Operative Hemorrhage Clinical Trial
Official title:
Intrauterine Use of FloSeal: Is it Safe and Useful?
| Verified date | January 2016 |
| Source | David L Zisow MD LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 14 |
| Est. completion date | April 2015 |
| Est. primary completion date | April 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria:Women undergoing hysterectomy for non-malignant indications - Exclusion Criteria:Malignancy Inability to remove uterus without morcellation |
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Northwest Hospital | Randallstown | Maryland |
| Lead Sponsor | Collaborator |
|---|---|
| David L Zisow MD LLC |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Tissue effects of FloSeal upon endometrium on day 1 | 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 | No |