Intrauterine Use of FloSeal: Is it Safe and Useful?
Condition: Operative Hemorrhage
MeSH terms: Hemorrhage; Blood Loss, Surgical
Study type: Interventional

Summary: 
      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.
    

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.
    

Intervention name(s): Hysterectomy with FloSeal
Intervention type(s): Procedure
Intervention description(s): Evaluation of the effects of intrauterine FloSeal
Other intervention name(s): 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
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: type 0 myomata; type 1 myomata; type 2 myomata; bleeding; hemorrhage; hysteroscopy; FloSeal