Pharmacokinetics, Relative Bioavailability and Safety of Xaracoll Implant

Innocoll64 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Hernioplasty

Interventions

2 100mg Xaracoll implantsDRUG

3 100mg Xaracoll implantsDRUG

150mg Bupivacaine HCl injectionDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

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

Outcomes

Primary Outcomes

Cmax

Maximum drug plasma concentration

Time frame: 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours after surgery.

AUC0-last

Area under the plasma concentration-time curve from Time 0 to time of last quantifiable plasma concentration.

Time frame: 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours after surgery.

Tmax

Time to maximum plasma concentration.

Time frame: 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours after surgery.

t1/2 (Hour)

Terminal half-life.

Time frame: 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours after surgery.

Data from ClinicalTrials.gov

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