Status:
COMPLETED
Pharmacokinetics, Relative Bioavailability and Safety of Xaracoll Implant
Lead Sponsor:
Innocoll
Collaborating Sponsors:
Premier Research
Conditions:
Hernioplasty
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Assess the pharmacokinetic profile of 2 doses of the XaraColl® implant after open laparotomy hernioplasty and assess the relative bioavailability of Xaracoll compared to a local bupivacaine infiltrati...
Detailed Description
Inguinal hernioplasty is a common surgery. Common surgical methods used include laparoscopic and open placement of synthetic mesh. Managing postoperative pain and preventing morbidity after open mesh ...
Eligibility Criteria
Inclusion
- Man or woman who is ≥ 18 years of age
- Has a planned unilateral inguinal hernioplasty (open laparotomy, tension free technique)
- If female, is nonpregnant
Exclusion
- Scheduled for bilateral inguinal hernioplasty or other significant concomitant surgical procedures
- Has undergone major surgery within 3 months of the scheduled hernioplasty or plans to undergo another laparotomy procedure within 30 days postoperatively
- Has any clinically significant unstable cardiac, neurological, immunological, renal, hepatic or hematological disease or any other condition that, in the opinion of the investigator, could compromise the patient's welfare, ability to communicate with the study staff or otherwise contraindicate study participation
Key Trial Info
Start Date :
October 20 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 23 2015
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT02232178
Start Date
October 20 2014
End Date
March 23 2015
Last Update
October 20 2020
Active Locations (5)
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1
Pinnacle Research Group
Anniston, Alabama, United States, 36207
2
Shoals Medical Trials
Sheffield, Alabama, United States, 35660
3
Wexner Medical Center at Ohio State University
Columbus, Ohio, United States, 43210
4
First Surgical Hospital
Bellaire, Texas, United States, 77401