Surgicel Snow in Gynecological Surgery

Completed · Not applicable

Conditions studied: Laparoscopic Hysterectomy

In brief

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.

Key facts

Study ID

NCT02908841

Run by

Danbury Hospital

People needed

43

Starts

2016-07-01

Expected to finish

2019-02-11

Last updated by the study team

2021-07-14

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Women ≥18 years of age
• Women scheduled for standard multiport laparoscopic, single site laparoscopic, and robotic assisted laparoscopic hysterectomy.
• Sites of surgery include Norwalk Hospital and Danbury Hospital.
• Indication for surgery includes benign, complex benign, and malignant conditions.
• Signed informed consent

You may not qualify if…

• Vaginal hysterectomy or open abdominal hysterectomy;
• 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.)
• Hysterectomy at the time of sacrocolpopexy.
• Ovarian cancer

Where it is running

• Danbury Hospital — Danbury, Connecticut, United States
• Physicians for Women's Health — Norwalk, Connecticut, United States
• Norwalk Hospital — Norwalk, Connecticut, United States

Full record on ClinicalTrials.gov

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