Pharmacokinetics, Relative Bioavailability and Safety of Xaracoll Implant

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-20

Study Completion Date

2015-03-23

Brief Summary

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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.

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Detailed Description

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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

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Hernioplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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2 100mg Xaracoll implants

Bupivacaine HCl implant

Group Type EXPERIMENTAL

2 100mg Xaracoll implants

Intervention Type DRUG

3 100mg Xaracoll implants

Bupivacaine HCl implant

Group Type EXPERIMENTAL

3 100mg Xaracoll implants

Intervention Type DRUG

150mg Bupivacaine HCl injection

Bupivacaine HCl

Group Type ACTIVE_COMPARATOR

150mg Bupivacaine HCl injection

Intervention Type DRUG

Interventions

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2 100mg Xaracoll implants

Intervention Type DRUG

3 100mg Xaracoll implants

Intervention Type DRUG

150mg Bupivacaine HCl injection

Intervention Type DRUG

Other Intervention Names

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Bupivacaine HCl implant Bupivacaine HCl implant Bupivacaine HCl

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No