NCT02232178

Pharmacokinetics, Relative Bioavailability and Safety of Xaracoll Implant

A Randomized, Blinded, Inpatient Study to Investigate the PK, Relative Bioavailability and Safety of 2 Doses of XaraColl (200 and 300 mg Bupivacaine HCl) Compared to Bupivacaine HCl Infiltration (150 mg) After Open Laparotomy Hernioplasty

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Innocoll · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 hernioplasty remain considerable medical challenges. Bupivacaine is a local anesthetic (pain medicine) that has an established safety profile. Collagen is a protein that is found in all mammals. The Xaracoll implant is a thin flat sponge made out of collagen that comes from cow tendons and contains bupivacaine. When inserted into a surgical site, the collagen breaks down and bupivacaine is released at the surgical site to provide postoperative pain control. This study will assess the pharmacokinetic profile of 2 doses of the XaraColl implant after open laparotomy hernioplasty and assess the relative bioavailability of the Xaracoll implant compared to a local bupivacaine infiltration.

Conditions

• Hernioplasty

Interventions

Type	Name	Description
DRUG	2 100mg Xaracoll implants
DRUG	3 100mg Xaracoll implants
DRUG	150mg Bupivacaine HCl injection

Timeline

• Start date: 2014-10-20
• Primary completion: 2015-02-23
• Completion: 2015-03-23
• First posted: 2014-09-05
• Last updated: 2020-10-20
• Results posted: 2018-08-23

Locations

5 sites across 1 country: United States