Pharmacokinetics, Relative Bioavailability and Safety of Xaracoll Implant

Completed · Phase 2

Conditions studied: Hernioplasty

In brief

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 infiltration.

Key facts

Study ID

NCT02232178

Run by

Innocoll

People needed

64

Starts

2014-10-20

Expected to finish

2015-03-23

Last updated by the study team

2020-10-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Man or woman who is ≥ 18 years of age
• Has a planned unilateral inguinal hernioplasty (open laparotomy, tension free technique)
• If female, is nonpregnant

You may not qualify if…

• 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

Where it is running

• Pinnacle Research Group — Anniston, Alabama, United States
• Shoals Medical Trials — Sheffield, Alabama, United States
• Wexner Medical Center at Ohio State University — Columbus, Ohio, United States
• First Surgical Hospital — Bellaire, Texas, United States
• Victory Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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