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

Sponsor:	Innocoll Technologies
Collaborators:	Duke University Premier Research Group plc
Information provided by (Responsible Party):	Innocoll Technologies
ClinicalTrials.gov Identifier:	NCT00600925

Purpose

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.

Condition	Intervention	Phase
Colorectal Surgery Surgical Wound Infection	Drug: gentamicin-collagen sponge dipped in saline	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	A Randomized, Controlled, Phase 3 Study of Gentamicin-Collagen Sponge in General Surgical Subjects at Higher Risk for Surgical Wound Infection

Resource links provided by NLM:

Drug Information available for: Gentamicin sulfate

U.S. FDA Resources

Further study details as provided by Innocoll Technologies:

Primary Outcome Measures:

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. [ Time Frame: Through 60 days after surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The effect of the gentamicin-collagen sponge on the proportion of patients with surgically treated surgical wound infections adjudicated by an independent blinded committee [ Time Frame: Through 60 days after surgery ] [ Designated as safety issue: No ]
The effect of the gentamicin-collagen sponge on the proportion of patients with deep incisional surgical wound infection based on CDC criteria adjudicated by an independent blinded committee. [ Time Frame: Through 60 days after surgery ] [ Designated as safety issue: No ]
The effect of the gentamicin-collagen sponge on the proportion of patients with superficial incisional surgical wound infection based on CDC criteria adjudicated by an independent blinded committee. [ Time Frame: Through 60 days after surgery ] [ Designated as safety issue: No ]
The effect of the gentamicin-collagen sponge on type of pathogen/bacteriology [ Time Frame: Through 60 days after surgery ] [ Designated as safety issue: No ]
The effect of the gentamicin-collagen sponge on the ASEPSIS score [ Time Frame: Through 60 days after surgery ] [ Designated as safety issue: No ]
The effect of the gentamicin-collagen sponge on length of hospital stay postoperatively. [ Time Frame: Immediate post operative period ] [ Designated as safety issue: No ]
The effect of the gentamicin-collagen sponge on rehospitalization for surgical wound infection. [ Time Frame: Through 60 days after surgery ] [ Designated as safety issue: No ]
The effect of the gentamicin-collagen sponge on the total hospitalization related costs. [ Time Frame: Through 60 days after surgery ] [ Designated as safety issue: No ]
Serum gentamicin levels in subjects receiving gentamicin-collagen sponge. [ Time Frame: Approx. 24 and 48 hours post insertion of sponge ] [ Designated as safety issue: Yes ]
Serum gentamicin levels in subjects receiving reapplication of gentamicin-collagen sponge in cases of early reoperation. [ Time Frame: Approx. 24 and 48 hours post insertion of sponge ] [ Designated as safety issue: Yes ]
Subject self-reported assessment of pain and wound healing based on a structured wound healing questionnaire. [ Time Frame: 30 and 60 days after surgery ] [ Designated as safety issue: Yes ]
Change in serum creatinine from baseline to peak. [ Time Frame: Through postop Day 7 or hospital discharge if earlier ] [ Designated as safety issue: Yes ]
Incidence of reported serious and nonserious AEs, including, but not limited to, development of renal failure, ileus, anastomitic leakage, and small-bowel obstruction. [ Time Frame: Through 60 days after surgery ] [ Designated as safety issue: Yes ]
All-cause mortality [ Time Frame: 30 days and 60 days after surgery ] [ Designated as safety issue: Yes ]
Emergency Room and/or surgical office visits secondary to wound complaints. [ Time Frame: Through 60 days after surgery ] [ Designated as safety issue: Yes ]
The amount of pain medications administered [ Time Frame: During the first 3 days after surgery ] [ Designated as safety issue: Yes ]

Enrollment:	600
Study Start Date:	January 2008
Study Completion Date:	September 2010
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Insertion of 2 gentamicin-collagen sponges before closure of the laparotomy (each 10 x 10 cm sponge contains 280 mg collagen and 130 mg gentamicin).	Drug: gentamicin-collagen sponge dipped in saline 2 gentamicin-collagen sponges inserted before closure of the laparotomy
No Intervention: 2 Standard of care, ie, no gentamicin-collagen sponge.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00600925

Show 39 Study Locations

Sponsors and Collaborators

Innocoll Technologies

Duke University

Premier Research Group plc

Investigators

Study Director:

David Prior

Innocoll Technologies

More Information

No publications provided by Innocoll Technologies

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bennett-Guerrero E, Pappas TN, Koltun WA, Fleshman JW, Lin M, Garg J, Mark DB, Marcet JE, Remzi FH, George VV, Newland K, Corey GR; SWIPE 2 Trial Group. Gentamicin-collagen sponge for infection prophylaxis in colorectal surgery. N Engl J Med. 2010 Sep 9;363(11):1038-49.

Responsible Party:	Innocoll Technologies
ClinicalTrials.gov Identifier:	NCT00600925 History of Changes
Other Study ID Numbers:	INN-SWI-002
Study First Received:	January 14, 2008
Last Updated:	March 22, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Innocoll Technologies:

Colorectal surgery

Additional relevant MeSH terms:

Surgical Wound Infection
Wound Infection
Infection
Postoperative Complications
Pathologic Processes
Wounds and Injuries
Gentamicins

Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2012