Laparoscopic HysterectomyNCT02908841
Surgicel Snow in Gynecological Surgery
A study testing Surgicel Snow in people with Laparoscopic Hysterectomy, run by Danbury Hospital at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Laparoscopic Hysterectomy
- What is being tested?
- Surgicel Snow
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2016to 11 Feb 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Danbury Hospital
Danbury, Connecticut, 06810
Physicians for Women's Health
Norwalk, Connecticut, 06850
Norwalk Hospital
Norwalk, Connecticut, 06856
About this study
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.
Read the 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
- Being tested
- Surgicel Snow, Standard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgicel SnowDevice
Standard of CareOther
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | 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. Receives: Other: Standard of Care |
| Treatment | Other | 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. Receives: Device: Surgicel Snow |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 minutes, 7 minutes and 10 minutes
Secondary outcomes (5)
Total Intraoperative Time
Total intraoperative was collected from medical record.
Measured: up to 4 hours
Rate of Intraoperative Blood Loss
Intraoperative blood loss data was collected from medical record.
Measured: up to 4 hours
Blood Transfusion
Blood transfusion details was collected from medical record.
Measured: up to 4 hours
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.
Measured: through study completion, an average of 6 weeks
Number of Participants With Postoperative Pelvic Abscess
Postoperative pelvic abscess data was collected from medical record.
Measured: through study completion, an average of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study startJul 2016
- Primary completionSep 2018
- Study completion11 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic HysterectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danbury Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ethicon, Inc.
- Responsible party
- Principal investigator, Joann Petrini, PhD, MPH, Danbury Hospital
- Investigators
- Joann Petrini, PhD, Study chair, Nuvance Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02908841
- Sponsor's protocol ID
- 16-02-37-337
- Status last verified
- Jul 2021
- First submitted
- 7 Sep 2016
- Last updated
- 14 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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. doi: 10.1089/109629603322419599.
PubMed 14588160Martyn 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.
PubMed 25728820Ata 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.
PubMed 25573183Santulli 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.
PubMed 21453918Angioli 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.
PubMed 19138574Ribeiro 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. doi: 10.1016/s0015-0282(98)00483-x.
PubMed 10065802Raga F, Sanz-Cortes M, Bonilla F, Casan 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.
PubMed 19423098Angioli 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.
PubMed 22302534Shander 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. No abstract available.
PubMed 25151345Wysham 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.
PubMed 25229825Parker 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.
PubMed 20674784
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgicel Snow in Gynecological Surgery
- ClinicalTrials.gov ID
- NCT02908841
- Acronym / sponsor ID
- 16-02-37-337
- Conditions
- Laparoscopic Hysterectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Danbury HospitalUniversity, hospital or other
- Collaborators
- Ethicon, Inc.
- Study start
- Jul 2016 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- 11 Feb 2019 (actual)
- First posted
- 21 Sep 2016 (estimated)
- Results
- Posted 3 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: Standard of Care30 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. |
| Treatment | Other | Device: Surgicel Snow30 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgicel Snow | Device | Treatment |
| Standard of Care | Other | Control |
Primary outcome
Change in Bleeding at Specified Time Intervals
Time frame: 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.
5 secondary outcomes
Total Intraoperative Time
Time frame: up to 4 hours
Rate of Intraoperative Blood Loss
Time frame: up to 4 hours
Blood Transfusion
Time frame: up to 4 hours
Total Postoperative Symptomatic Fluid Collection
Time frame: through study completion, an average of 6 weeks
Number of Participants With Postoperative Pelvic Abscess
Time frame: through study completion, an average of 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 14588160Spangler 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. doi: 10.1089/109629603322419599.
- Background: PubMed 25728820Martyn 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.
- Background: PubMed 25573183Ata 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.
- Background: PubMed 21453918Santulli 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.
- Background: PubMed 19138574Angioli 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.
- Background: PubMed 10065802Ribeiro 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. doi: 10.1016/s0015-0282(98)00483-x.
- Background: PubMed 19423098Raga F, Sanz-Cortes M, Bonilla F, Casan 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.
- Background: PubMed 22302534Angioli 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.
- Background: PubMed 25151345Shander 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. No abstract available.
- Background: PubMed 25229825Wysham 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.
- Background: PubMed 20674784Parker 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joann Petrini, PhD study chair
Nuvance Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgicel Snow in people with Laparoscopic Hysterectomy, run by Danbury Hospital at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Bleeding at Specified Time Intervals (time frame: 4 minutes, 7 minutes and 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02908841, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2021.