Phase 2
Completed N=64
Pharmacokinetics, Relative Bioavailability and Safety of Xaracoll Implant
Hernioplasty
Source: ClinicalTrials.gov NCT02232178 ↗
Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcomePrimary: Cmax — 340.4; 524.8; 348.4 ng/mL
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 infiltration.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax |
340.4; 524.8; 348.4 | — |
| PRIMARY AUC0-last |
10793.449; 18589.907; 8323.188 | — |
| PRIMARY Tmax |
7.271; 8.567; 8.783 | — |
| PRIMARY t1/2 (Hour) |
16.922; 18.058; 8.819 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02232178). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.