Not Recommended for Practice

Implantable Gentamycin Sponge

for Prevention of Infection: General

Insertion of a sponge containing gentamycin along the incision line prior to surgical closure was examined in patients with cancer undergoing colorectal surgery for its effect on development of surgical infections.

Research Evidence Summaries

Bennett-Guerrero, E., Pappas, T.N., Koltun, W.A., Fleshman, J.W., Lin, M., Garg, J., . . . SWIPE 2 Trial Group. (2010). Gentamicin-collagen sponge for infection prophylaxis in colorectal surgery. New England Journal of Medicine, 363, 1038–1049.

Study Purpose

The purpose of the study was to determine if an implantable gentamicin-collagen sponge prevents surgical infections in patients undergoing colorectal surgery.

Intervention Characteristics/Basic Study Process

Patients undergoing laparoscopic colorectal surgery in one of the 39 sites participating in the trial were randomized into either the sponge group or the control group after the surgical incision was made. If randomized into the experimental group, patients had a sponge (10 x 10 cm) implanted internally along their incision line just prior to the surgeon closing the wound that contained 280 mg of collagen and 130 mg of gentamicin. Both groups received standard of care of antibiotics 60 minutes prior to incision. Individuals who analyzed results were blinded to patient assignment.

Sample Characteristics

  • The sample included 602 participants.
  • Ages ranged from 45–67 years.
  • Males made up 56% of the sample; females made up 44%.
  • Patients enrolled underwent surgery for colon or rectal cancer, diverticulitis, or inflammatory bowel disease.

Setting

Multiple sites

Phase of Care and Clinical Applications

Multiple phases of care

Study Design

Phase III blinded randomized, controlled trial

Measurement Instruments/Methods

  • ASEPSIS score through 60 days postoperatively    
  • Serum creatinine peak reported for each patient for up to the first seven days postoperatively depending on discharge date
  • Patient self-assessment of pain and wound healing 30 and 60 days postoperatively
  • Data was recorded for any enrolled patients with visits to the emergency room, physician office, or readmission to the hospital with wound-related issues
  • Serum gentamicin levels were obtained at baseline and up to 48 hours after wound closure
     

Results

Surgical infections occurred more frequently in the sponge group with a rate of 30% as compared to the control group at 20%. Superficial site infections also were higher in the sponge group than the control group. The sponge group also was more likely to visit the emergency department or physician offices with wound-related complications (19% versus 11%).

Conclusions

The gentamicin collagen sponge is not effective in preventing surgical site infections in patient undergoing colorectal surgery.

Limitations

The study did not determine if the sponge could be used to treat infection but, instead, focused only on infection prevention.

Nursing Implications

The gentamicin collagen sponge is not only not effective in preventing infection, but based on this study, may increase a patient’s risk for surgical wound infection.

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Rutkowski, A., Zajac, L., Pietrzak, L., Bednarczyk, M., Byszek, A., Oledzki, J., . . . Chwalinski, M. (2014). Surgical site infections following short-term radiotherapy and total mesorectal excision: Results of a randomized study examining the role of gentamicin collagen implant in rectal cancer surgery. Techniques in Coloproctology, 18, 921–928. 

Study Purpose

To determine the risk of surgical site infection (SSI) reduction using local gentamicin collagen implants (GCIs) following preoperative radiotherapy and total mesorectal excisions (TMEs)

Intervention Characteristics/Basic Study Process

  • Short-term radiotherapy (5 x 5 Gy) for rectal cancer preoperatively
  • A GCI was inserted into the wound after surgical excision and prior to the closure of the cavity.

Sample Characteristics

  • N = 176   
  • MEAN AGE = 63 years
  • MALES: 63.3%, FEMALES: 32.7%
  • CURRENT TREATMENT: Combination radiation and chemotherapy, other
  • KEY DISEASE CHARACTERISTICS: Rectal cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: Preoperative radiation (XRT), then surgery within six days post XRT, but pushed out to 6–8 weeks if necessary

Setting

  • SITE: Single site   
  • SETTING TYPE: Inpatient    
  • LOCATION: Warsaw, Poland

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Pediatrics, elder care

Study Design

  • Randomized, controlled trial

Measurement Instruments/Methods

  • SSI definition included superficial and organ space infections as defined by the Centers for Disease Control and Prevention (CDC)
  • Intrabdominal infections defined according to the Scottish Surveillance of Healthcare Associated Infection Program (e.g., cultures, abcesses, or other evidence of infection based on fever, symptoms, and diagnostic tests)

Results

No statistically significant differences existed between the study and control groups in early postoperative complications (25.6% and 34.1%, respectively, p = 0.245). The reoperation rate was similar in both groups: 12.8% versus 9.4%, p = 0.628, risk ratio [RR] = 1.359, 95% confidence interval [CI] [0.575, 3.212]. The total rate of SSI and organ space SSI were 22.2% and 15.8% without differences between the study and control groups. In patients without anastomotic leakage, the risk of organ space SSI was significantly reduced in patients who received the GCI: 2.6% versus 13%, p = 0.018.

Conclusions

Inconclusive: Applying the GCI in the pelvic cavity after short-term preoperative XRT and TME may reduce the risk of organ space SSI but only in the absence of anastomotic leakage.

Limitations

Postoperative complications were a secondary aim and, therefore, the study lacked adequate power. Fewer patients received GCI because of a protocol deviation. Organ space SSI was not confirmed by bacteriological swabs. Sometimes, SSI was determined by a CT or physical symptoms and, therefore, could be misconstrued as infection when it was really an inflammatory reaction. This suggests that anastomotic leakage is such a significant risk factor for organ space SSI that the application of GCI does not prevent it. Patients were not given preoperative antibiotics, which is a current standard of care.

Nursing Implications

Nursing implications for this are clearly good surgical patient care postoperatively, such as using the aseptic technique while changing dressings; encouraging walking to prevent pneumonia; and teaching good nutrition for healing and excellent handwashing. The actual test depends on the surgeon’s suturing and excising techniques to prevent leakage. This study did not provide strong evidence for the use of CGIs to prevent SSIs.

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