N/A
N=22
Surgicel Snow in Gynecological Surgery
Laparoscopic Hysterectomy
Bottom Line
View on ClinicalTrials.gov: NCT02908841 ↗Enrolled (actual)
22
Serious AEs
4.6%
Results posted
Dec 2020
Primary outcome: Primary: Change in Bleeding at Specified Time Intervals — 485.7; 199.1 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Surgicel Snow (Device); Standard of Care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Danbury Hospital
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Bleeding at Specified Time Intervals |
485.7; 199.1 | — |
| SECONDARY Total Intraoperative Time |
166.2; 236.2 | — |
| SECONDARY Rate of Intraoperative Blood Loss |
82.5; 214.1 | — |
| SECONDARY Blood Transfusion |
NA; 172.2 | — |
| SECONDARY Total Postoperative Symptomatic Fluid Collection |
NA; NA | — |
| SECONDARY Number of Participants With Postoperative Pelvic Abscess |
0; 0 | — |
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.
Eligibility Criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02908841). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.