Pharmacokinetics, Relative Bioavailability and Safety of Xaracoll Implant

Innocoll

Status and phase: Completed; Phase 2

Conditions: Hernioplasty

Treatments: Drug: 2 100mg Xaracoll implants; Drug: 150mg Bupivacaine HCl injection; Drug: 3 100mg Xaracoll implants

Study type: Interventional

Funder types: Industry

Identifiers

NCT02232178

INN-CB-013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Scheduled for bilateral inguinal hernioplasty or other significant concomitant surgical procedures
2. Has undergone major surgery within 3 months of the scheduled hernioplasty or plans to undergo another laparotomy procedure within 30 days postoperatively
3. 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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64 participants in 3 patient groups

2 100mg Xaracoll implants

Experimental group

Description:

Bupivacaine HCl implant

Treatment:

Drug: 2 100mg Xaracoll implants

3 100mg Xaracoll implants

Experimental group

Description:

Bupivacaine HCl implant

Treatment:

Drug: 3 100mg Xaracoll implants

150mg Bupivacaine HCl injection

Active Comparator group

Description:

Bupivacaine HCl

Treatment:

Drug: 150mg Bupivacaine HCl injection