Intrauterine Use of FloSeal: Is it Safe and Useful?

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by David L Zisow MD LLC
Sponsor:
Information provided by (Responsible Party):
David L Zisow, MD, David L Zisow MD LLC
ClinicalTrials.gov Identifier:
NCT01746628
First received: December 6, 2012
Last updated: August 5, 2013
Last verified: August 2013
  Purpose

When having certain types of outpatient surgery inside the uterine cavity some women experience heavy bleeding. The only method presently available for controlling such bleeding, short of removing the uterus, involves the placement of a balloon pressure device inside the uterine cavity. The pressure along with the patient's own natural clotting ability will generally stop the bleeding. However, this treatment usually requires at least a 24 hour stay in the hospital. The investigators are researching the use of a compound (FloSeal) already approved for use in other areas of the human body, as a method of controlling bleeding. The use of FloSeal in the uterine cavity has not yet been tested and therefore is not yet an FDA approved indication for its safe use to control bleeding from the uterine cavity. In this study, The investigators want to find out what effect(s) FloSeal has on the uterine cavity.

Twenty individuals will be included in this study at Northwest Hospital Center. All twenty individuals will be treated in the same fashion except ten of the participants will randomly be assigned to receive FloSeal and ten will not.

Study participants are individuals currently scheduled to have a hysterectomy procedure, which involves surgically removing the uterus from the body for a previously determined standard of care treatment for a non- cancerous medical problem. Before performing the hysterectomy and evaluating the effects of FloSeal upon the tissues within the uterine cavity the following will be done. Once under anesthesia the uterine cavity will be subjected to a curettage (sharp scrapping) to produce a minor amount of bleeding from the lining of the uterus. Ten of the 20 study participants, randomly chosen, will then have FloSeal placed into their uterine cavity. The study participants will not know whether they received FloSeal or not. A balloon pressure device will then be placed into the uterine cavity of all 20 individuals and left in place for 5 minutes. After the allotted time, the balloon device will be removed. The hysterectomy will then be completed appropriately using standard methods and techniques. The uterus, once removed will be evaluated pathologically to determine the effects of the FloSeal upon the tissues of the cavity in those so treated and compared to the same analysis in those individuals who did not receive FloSeal. The pathologist will not know which patients received or did not receive FloSeal.

This use of FloSeal is not currently an FDA approved use of the compound. The goal of this study is to obtain FDA approval for use in this situation.


Condition Intervention
Operative Hemorrhage
Procedure: Hysterectomy with FloSeal

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intrauterine Use of FloSeal: Is it Safe and Useful?

Resource links provided by NLM:


Further study details as provided by David L Zisow MD LLC:

Primary Outcome Measures:
  • Tissue effects of FloSeal upon endometrium on day 1 [ Time Frame: Immediate post operative effects ] [ Designated as safety issue: No ]
    Pathological (microscopic and histochemical) evaluation of endometrial curettings and uterine specimens in all study cases to evaluate immediate (day 1) tissue effects of FloSeal upon the endometrium.


Estimated Enrollment: 20
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Hysterectomy without FloSeal
Endometrial curettage Intrauterine foley balloon placement for 5 minutes Removal of intrauterine foley balloon Saline irrigation of uterine cavity Hysterectomy
Active Comparator: Hysterectomy with FloSeal
Endometrial curettage FloSeal placement into uterine cavity Intrauterine foley balloon placement for 5 minutes Removal of intrauterine foley balloon Saline irrigation of uterine cavity Hysterectomy
Procedure: Hysterectomy with FloSeal
Other Names:
  • Endometrial curettage
  • FloSeal placement into uterine cavity
  • Intrauterine foley balloon placement for 5 minutes
  • Removal of intrauterine foley balloon
  • Saline irrigation of uterine cavity
  • Hysterectomy

Detailed Description:

Patients will be followed until fully recovered from surgery, usually 6 to 8 weeks. Any complications will be duly noted and treated appropriately. The final end point for follow up will be when the patient is finally discharged from care having achieved what is usually perceived as a return to all normal activity.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:Women undergoing hysterectomy for non-malignant indications -

Exclusion Criteria:Malignancy Inability to remove uterus without morcellation

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01746628

Contacts
Contact: David L Zisow, MD 410-879-1139 dzisow@verizon.net
Contact: Janette Z Davison, MD 410-879-1139 janette.z.davison@gmail.com

Locations
United States, Maryland
Northwest Hospital Recruiting
Randallstown, Maryland, United States, 21133
Sponsors and Collaborators
David L Zisow MD LLC
Investigators
Principal Investigator: David L Zisow, MD LifeBridge Health
  More Information

No publications provided

Responsible Party: David L Zisow, MD, Gynecologist and Assoc. Chief of Minimally Invasive Surgery, David L Zisow MD LLC
ClinicalTrials.gov Identifier: NCT01746628     History of Changes
Other Study ID Numbers: 1971
Study First Received: December 6, 2012
Last Updated: August 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by David L Zisow MD LLC:
type 0 myomata
type 1 myomata
type 2 myomata
bleeding
hemorrhage
hysteroscopy
FloSeal

Additional relevant MeSH terms:
Hemorrhage
Blood Loss, Surgical
Pathologic Processes
Intraoperative Complications

ClinicalTrials.gov processed this record on July 22, 2014