Intrauterine Use of FloSeal: Is it Safe and Useful?

January 20, 2016 updated by: David L Zisow, MD, David L Zisow MD LLC

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Randallstown, Maryland, United States, 21133
        • Northwest Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Exclusion Criteria:Malignancy Inability to remove uterus without morcellation

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Procedure: Hysterectomy with FloSeal
Evaluation of the effects of intrauterine 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
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
Evaluation of the effects of intrauterine 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tissue effects of FloSeal upon endometrium on day 1
Time Frame: Immediate post operative effects
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.
Immediate post operative effects

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

David L Zisow MD LLC

Investigators

  • Principal Investigator: David L Zisow, MD, Lifebridge Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (ACTUAL)

April 1, 2015

Study Completion (ACTUAL)

April 1, 2015

Study Registration Dates

First Submitted

December 6, 2012

First Submitted That Met QC Criteria

December 8, 2012

First Posted (ESTIMATE)

December 11, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 21, 2016

Last Update Submitted That Met QC Criteria

January 20, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1971

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Operative Hemorrhage

Clinical Trials on Hysterectomy with FloSeal

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe