Clinical trial NCT01746628: Intrauterine Use of FloSeal: Is it Safe and Useful?
Official title: Intrauterine Use of FloSeal: Is it Safe and Useful?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Operative Hemorrhage
Keywords: type 0 myomata
type 1 myomata
type 2 myomata
bleeding
hemorrhage
hysteroscopy
FloSeal
Lead sponsor: David L Zisow MD LLC
Sponsor class: INDUSTRY
First posted: 2012-12-11
Enrollment: 14
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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

Exclusion Criteria:Malignancy Inability to remove uterus without morcellation

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Primary outcomes:
measure: Tissue effects of FloSeal upon endometrium on day 1
timeFrame: Immediate post operative effects
Secondary outcomes:
Other outcomes:
Locations:
city: Randallstown
country: United States
facility: Northwest Hospital
state: Maryland
Study officials:
affiliation: LifeBridge Health
name: David L Zisow, MD
role: PRINCIPAL_INVESTIGATOR
References: