A Study of an Antibiotic Implant in General Surgical Subjects at Higher Risk for Surgical Wound Infection

Condition(s) targeted: Colorectal Surgery; Surgical Wound Infection

Intervention: gentamicin-collagen sponge (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Innocoll Technologies

Official(s) and/or principal investigator(s):
David Prior, Study Director, Affiliation: Innocoll Technologies

Overall contact:
David Prior, Phone: 1-866-208-1686, Email: clinicaltrials@innocoll-tech.com

The purpose of this study is to determine whether the gentamicin-collagen sponge is safe and effective for preventing surgical wound infections in patients undergoing colorectal surgery.

Official title: A Randomized, Controlled, Phase 3 Study of Gentamicin-Collagen Sponge (Collatamp® G) in General Surgical Subjects at Higher Risk for Surgical Wound Infection

Study design: Prevention, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Primary outcome: Primarily, efficacy will be evaluated by a comparison between the 2 study groups of the incidence of surgical wound infections (involving the laparotomy incision) that occur within the period from surgery through postop day 60.

Secondary outcome:

The effect of Collatamp G the on the proportion of patients with surgically treated surgical wound infections adjudicated by an independent blinded committee

The effect of Collatamp G the on the proportion of patients with deep incisional surgical wound infection based on CDC criteria adjudicated by an independent blinded committee.

The effect of Collatamp G the on the proportion of patients with superficial incisional surgical wound infection based on CDC criteria adjudicated by an independent blinded committee.

The effect of Collatamp G the on the proportion of patients with deep incisional surgical wound infection based on CDC criteria adjudicated by an independent blinded committee.

The effect of Collatamp G the on type of pathogen/bacteriology

The effect of Collatamp G the on the ASEPSIS score

The effect of Collatamp G on length of hospital stay postoperatively.

The effect of Collatamp G on rehospitalization for surgical wound infection.

The effect of Collatamp G the total hospitalization related costs.

Serum gentamicin levels in subjects receiving gentamicin-collagen sponge.

Serum gentamicin levels in subjects receiving reapplication of gentamicin-collagen sponge in cases of early reoperation.

Subject self-reported assessment of pain and wound healing based on a structured wound healing questionnaire.

Change in serum creatinine from baseline to peak.

Incidence of reported serious and nonserious AEs, including, but not limited to, development of renal failure, ileus, anastomitic leakage, and small-bowel obstruction.

All-cause mortality

Emergency Room and/or surgical office visits secondary to wound complaints.

The amount of pain medications administered

Detailed description: Surgical wound infection (SWI) is a significant problem in colorectal surgery. Despite the use of routine bowel preparation and prophylactic antibiotics the incidence of SWI is at least 15% in patients undergoing colorectal surgical procedures. Therefore, there is a long unmet need for an intervention that can reduce the incidence and severity of SWIs in patients undergoing colorectal surgery.

Gentamicin is an antibiotic that is effective in treating certain kinds of infection. Collagen is a protein that is found in all mammals. The gentamicin-collagen sponge is a thin flat sponge made out of collagen that comes from cow tendons and containing gentamicin. When inserted into a surgical site, the collagen breaks down and the gentamicin is released at the site but very little is absorbed into the blood stream. The high levels of antibiotic at the surgical site may prevent an infection at the surgical site.

Outside of the United States more than 3,500 subjects have received treatment in clinical studies with the gentamicin-collagen sponge, primarily for orthopedic, intraabdominal, and cardiothoracic surgeries or wound infections following surgical procedures or traumatic events.

In this study, all subjects will be given treatment that is normally given to prevent surgical infections. For subjects randomly assigned to the gentamicin-collagen sponge treatment group, 2 sponges will be inserted into the surgical wound immediately before the surgeon closes it. The control group will receive no collagen sponge.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Scheduled to undergo nonemergent colon and/or rectal surgical procedures involving a

laparotomy incision of at least 7 cm in length or greater. List of eligible procedures: Left Hemicolectomy, Transverse Colectomy, Segmental/Sleeve Left Colon Resection, Total Abdominal Colectomy With Ileorectal Anastomosis, Total Abdominal Colectomy With Ileostomy, Total Abdominal Proctocolectomy (Portion Of Specimen To Be Extracted Via Laparotomy), Low Anterior Resection, Sigmoid Resection, Non-Emergent Hartmann's Procedure, Colotomy With Polypectomy Distal To Hepatic Flexure, Colostomy Takedown Through Laparotomy (Not Peristomal) Incision, Ileo-Pouch Anal Anastomosis, Abdominal Perineal Resection of the Rectum

- Have the capacity to understand and sign an informed consent form.

- Are male or female and > 18 years of age.

- If female, be postmenopausal (no menstrual period for a minimum of 1 year), or

surgically sterilized (does not have a uterus or has had bilateral tubal ligation). Females of child-bearing potential must have a negative serum pregnancy test on entry in the study, and agree to use adequate birth control during the study and for 60 days after the administration of study agent.

- Agree to be available for evaluation from baseline until final evaluation at 60 days

postsurgery.

Exclusion Criteria:

- Known history of hypersensitivity to gentamicin or bovine collagen.

- Undergoing emergency surgery (urgent surgery is allowed if informed consent is

obtained and the study procedures can be performed). Emergency surgery includes cases where standard bowel preparation and other preoperative assessments cannot be done.

- Undergoing a significant concomitant surgical procedure (e. g., hysterectomy). The

following concomitant procedures are allowed: appendectomy, cholecystectomy, oophorectomy, liver biopsy/wedge resection (but not liver resection).

- Undergoing a laparoscopic, laparoscopic-assisted, or other minimally invasive surgical

approach involving a laparotomy incision less than 7 cm.

- History of prior laparotomy within the last 60 days of this planned procedure.

- Planned to undergo a second laparotomy or colorectal surgical procedure (e. g.

colostomy or ileostomy takedown) within 60 days of this planned first procedure.

- Evidence preoperatively of any of the following: sepsis, severe sepsis, or septic

shock (note that SIRS alone is not an exclusion criterion)

- Current abdominal wall infection/surgical site infection from previous

laparotomy/laparoscopy or for any reason.

- Receiving antibiotic therapy within the 1 week prior to the date of surgery.

- Preoperative evaluation suggests intra-abdominal process that might preclude full

closure of the skin.

- History of ongoing treatment (e. g. chemotherapy, radiation) for non-colorectal

cancer.

- Recent history of significant drug or alcohol abuse.

- Preoperative prothrombin time (PT) > 1. 5 times upper limit of normal

- Pregnant, lactating, or of childbearing potential not practicing a birth control

method with a high degree of reliability

- Postsurgical life expectancy ≤ 60 days, in the investigator's or sponsor's opinion.

- Refusal to accept medically indicated blood products.

- Previous participation in this or any other active Innocoll Gentamicin-Collagen Sponge

study.

- Participation within 30 days before the start of this study in any experimental drug

or device study, or currently participating in a study in which the administration of investigational drug or device within 60 days is anticipated.

- Surgeon does not believe that it will be possible to insert 2 sponges above the fascia

in the patient (e. g. in a very thin patient planned to have a small incision)

- Patients with anterior abdominal wall mesh that is not planned to be completely

removed during the planned procedure.

- Presence of prosthetic cardiac valve.

David Prior, Phone: 1-866-208-1686, Email: clinicaltrials@innocoll-tech.com

Mobile, Alabama, United States; Recruiting

Florence, Alabama, United States; Recruiting

Los Angeles, California, United States; Recruiting

Laguna Hills, California, United States; Recruiting

Stanford, California, United States; Recruiting

Aurora, Colorado, United States; Recruiting

Denver, Colorado, United States; Recruiting

Tampa, Florida, United States; Recruiting

Weston, Florida, United States; Recruiting

Atlanta, Georgia, United States; Not yet recruiting

Indianapolis, Indiana, United States; Recruiting

Louisville, Kentucky, United States; Recruiting

New Orleans, Louisiana, United States; Recruiting

Baltimore, Maryland, United States; Recruiting

Detroit, Michigan, United States; Recruiting

Duluth, Minnesota, United States; Recruiting

Minneapolis, Minnesota, United States; Recruiting

St. Louis, Missouri, United States; Active, not recruiting

Syracuse, New York, United States; Recruiting

Albany, New York, United States; Recruiting

Brooklyn, New York, United States; Recruiting

New York, New York, United States; Recruiting

Durham, North Carolina, United States; Recruiting

Greensboro, North Carolina, United States; Recruiting

Chapel Hill, North Carolina, United States; Recruiting

Cincinnati, Ohio, United States; Recruiting

Cleveland, Ohio, United States; Recruiting

Colombus, Ohio, United States; Recruiting

Oklahoma City, Oklahoma, United States; Recruiting

Portland, Oregon, United States; Recruiting

Hershey, Pennsylvania, United States; Recruiting

Philadelphia, Pennsylvania, United States; Recruiting

Nashville, Tennessee, United States; Recruiting

Houston, Texas, United States; Recruiting

Dallas, Texas, United States; Recruiting

Temple, Texas, United States; Recruiting

Burlington, Vermont, United States; Recruiting

Tacoma, Washington, United States; Recruiting

Seattle, Washington, United States; Recruiting

Starting date: January 2008
Ending date: March 2009
Last updated: February 3, 2009