Clinical trial NCT02232178: Pharmacokinetics, Relative Bioavailability and Safety of Xaracoll Implant
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hernioplasty
Keywords: unilateral inguinal hernioplasty
Lead sponsor: Innocoll
Sponsor class: INDUSTRY
Collaborators: name: Premier Research Group plc
First posted: 2014-09-05
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cmax
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours after surgery.
measure: AUC0-last
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours after surgery.
measure: Tmax
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours after surgery.
measure: t1/2 (Hour)
timeFrame: 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 36, 48, 72, and 96 hours after surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group
state: Alabama
city: Sheffield
country: United States
facility: Shoals Medical Trials
state: Alabama
city: Columbus
country: United States
facility: Wexner Medical Center at Ohio State University
state: Ohio
city: Bellaire
country: United States
facility: First Surgical Hospital
state: Texas
city: Houston
country: United States
facility: Victory Hospital
state: Texas
Study officials:
affiliation: Innocoll
name: Gwendolyn Niebler, D.O.
role: STUDY_DIRECTOR
References: