid formation of a fibrin clot. As a mechanical agent derived from oxidized regenerated cellulose, Surgicel Snow shares with other mechanical hemostatic agents, the benefits of a favorable risk profile. This study would examine the efficacy of Surgicel Snow vs. direct compression in the control of capillary, venous, and small arterial hemorrhage when ligation or other conventional methods of control are impractical or ineffective in patients undergoing laparoscopic or robotic assisted laparoscopic hysterectomy. The intraoperative inclusion bleeding characteristics are minimal and mild retroperitoneal bleeding and moderate retroperitoneal bleeding that has been adequately reduced by standard surgical methods. 60 patients will be recruited for this study, all of which will be scheduled for hysterectomy at Western Connecticut Health Network (Norwalk Hospital and Danbury Hospital) under the direction of Dr. Thomas Rutherford, Dr. John Garofalo, and Dr. Robert Samuelson. The investigators will randomize 30 patients to the treatment group and 30 patients to the control group. Participants may continue all regular medications before and during the study. The consent process will be incorporated into the last pre-operative office visit. The health risks associated with use of Surgicel Snow may be less, the same or more than direct pressure alone. Surgicel Snow is generally used for minimal to mild bleeding from specific or widespread area; however, its effectiveness compared to direct pressure is unknown for a hysterectomy surgery.

Condition or Disease Intervention/Treatment Phase
  • Device: Surgicel Snow
  • Other: Standard of Care
 N/A

Detailed Description

Topical hemostatic agents have been introduced as adjunct therapies to standard surgical techniques in the management of intraoperative bleeding. They are particularly useful in widespread non-anatomic bleeding or bleeding involving sensitive tissues. Topical hemostatic agents can be classified into four broad categories based on function: mechanical agents, biologic agents, flowable sealants, and fibrin sealants. Mechanical agents derived from oxidized regenerated cellulose forms a physical barrier to block blood flow, while providing a large surface area for rapid fibrin clot formation. The benefit of this mechanical agent includes a favorable risk profile. They are inexpensive, rapidly absorbed, rarely induces a local inflammatory response or fibrosis, and no reported potential for inducing immunological response or anaphylaxis.

In current literature, oxidized regenerated cellulose has been shown to reduce the length of stay and resource utilization in cardiovascular and neurologic procedures. Although these agents are being used with increasing frequency, there is a paucity of evidence to support a similar benefit in gynecologic surgery with the exception of a small number of studies on myomectomy and ovarian surgery. Although it is known that all of the agents presently approved by the FDA are capable of shortening the bleeding time associated with surgical incisions, there are limited studies to show comparative efficacy or clinical impact with respect to estimated blood loss in the retroperitoneal space. The results of extensive bleeding in the retroperitoneal spaces include significant blood loss with dissection along the extraperitoneal fascial planes, as well as intraperitoneal collection, hematoma, and abscess. Patients with postoperative pelvic collections may present with symptoms of fever, rectal pain, or lower abdominal pain. Treatment often requires IR (interventional radiology) drainage and readmission for inpatient parenteral antibiotic therapy. The initial approach to hemostasis in the pelvis depends on the nature of bleeding encountered. When bleeding is encountered during pelvic dissection, evaluation of the extent and sources of bleeding, as well as its anatomic location and proximity to vital structures are the first requirements. The process of evaluating bleeding requires inspection of the bleeding sites augmented by irrigation, suctioning, and blotting with gauze. Through this process, the rate (minimal, mild, moderate, and severe) , distribution (local vs. diffuse), anatomic site (i.e., if in close proximity to vital structures), and source of blood loss (small arterial, venous or capillary) is ascertained.

In this study, investigators would examine the efficacy of Surgicel Snow, a topical mechanical hemostatic agent, versus direct compression in the control of capillary, venous, and small arterial hemorrhage when ligation or other conventional methods of control are impractical or ineffective in patients undergoing laparoscopic or robotic assisted laparoscopic hysterectomy.

Primary Outcomes:

  • Time to hemostasis

  • Failure to achieve hemostasis

Secondary Outcomes:

  • Total intraoperative time

  • Intraoperative blood loss

Study Design

Study Type:
Interventional
Actual Enrollment :
43 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Surgicel Snow in Gynecological Surgery
Actual Study Start Date :
Jul 1, 2016
Actual Primary Completion Date :
Sep 1, 2018
Actual Study Completion Date :
Feb 11, 2019

Arms and Interventions

Arm Intervention/Treatment
Other: Control

30 patients randomized to the control group and will receive standard of care. Control patients will be managed with direct compression with gauze pads or laparotomy pads for four minutes. If hemostasis is not achieved by compression after four minutes, the source and rate of bleeding will be reevaluated and management will be determined by the surgeon. If the surgeon uses SurgicelSnow to achieve hemostasis at some point after 4 minutes, the patient will be included in the control group, but the data will be and flagged for the analysis. If failure of hemostasis at 4 minutes with an estimated loss of ≥25 cc/min, patient will be managed as per judgment of surgeon. Persistent bleeding at the 10 minute observation point will be treated as per the surgeon's judgment.

Other: Standard of Care
Other: Treatment

30 patients randomized to the treatment group will receive 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 will be applied over the area of bleeding and positioned firmly in direct contact to the areas of bleeding with blunt surgical instruments. Surgicel Snow will be left in the cavity to be absorbed. Dry gauze will not be placed over the material. No adjuncts will be added to the enhance hemostasis, but patients with small arteriolar bleeding will have pressure maintained on the bleeding site for 60 seconds. Hemostatic failure at 4 minutes will be reassessed for rate of blood loss and if the rate of loss is estimated at less than 25 cc per minute, additional observations will be made at 7 and 10 minutes.

Device: Surgicel Snow

Outcome Measures

Primary Outcome Measures

  1. Change in Bleeding at Specified Time Intervals [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.

Secondary Outcome Measures

  1. Total Intraoperative Time [up to 4 hours]

    Total intraoperative was collected from medical record.

  2. Rate of Intraoperative Blood Loss [up to 4 hours]

    Intraoperative blood loss data was collected from medical record.

  3. Blood Transfusion [up to 4 hours]

    Blood transfusion details was collected from medical record.

  4. Total Postoperative Symptomatic Fluid Collection [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.

  5. Number of Participants With Postoperative Pelvic Abscess [through study completion, an average of 6 weeks]

    Postoperative pelvic abscess data was collected from medical record.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion criteria:

  1. Women ≥18 years of age

  2. Women scheduled for standard multiport laparoscopic, single site laparoscopic, and robotic assisted laparoscopic hysterectomy.

  3. Sites of surgery include Norwalk Hospital and Danbury Hospital.

  4. Indication for surgery includes benign, complex benign, and malignant conditions.

  5. Signed informed consent

Exclusion criteria:

  1. Vaginal hysterectomy or open abdominal hysterectomy;

  2. Congenital or acquired coagulation disorder including recent (within 7 days of surgery) therapeutic anticoagulation or use agents affecting platelet function, other than low dose aspirin. (Preoperative prophylactic heparin is not an exclusion criterion.)

  3. Hysterectomy at the time of sacrocolpopexy.

  4. Ovarian cancer

Contacts and Locations

Locations

Site City State Country Postal Code
1 Danbury Hospital Danbury Connecticut United States 06810
2 Physicians for Women's Health Norwalk Connecticut United States 06850
3 Norwalk Hospital Norwalk Connecticut United States 06856

Sponsors and Collaborators

  • Danbury Hospital
  • Ethicon, Inc.

Investigators

  • Study Chair: Joann Petrini, PhD, Nuvance Health

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Joann Petrini, PhD, MPH, Director, Clinical Outcomes and Health Services Research, Danbury Hospital
ClinicalTrials.gov Identifier:
NCT02908841
Other Study ID Numbers:
  • 16-02-37-337
First Posted:
Sep 21, 2016
Last Update Posted:
Jul 14, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No

Study Results

Participant Flow

Recruitment Details 43 patients were enrolled in the study, 21 patients were excluded due to lack of intraoperative bleeding.
Pre-assignment Detail
Arm/Group Title Control Treatment
Arm/Group Description 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 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
Period Title: Overall Study
STARTED 10 12
COMPLETED 6 12
NOT COMPLETED 4 0

Baseline Characteristics

Arm/Group Title Control Treatment Total
Arm/Group Description Standard of Care Surgicel Snow Total of all reporting groups
Overall Participants 6 12 18
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
51.5
(8.6)
45.4
(8.8)
50.3
(10.9)
Sex/Gender, Customized (Count of Participants)
Female
6
100%
12
100%
18
100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
Asian
0
0%
0
0%
0
0%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
Black or African American
0
0%
2
16.7%
2
11.1%
White
4
66.7%
6
50%
10
55.6%
More than one race
0
0%
0
0%
0
0%
Unknown or Not Reported
2
33.3%
4
33.3%
6
33.3%
BMI (kilograms/metres2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilograms/metres2]
33.9
(10.3)
28.8
(4.1)
30.5
(7.0)

Outcome Measures

1. Primary Outcome
Title Change in Bleeding at Specified Time Intervals
Description 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.
Time Frame 4 minutes, 7 minutes and 10 minutes

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Control Treatment
Arm/Group Description Standard of Care Surgicel Snow
Measure Participants 6 12
Mean (Standard Deviation) [seconds]
485.7
(432.3)
199.1
(72.8)
2. Secondary Outcome
Title Total Intraoperative Time
Description Total intraoperative was collected from medical record.
Time Frame up to 4 hours

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Control Treatment
Arm/Group Description Standard of Care Surgicel Snow
Measure Participants 6 12
Mean (Standard Deviation) [minutes]
166.2
(37.4)
236.2
(54.0)
3. Secondary Outcome
Title Rate of Intraoperative Blood Loss
Description Intraoperative blood loss data was collected from medical record.
Time Frame up to 4 hours

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Control Treatment
Arm/Group Description Standard of Care Surgicel Snow
Measure Participants 6 12
Mean (Standard Deviation) [cubic centimeter/minute]
82.5
(50.4)
214.1
(126.4)
4. Secondary Outcome
Title Blood Transfusion
Description Blood transfusion details was collected from medical record.
Time Frame up to 4 hours

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Control Treatment
Arm/Group Description Standard of Care Surgicel Snow
Measure Participants 6 12
Mean (Standard Deviation) [cubic centimetre]
NA
(NA)
172.2
(402.4)
5. Secondary Outcome
Title Total Postoperative Symptomatic Fluid Collection
Description 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.
Time Frame through study completion, an average of 6 weeks

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Control Treatment
Arm/Group Description Standard of Care Surgicel Snow
Measure Participants 6 12
Mean (Standard Deviation) [cc/weeks]
NA
(NA)
NA
(NA)
6. Secondary Outcome
Title Number of Participants With Postoperative Pelvic Abscess
Description Postoperative pelvic abscess data was collected from medical record.
Time Frame through study completion, an average of 6 weeks

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Control Treatment
Arm/Group Description Standard of Care Surgicel Snow
Measure Participants 6 12
Count of Participants [Participants]
0
0%
0
0%

Adverse Events

Time Frame Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up to 6 weeks
Adverse Event Reporting Description
Arm/Group Title Control Treatment
Arm/Group Description Subjects randomized to the control group and received standard of care. Subjects randomized to the treatment group received Surgicel Snow.
All Cause Mortality
Control Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/10 (0%) 0/12 (0%)
Serious Adverse Events
Control Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 1/10 (10%) 0/12 (0%)
Injury, poisoning and procedural complications
Bowel perforation 1/10 (10%) 1 0/12 (0%) 0
Other (Not Including Serious) Adverse Events
Control Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/10 (0%) 0/12 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Joann Petrini
Organization Western Connecticut Health Network
Phone 203-739-6882
Email Joann.Petrini@wchn.org
Responsible Party:
Joann Petrini, PhD, MPH, Director, Clinical Outcomes and Health Services Research, Danbury Hospital
ClinicalTrials.gov Identifier:
NCT02908841
Other Study ID Numbers:
  • 16-02-37-337
First Posted:
Sep 21, 2016
Last Update Posted:
Jul 14, 2021
Last Verified:
Jul 1, 2021