A randomised, controlled prospective open parallel groups clinical trial for the evaluation of efficacy and safety of TachoSil® in women undergoing hysterectomy. A pilot study - TachoSil® for haemostasis in gynaecology.
Phase 1
- Conditions
- It is the intention with this clinical trial to evaluate wheter TachoSil may reduce the formation of postoperative haematomas on the vaginal cuff following hysterectomi. The presence of a postoperative haematoma is correlated to postoperative complications such as fever, abdomimal pain and prolonged recovery. It the incidence of haematomas may be reduced, the number of postoperative complications is expected to be reduced as well.MedDRA version: 9.1Level: LLTClassification code 10044080Term: Total abdominal hysterectomy
- Registration Number
- EUCTR2008-005549-46-DK
- Lead Sponsor
- Hvidovre Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 50
Inclusion Criteria
Subject aged 18 or above?
Informed written consent?
Elective abdominal hysterectomy for on benign indication
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
History of allergic reactions after applications of human fibrinogen, human thrombin and/or collagen of any origin
Participation in a clinical trial less than 30 days prior to inclusion in present trial.
Participation in a clinical trial concomitantly with present trial.
Intraoperative use of Cyclocapron
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method