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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
602
2 gentamicin-collagen sponges inserted before closure of the laparotomy
Number of Participants With Surgical Wound Infections From Surgery Through Post-operative Day 60
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: assessed at Postop Day 1, 2, 3, 7, 30 & 60
Number of Participants Who Had Superficial Incisional Surgical Wound Infection
Number of Participants who had superficial incisional surgical wound infection, based on CDC criteria adjudicated by an independent blinded committee
Time frame: assessed at Postop Day 1, 2, 3, 7, 30 & 60
The Effect of the Gentamicin-collagen Sponge on the Proportion of Patients With Deep Incisional Surgical Wound Infection
The proportion of subjects who had deep incisional SWI, based on Centers for Disease Control and Prevention (CDC) criteria adjudicated by an independent blinded committee
Time frame: assessed at Postop Day 1, 2, 3, 7, 30 & 60
The Effect of the Gentamicin-collagen Sponge on the ASEPSIS Score
Mean (SD) ASEPSIS Score Through 60 Days Postoperatively - brief assessment of surgical wound on post-operative Days 3, 4, 5, 6, and 7 (or discharge if earlier) and then questionnaire/phone call on post-operative Days 30 and 60. Score from each time point is added up and the mean score is reported. Used to compare antibiotic regimens for their effectiveness in preventing or treating wound sepsis, well-defined criteria for outcome are needed. A method of assessing wound healing has been devised that defines carefully the characteristics to be considered and how they are to be awarded points. Objective criteria are also included in the assessment. Points are given for the need for Additional treatment, the presence of Serous discharge, Erythema, Purulent exudate, and Separation of the deep tissues, the Isolation of bacteria, and the duration of inpatient Stay (ASEPSIS). The higher the points the worse outcome. Maximum Points would be 60. Minimum points would be 0
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Unnamed facility
Florence, Alabama, United States
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Mobile, Alabama, United States
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Laguna Hills, California, United States
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Los Angeles, California, United States
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Stanford, California, United States
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Aurora, Colorado, United States
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Denver, Colorado, United States
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Tampa, Florida, United States
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Weston, Florida, United States
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Atlanta, Georgia, United States
...and 29 more locations
Time frame: Days 3, 4, 5, 6, and 7 (or discharge if earlier) and then questionnaire/phone call on post-operative Days 30 and 60.
The Effect of the Gentamicin-collagen Sponge on Length of Hospital Stay Postoperatively.
Time frame: Immediate post operative period
Number of Participants Who Were Rehospitalized for Surgical Wound Infection Within 60 Days Post-operatively
The effect of the gentamicin-collagen sponge on rehospitalization for surgical wound infection.
Time frame: Through 60 days after surgery