A Study of an Antibiotic Implant in General Surgical Subjects at Higher Risk for Surgical Wound Infection
Condition: Colorectal Surgery; Surgical Wound Infection
MeSH terms: Infections; Communicable Diseases; Wound Infection; Surgical Wound Infection; Wounds and Injuries; Surgical Wound
Intervention: gentamicin-collagen sponge dipped in saline
Intervention description: 2 gentamicin-collagen sponges inserted before closure of the laparotomy
Intervention MeSH terms: Gentamicins
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 602.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Colorectal surgery

Summary:

      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.
    

Eligibility 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.