Effect of Gentamicin-Containing Collagen Sponges on Surgical Site Infection after Hand-Assisted Laparoscopic Donor Nephrectomy

Abstract

Background:

Postoperative surgical site infection (SSI) can be considered a frequent complication of hand-assisted laparoscopic donor nephrectomy (HALDN). Since 2007, our center used routinely a gentamicin-containing collagen sponge (GCCS) when closing the wound. The effect of GCCS on SSI is not elucidated clearly. In this retrospective cohort study, we assessed the effects of GCCS on SSI after HALDN.

Methods:

Between December 2004 and November 2007, we treated 100 patients without GCCS, and from November 2007 to July 2010, there were 100 patients with GCCS placed after HALDN. A SSI was defined as an incisional infection that required an intervention such as opening of the site or antibiotic treatment within 90 days after surgery.

Results:

Implantation of a GCCS resulted in a statistically significant reduction in the SSI rate, from 6% to 0 (p=0.01). All infections occurred in the Pfannenstiel incision site. There was no significant difference between the groups in the creatinine concentration after three months.

Conclusions:

The use of gentamicin-containing collagen sponges reduces the risk of SSI significantly after HALDN without compromising kidney function.

Living donor renal transplantation has increased over the last years, as it provides better patient and graft survival than organs from deceased donors. The introduction of the hand-assisted laparoscopic donor nephrectomy (HALDN) technique has decreased donor morbidity substantially compared with the open technique [1,2]. Additionally, HALDN results in a shorter operating time, less blood loss, fewer conversions to open nephrectomy, and a shorter warm ischemia time than total laparoscopic donor nephrectomy while maintaining low morbidity and a short hospital stay [1,2].

Postoperative surgical site infections (SSI) are a common complication after donor nephrectomy. Such an infection increases the duration of hospital stay, the postoperative recovery period, the risk of wound dehiscence, and cost [3]. Furthermore, as the donors undergo an operation without personal benefit, it is even more important to minimize the risks of complications after kidney donation. With the serious medical and psychological implications of post-operative infection in healthy kidney donors, it is imperative that measures, including the use of prophylactic antibiotics, be taken to prevent infection.

To reduce the likelihood of SSI after HALDN, our center now applies gentamicin-containing collagen sponges (GCCS) routinely when closing the incision. However, the effect of GCCS on SSI has not been elucidated clearly, and the reported results from various studies are inconsistent [4 –8]. In this study, we assessed retrospectively the effect of GCCS on the incidence of SSI after HALDN.

Patients and Methods

In November 2007, we started routine insertion of a GCCS during HALDN. We compared 100 consecutive donors with a GCCS placed routinely (November 2007–July 2010) with the 100 consecutive donors seen before this period (December 2004–November 2007) when no GCCS was used. All procedures were done at the Academic Medical Center, Amsterdam.

Preoperatively, the surgical field was treated with iodine directly after the pubic hair was removed on the table by electric hair clippers. No systemic antibiotic prophylaxis was given. The surgical team members washed their hands with chlorhexidine soap, and an alcohol hand solution was applied. The HALDN was carried out transperitoneally. One surgeon (MMI) performed all procedures. Before the start of the study period, the surgeon had a personal experience of 70 HALDNs. The hand port (Omniport, Advanced Surgical Concepts, Wicklow, Ireland) was placed in a 7–8-cm long Pfannenstiel incision, the length of which was standardized to the width of the surgeon's left hand (glove size 7). The non-dominant hand of the surgeon was introduced through the hand port in all operations. Two trocars were placed, one of 10 mm for the videoscope, and one of 12 mm for the ultrasonic dissection device (Ultracision) in the surgeon's dominant hand. A maximum insufflation pressure of 12 mm Hg was used. The kidney was extracted through the hand port.

During closure of the incision in the more recent 100 cases, one GCCS (EUSA Pharma Ltd, Oxford, UK) was placed. This sponge is made of pepsin-treated collagen, measures 10×10×0.5 cm, and contains 130 mg of gentamicin. The sponges were divided in three pieces. The first piece was placed pre-peritoneally behind the rectus abdominis muscles, the second between the rectus abdominis muscles and the anterior rectus sheath, and the third subcutaneously. No drains were placed. The subcutis was closed such as to obliterate dead space. The skin was closed intracutaneously, and a dry dressing was applied. The operation technique and environment were identical throughout the study, as was the anesthesiology protocol (volume administration and body temperature regulation methods) was identical. No patients in either group needed a peri-operative red blood cell concentrate transfusion, and no open conversions were required.

A superficial incisional SSI was defined as an infection that required an intervention such as opening of the incision or antibiotic treatment within 90 after surgery. A deep incisional infection was defined as an infection of abdominal wall muscle or fascia. Furthermore, we assessed the length of the postoperative hospital stay and the serum creatinine concentration three months after surgery. No donors were lost to follow-up, and the mean follow-up was 2.70 yrs.

The χ² test was used to compare discrete data between groups. Comparison of continuous variables was performed with the Mann-Whitney U test. A p value of<0.05 was considered statistically significant. Statistical analyses were performed using SPSS v. 16 for Windows (SPSS, Chicago, IL).

Results

The study groups were similar with regard to baseline characteristics (Table 1). Implantation of a GCCS resulted in a statistically significant reduction of the SSI rate, from 6% to 0 (p=0.01; see Table 2). All infections occurred in the Pfannenstiel incision, and all were opened (partially). In the cultures, we found Staphylococcus aureus in two patients, Pseudomonas aeruginosa in one patient, Streptococcus milleri in one patient, and no microorganisms in the remaining two patients.

Table 1.

Baseline Characteristics of Donors

	No GCCS (n=100)	GCCS (n=100)	p value
Female sex	59	56	0.62^a
Mean age±SD (years)	47.6±12.9	49.8±11.7	0.42^b
Mean body mass index±SD (kg/m²)	25.6±3.4	24.8±3.1	0.17^b
Smoker	15	24	0.57^a
Hypertension	23	31	0.51^a
Duration of surgery±SD (min)	182±40	163±36	0.68^b

χ² test.

Mann-Whitney U test.

GCCS=gentamicin-containing collagen sponge; SD=standard deviation.

Table 2.

Postoperative Outcomes

	No GCCS (n=100)	GCCS (n=100)	p value
Site infections	6	0	0.01^a
Other complications	5	4	0.75^a
Overall complications	11	4	0.07^a
Median hospital stay (days) (IQR)	4.0 (4.0–5.0)	4.0 (3.0–5.0)	0.36^b
Mean creatinine concentration after three months±SD (mg/dL)	1.18±0.22	1.19±0.24	0.68^b

χ² test.

Mann-Whitney U test.

GCCS=gentamicin-containing collagen sponge; IQR=interquartile range; SD=standard deviation.

No deep incisional SSIs occurred. Two persons with SSI developed an incisional hernia. In addition, we found nine other complications, of which five were in the non-GCCS group (5% of the total) and four in the GCCS group (4%; odds ratio [OR] 0.80; 95% confidence interval [CI] 0.21–3.07). These complications were four cases of pneumonia, one ileus, one iatrogenic gallbladder perforation with leakage, one leakage of chyle, one ventral hematoma, and one case of atrial fibrillation. There was no significant difference in the duration of surgery in the two groups (p=0.68), and the postoperative hospital stay was similar (p=0.36). The mean postoperative serum creatinine concentrations after three months were 1.18±0.22 mg/dL (standard deviation) in the group without GCCS and 1.19±0.24 mg/dL in the group with GCCS (p=0.68).

Discussion

Application of a GCCS during HALDN results in significantly fewer postoperative SSIs. Since the introduction of GCCS during HALDN in our center, not one SSI occurred in 100 consecutive HALDN procedures. The 6% SSI rate in the group without a GCCS is similar to that in other studies, where incidence rates between 2.6% and 7.5% have been described [9,10]. In a study by Zomorrodi and Buhluli, an SSI rate of 2%–4% was reported after donor nephrectomy with systemic antibiotic prophylaxis [11].

The use of systemic antibiotic prophylaxis in (donor) nephrectomy is a subject of discussion. Nephrectomies are clean-contaminated procedures, because they cross a presumably uninfected genitourinary tract. However, some authors advocate routine systemic antibiotic prophylaxis [12]. We did not use preoperative systemic prophylactic antibiotics, because earlier studies demonstrated that there was no beneficial effect on SSI, especially in clean laparoscopic surgery in low-risk (American Society of Anesthesiologists class I) patients [13,14]. Previous studies in patients undergoing abdominal surgery for rectal cancer found a reduction of SSI with application of a GCCS [4,5]. In addition, one study found a significant reduction of overall postoperative complications when a GCCS was used [5]. A more recent study, by Schimmer et al., found that GCCS significantly reduced the incidence of SSI [6]. However, two studies from Bennett-Guerrero et al. found no effect of GCCS in patients undergoing cardiac surgery and a significant increase in SSI with the use of GCCS in colorectal surgery [7,8]. Those authors hypothesized that this effect may be the result of selection of more resistant bacteria, a loss of effectiveness secondary to rapid elution of the gentamicin, or a mechanical barrier effect of collagen, delaying effective closure of the incision.

In our study, we found no evidence of nephrotoxicity, as there was no significant difference in creatinine concentrations between the GCCS group and the non-GCCS group. Swieringa et al. demonstrated that application of one GCCS with 130 mg gentamicin does not result in a toxic serum gentamicin concentration [15]. The advantage of GCCS is a locally high concentration of antibiotics in the surgical area, avoiding a high systemic concentration that can be associated with nephrotoxicity. In the pharmacokinetic study of Jørgensen et al., the local gentamicin concentration of one collagen sponge containing 130 mg of gentamicin exceeded the minimum inhibitory concentration (MIC) for most bacteria normally considered resistant to gentamicin [16]. These high MIC values were sustained for two to three days. These findings diminish the predictive value of the regular in-vitro testing and contradict the hypothesis of rapid elution of gentamicin.

The use of a handport in the abdominal wall causes high tension on the skin around the surgical site and might result in poor microperfusion of the peri-incision skin during the procedure. Consequently, this area is possibly more susceptible to infection by ordinary microorganisms such as S. aureus. Cavanaugh et al. demonstrated in an experimental study that GCCS was more effective than systemic antibiotic treatment in decreasing the local number of colony-forming units of S. aureus [17]. These findings, combined with the hypothetical negative effect of the handport on the local incision conditions in an otherwise-sterile operation, were the basis of starting the use of the GCCS in our hospital. However, previous studies failed to demonstrate a higher risk of SSI after HALDN compared with a non-hand-assisted laparoscopic donor nephrectomy.

A limitation of our study is that no randomization was performed, the analyses being done in two consecutive groups. This could have induced bias secondary to a cohort effect. There is a possibility that the sequential design of the study has been a confounder. However, we assumed that this was unlikely, because the operating surgeon had a personal experience of 70 procedures before starting the study and therefore probably had completed the learning curve.

In conclusion, we found a clear benefit of the use of one 130-mg GCCS in HALDN. It reduced the risk of postoperative SSI and therefore lowered postoperative morbidity. Routine application of a GCCS in HALDN is a safe procedure that does not compromise kidney function.

Footnotes

Author Disclosure Statement

No competing financial interests exist.

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