Surgicel Snow in Gynecological Surgery

Laparoscopic Hysterectomy Clinical Trial

Official title:

Surgicel Snow in Gynecological Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02908841
• Other study ID #: 16-02-37-337
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: February 11, 2019

Study information

• Verified date: July 2021
• Source: Danbury Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: February 11, 2019
• Est. primary completion date: September 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Laparoscopic Hysterectomy

Intervention

Device:
• Surgicel Snow

Other:
• Standard of Care

Locations

Country	Name	City	State
United States	Danbury Hospital	Danbury	Connecticut
United States	Norwalk Hospital	Norwalk	Connecticut
United States	Physicians for Women's Health	Norwalk	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Danbury Hospital	Ethicon, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (11)

Angioli R, Muzii L, Montera R, Damiani P, Bellati F, Plotti F, Zullo MA, Oronzi I, Terranova C, Panici PB. Feasibility of the use of novel matrix hemostatic sealant (FloSeal) to achieve hemostasis during laparoscopic excision of endometrioma. J Minim Invasive Gynecol. 2009 Mar-Apr;16(2):153-6. doi: 10.1016/j.jmig.2008.11.007. Epub 2009 Jan 9. — View Citation

Angioli R, Plotti F, Ricciardi R, Terranova C, Zullo MA, Damiani P, Montera R, Guzzo F, Scaletta G, Muzii L. The use of novel hemostatic sealant (Tisseel) in laparoscopic myomectomy: a case-control study. Surg Endosc. 2012 Jul;26(7):2046-53. doi: 10.1007/s00464-012-2154-2. Epub 2012 Feb 1. — View Citation

Ata B, Turkgeldi E, Seyhan A, Urman B. Effect of hemostatic method on ovarian reserve following laparoscopic endometrioma excision; comparison of suture, hemostatic sealant, and bipolar dessication. A systematic review and meta-analysis. J Minim Invasive Gynecol. 2015 Mar-Apr;22(3):363-72. doi: 10.1016/j.jmig.2014.12.168. Epub 2015 Jan 5. Review. — View Citation

Martyn D, Kocharian R, Lim S, Meckley LM, Miyasato G, Prifti K, Rao Y, Riebman JB, Scaife JG, Soneji Y, Corral M. Reduction in hospital costs and resource consumption associated with the use of advanced topical hemostats during inpatient procedures. J Med Econ. 2015 Jun;18(6):474-81. doi: 10.3111/13696998.2015.1017503. Epub 2015 Mar 26. — View Citation

Parker WH, Wagner WH. Gynecologic surgery and the management of hemorrhage. Obstet Gynecol Clin North Am. 2010 Sep;37(3):427-36. doi: 10.1016/j.ogc.2010.05.003. Review. — View Citation

Raga F, Sanz-Cortes M, Bonilla F, Casañ EM, Bonilla-Musoles F. Reducing blood loss at myomectomy with use of a gelatin-thrombin matrix hemostatic sealant. Fertil Steril. 2009 Jul;92(1):356-60. doi: 10.1016/j.fertnstert.2008.04.038. Epub 2009 May 6. — View Citation

Ribeiro SC, Reich H, Rosenberg J, Guglielminetti E, Vidali A. Laparoscopic myomectomy and pregnancy outcome in infertile patients. Fertil Steril. 1999 Mar;71(3):571-4. — View Citation

Santulli P, Marcellin L, Touboul C, Ballester M, Darai E, Rouzier R. Experience with TachoSil in obstetric and gynecologic surgery. Int J Gynaecol Obstet. 2011 May;113(2):112-5. doi: 10.1016/j.ijgo.2010.11.019. Epub 2011 Mar 30. — View Citation

Shander A, Kaplan LJ, Harris MT, Gross I, Nagarsheth NP, Nemeth J, Ozawa S, Riley JB, Ashton M, Ferraris VA. Topical hemostatic therapy in surgery: bridging the knowledge and practice gap. J Am Coll Surg. 2014 Sep;219(3):570-9.e4. doi: 10.1016/j.jamcollsurg.2014.03.061. Epub 2014 Jun 2. Review. — View Citation

Spangler D, Rothenburger S, Nguyen K, Jampani H, Weiss S, Bhende S. In vitro antimicrobial activity of oxidized regenerated cellulose against antibiotic-resistant microorganisms. Surg Infect (Larchmt). 2003 Fall;4(3):255-62. — View Citation

Wysham WZ, Roque DR, Soper JT. Use of topical hemostatic agents in gynecologic surgery. Obstet Gynecol Surv. 2014 Sep;69(9):557-63. doi: 10.1097/OGX.0000000000000106. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Bleeding at Specified Time Intervals	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.	4 minutes, 7 minutes and 10 minutes
Secondary	Total Intraoperative Time	Total intraoperative was collected from medical record.	up to 4 hours
Secondary	Rate of Intraoperative Blood Loss	Intraoperative blood loss data was collected from medical record.	up to 4 hours
Secondary	Blood Transfusion	Blood transfusion details was collected from medical record.	up to 4 hours
Secondary	Total Postoperative Symptomatic Fluid Collection	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.	through study completion, an average of 6 weeks
Secondary	Number of Participants With Postoperative Pelvic Abscess	Postoperative pelvic abscess data was collected from medical record.	through study completion, an average of 6 weeks