Surgicel Snow in Gynecological Surgery

NCT ID: NCT02908841

Last Updated: 2021-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2019-02-11

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.

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

Conditions

Laparoscopic Hysterectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Standard of Care

Intervention Type: 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.

Group Type: OTHER

Surgicel Snow

Intervention Type: DEVICE

Interventions

Surgicel Snow

Intervention Type: DEVICE

Standard of Care

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ethicon, Inc.

INDUSTRY

Sponsor Role: collaborator

Danbury Hospital

OTHER

Sponsor Role: lead

Responsible Party

Joann Petrini, PhD, MPH

Director, Clinical Outcomes and Health Services Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joann Petrini, PhD

Role: STUDY_CHAIR

Nuvance Health

Locations

Danbury Hospital

Danbury, Connecticut, United States

Physicians for Women's Health

Norwalk, Connecticut, United States

Norwalk Hospital

Norwalk, Connecticut, United States

Countries

United States

References

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

16-02-37-337

Identifier Type: -

Identifier Source: org_study_id