Abstract
Background:
Surgical site infections (SSIs) are the most common nosocomial infections suffered by surgical patients. They increase medical costs and prolong hospital stay. With respect to gastrointestinal surgery, SSIs are reported to have an incidence of up to 30%, and they frequently cause morbidity. The aim of this study was to prospectively investigate whether use of triclosan-coated sutures for abdominal incision closure during colorectal surgery reduces the incidence of SSI.
Patients and Methods:
This was a double-blinded randomized controlled trial in a single academic surgical hospital. Patients who underwent laparoscopic or open colorectal surgery were included. Patients were pre-operatively randomly assigned to either the Vicryl® Plus (VP) or Vicryl® (Ethicon Inc., Somerville, NJ) group. The patients and medical staff were blinded.
Results:
The primary end point was overall SSI rate and SSI at 30 days. Over a six-year period, 811 patients who underwent colorectal surgery and provided informed consent were randomly assigned (VP group, 396 patients; Vicryl group, 415 patients). No differences in baseline demographics were observed between the groups. The overall incidence of SSI was 4.8% (39/811 patients). There were no statistically significant differences in mean length of post-operative hospital stay between the groups (VP group, 9.3 days; Vicryl group, 9.6 days; p = 0.587). Statistically significant differences in SSI rate after post-operative day 30 were observed between the groups (VP group, 1 patient [7.1%]; Vicryl group, 7 patients [28.0%]; p = 0.039).
Conclusions:
Although use of triclosan-coated sutures did not reduce incidence of SSI within 30 days post-operatively, it is associated with reduced SSI rate after post-operative day 30.
Surgical site infections (SSIs) are a major cause of prolonged illness and a cause of death in surgical patients. With an estimated 27 million surgical procedures performed each year in the United States and an SSI rate of 2% to 5%, it is predicted that 300,000 to 500,000 cases of SSI occur annually. 1 Surgical procedures are believed to increase the risk of mortality two- to 11-fold, with 77% of the deaths directly attributed to SSIs. 2
Surgical site infections are the most common nosocomial infections in surgical patients, and they increase medical costs and prolong hospital stay. With respect to gastrointestinal surgery, SSIs are reported to have an incidence of up to 30%, and they frequently cause morbidity. 3 One cause of incision infection that has been reported in surgical literature for many years is microbial adherence to the surface of suture material. 4 In recent years, triclosan-coated polyglactin sutures with antimicrobial activity were developed to prevent microbial colonization of suture material in surgical sites. 5 It has been reported in several clinical studies that the use of triclosan-coated polyglactin sutures reduces the incidence of SSI after various surgeries.1,6,7 Triclosan-coated sutures are commercially available and have been clinically tested in different surgical procedures with diverging results.8,9 One randomized controlled trial that compared the use of triclosan-coated sutures with the use of identical sutures without triclosan coating in patients who underwent coronary artery bypass graft surgery did not report a difference in the incidence of leg-wound SSI. Nakamura et al. 1 reported that triclosan-coated polyglactin sutures reduced the incidence of SSI and the cost of gastrointestinal surgery.
The overall incidence of SSI in Korea is 2.0% to 9.7%. 10 The wide range may be due to differences in the types of surgical procedures evaluated or the risk factor levels of the patients included in the studies. 10 To date, no single-center study has investigated the effect of suture materials used during colorectal surgery on the incidence of SSI. The impact of SSI with different suture materials on hospital cost or patient satisfaction has not been studied extensively worldwide or in Korea.
An innovative therapeutic strategy to reduce the incidence of SSI is of utmost importance to enhance patient satisfaction and reduce the length of hospital stay for patients who undergo colorectal surgery. The aim of this prospective double-blinded study was to compare triclosan-coated sutures and identical sutures without triclosan coating to determine whether the triclosan-coated sutures can reduce the overall rate of SSI and the length of hospital stay.
Patients and Methods
Sample size calculation
Preliminary enrollment lasted for one year (the expected number of enrollees in each group was 130). During the preliminary enrollment, the assumed SSI rates were 5% and 10% for the study group and control group, respectively, and the sample size calculation was performed accordingly.
We assumed SSI rates were 10% in the control group and would drop to 5% in the study group. With a two-sided α of 0.05, the study was expected to have 80% power to detect a relative-risk reduction of 5%. A 10% attrition rate was assumed, resulting in an accrual goal of 400 patients in each group.
Inclusion criteria and randomization
Patients who met all the following criteria were considered for enrollment into the study: age ≥20 years; pre-documented abdominal computed tomography (CT) or magnetic resonance imaging or positron emission tomography-CT; no prior history of surgery; Eastern Cooperative Oncology Group performance status of 0–2; adequate hepatic, renal, and cardiac functions; provision of signed written informed consent; and scheduled elective colorectal cancer surgery. The exclusion criteria were as follows: objection to the use of absorbable sutures; medical condition contraindicated to surgery; and history of gastrointestinal or pelvic chemotherapy or radiotherapy within six months of study initiation.
The patients were randomly assigned according to the type of suture used for incision closure, which were triclosan-coated polyglactin 910 antimicrobial sutures (Vicryl® Plus; Ethicon Inc., Somerville, NJ) or identical polyglactin 910 sutures without triclosan coating and from the same manufacturer (Vicryl®; Ethicon Inc). Patients whose incisions were closed intra-operatively with Vicryl Plus sutures were classified in the Vicryl Plus (VP) group, and patients whose incisions were closed intra-operatively with Vicryl sutures were classified in the Vicryl group.
The randomization sequence was performed with sealed envelopes. A research nurse who was not involved in patient follow-up managed the randomization envelopes and delivered the sutures to the operating room. The coated and non-coated sutures were taken from their packages and put on the assist table with no identifying marks before the operating surgeons arrived at the operating room.
Intravenous antibiotic prophylaxis (a cephalosporin) was administered to all patients 30 minutes before incision. Incision protectors were used during open surgery and laparoscopic surgery. Standard layer-by-layer continuous suturing with or without interrupted sutures was performed on each patient.
All the clinical data were collected prospectively and approved by the clinical research ethics committee of Gachon University, Gil Medical Center. Written informed consent was obtained from all patients in accordance with the policies of the committee (identifier: GDIRB2014-01) and registered at Clinical Research Information Service (CRIS; CRIS identifier: KCT0006009). Any information that can identify patients was not included in this article. All protocols were performed in accordance with the Helsinki guidelines and regulations. All patient data were analyzed as intention to treat.
Abdominal wall closure
Chlorhexidine-isopropyl alcohol preparations were used in all patients prior to skin incision. The target pre-prandial blood glucose between 100 and 140 mg/dL and random blood glucose between 100 and 180 mg/dL was used to control the peri-operative glucose control.
The skin was incised with an N 20 blade scalpel; all other layers were transected with diathermy. Intravenous antibiotic prophylaxis (a second-generation cephalosporin) was administered to all patients 45 to 30 minutes before skin incision; the dose was repeated after five hours of operative time. The peritoneum and abdominal fascia were closed separately using the continuous suture technique with standard Vicryl or VP sutures, and the skin incision was closed with surgical staples.
Bowel preparation was performed with Colyte solution as indicated, and normothermia was maintained throughout the procedure. Intra-operative and peri-operative temperature data were obtained from the anesthesia and nursing records.
Follow-up
All incisions were inspected on post-operative days three, seven, and 30 by specially trained research nurses and evaluated according to the ASEPSIS score and the U.S. Centers for Disease Control and Prevention definition of SSI. 11 On post-operative days seven, 30, and 90, the patients were interviewed at the outpatient clinic by the same research nurses, and the nurses documented the ASEPSIS scores and the National Nosocomial Infections Surveillance (NNIS) risk scores. The research nurses involved in the follow-up of patients were blinded to group allocation. Patients who reported incision healing problems such as dehiscence, swelling, redness, or exudate were attended to at the outpatient clinic; the incisions were evaluated, and patient records were collected. Bacterial cultures were collected only from patients with symptoms of infection; in other words, surveillance cultures were not collected.
Enrollment
A total of 845 patients who underwent elective colorectal operations in the Department of Surgery, Gil Medical Center in Incheon, Korea was screened. Patients were enrolled between March 2014 and March 2020. The sample size of 845 patients were enrolled with attrition.
We excluded 34 patients from the study before randomization due to the absence of informed consent (Fig. 1). A total of 811 patients (396 patients in the VP group and 415 patients in the Vicryl group) were included in this study.

Consolidated Standards of Reporting Trials (CONSORT) diagram.
Statistical analysis
Sample size was calculated using two-proportions power analysis. Differences in continuous variables between the groups were analyzed using Student t-test, and differences in categorical variables between the groups were analyzed using χ 2 test. The provided p values are two-sided, and statistical significance was set at p < 0.05. The primary end point was SSI rate within 30 post-operative days.
Results
Comparison of patient demographics
The patient demographics of both groups are shown in Table 1. No statistically significant differences in age, gender, body mass index, American Society of Anesthesiologists class, and operation time were observed between the two groups. All the wounds were classified as clean-contaminated wounds. There were no statistically significant differences in the percentages of patients who underwent open surgery versus patients who underwent laparoscopic surgery between the groups (p = 0.873; Table 1).
Demographic Data of Patients (n = 811)
BMI = body mass index; ASA, American Society of Anesthesiologists; SD = standard deviation;
N/A, not applicable.
Incidence of SSI and length of post-operative hospital stay
Of the 811 patients included in this study, 39 (VP group, 14 patients [3.5%]; Vicryl group, 25 patients [6.0%]; p = 0.098) developed SSI; thus, the overall incidence of SSI was 4.8%. There were no statistically significant differences in mean length of post-operative hospital stay between the two groups (VP group, 9.3 days; Vicryl group, 9.6 days; p = 0.587). Similarly, there were no statistically significant differences in NNIS risk score between the two groups (VP group, 0.15; Vicryl group, 0.17; p = 0.466; Table 2).
Incidence of Incision Infection and Length of Post-Operative Hospital Stay (≤30 Post-Operative Days)
Median (range).
Mean ± standard deviation.
NNIS = National Nosocomial Infections Surveillance.
Seventeen patients in the Vicryl group and 15 patients in the VP group had superficial SSI. There were no statistically significant differences. Two patients in the VP group and three patients in the Vicryl group had deep incisional SSI. There were no statistically significant differences in the incidence of organ/space SSI and length of post-operative hospital stay between the groups. Table 3 shows the comparison of SSI rate according to post-operative period between the groups. Nine patients (23.1%) and 21 patients (53.8%) had SSI within the first three and seven post-operative days, respectively.
Comparison of Incidence of Surgical Site Infection by Period
After post-operative day 30, one patient (7.1%) in the VP group had organ/space SSI. In contrast, seven patients (28.0%) in the Vicryl group had SSI after post-operative day 30, and two of the seven patients had organ/space SSI. The difference in SSI rate between the two groups was statistically significant (p = 0.039).
The SSI rate in the laparoscopic surgery cohort was lower than that in the open surgery cohort (3.9% [25 patients] vs. 7.9% [14 patients]; p = 0.057). Compared with open surgery, laparoscopic surgery was not found to reduce SSI rate. However, the risk of SSI was lower after laparoscopic surgery than after open surgery (Table 4). In the laparoscopic surgery cohort, SSI rate was lower in the VP group than in the Vicryl group (3.2% vs. 4.6%; p = 0.360). Similarly, in the open surgery cohort, SSI rate was lower in the VP group than in the Vicryl group (4.7% vs. 9.9%; p = 0.189). Normothermia was obtained in 89% of all patients enrolled.
Laparoscopic and Open Approach (≤30 Post-Operative Days)
Summary of SSIs
The most common causative agent of SSI was Enterococcus species (4/39 cases), and the second most common causative agent of SSI was Escherichia coli (2/39 cases). Other common causative agents of SSI were Staphylococcus aureus, Streptococcus anginosus, and Klebsiella pneumoniae. No differences in the causative agent of SSI were observed between the VP and Vicryl groups. Of the 39 patients with SSI, 21 (53.8%) underwent treatment with antibiotic agents (e.g., ceftriaxone and metronidazole) for at least seven days. The longest duration of antibiotic therapy was 16 days for a case of SSI with confirmed Streptococcus anginosus growth.
The incidence of SSI in laparoscopic and open surgical approaches was not affected by the type of suture material used for incision closure (Table 5). In the laparoscopic surgery cohort, the SSI rate was 3.2% in the VP group and 4.6% in the Vicryl group (p = 0.360). Regarding patients with SSI, the mean length of hospital stay was 10.9 days for patients with ASEPSIS score of <20 and 11.6 days for patients with ASEPSIS score of ≥20; there were no statistically significant differences in mean length of hospital stay between the two cohorts (p = 0.805; Table 6).
Incidence of Surgical Site Infection in Laparoscopic Surgery and Open Surgery Cohorts
ASEPSIS Score and Length of Hospital Stay in Patients with Surgical Site Infection (n = 39)
SD = standard deviation.
Discussion
In this study, the incidence of SSI was lower in the VP group than in the Vicryl group (i.e., the control group), but the difference between the groups was not statistically significant. However, our results show that the incidence of SSI 30 days after colorectal surgery was reduced when VP sutures were used for abdominal incision closure. Vicryl Plus sutures have been used worldwide since 2003, and their effectiveness in reducing the risk of SSI has been demonstrated in general surgery and thoracic surgery.1,7 However, no study has reported a 30- to 90-day follow-up or evaluated the importance of SSI within 30 post-operative days. To the best of our knowledge, this double-blinded prospective trial is the first study to investigate the effect of triclosan-coated sutures used for abdominal incision closure 30 days after surgery.
Triclosan is an antibacterial agent shown to reduce the in vitro bacterial load of gram-positive bacteria such as Staphylococcus aureus and coagulase-negative staphylococci as well as gram-negative bacteria such as Pseudomonas aeruginosa and Escherichia coli.12,13 Several meta-analyses have reported that use of triclosan-coated sutures may prevent SSI.2,14,15 Vicryl sutures decrease tension over time and are fully absorbed after approximately two months. 16 However, because Vicryl sutures remain in the body for more than 30 days, antibiotic coating is considered necessary. We believe that the use of triclosan-coated Vicryl sutures led to a decrease in SSI rate 30 days after surgery. It is noteworthy that only one patient in the VP group had SSI 30 days after surgery.
In total, over the first 90 post-operative days, 14 of 396 patients (3.5%) in the VP group and 25 of 415 patients (6.0%) in the Vicryl (control) group developed SSI. There were no differences in the incidence of incisional SSI between the groups (p = 0.098). This finding may have been due to the low SSI rate and the comparable lengths of post-operative hospital stay between the groups. Thus, SSI may have gone unnoticed in patients who were discharged within seven days after surgery; these patients presented with SSI within 30 days after surgery. It is interesting to note that extended-spectrum β-lactamase-producing Escherichia coli was the causative agent of organ/space SSI in all three patients with organ/space SSI. Two of the three patients underwent percutaneous catheter drainage. Superficial SSIs are more common than deep-space or organ/space SSIs, and they generally require less aggressive treatment than deep-space or organ/space SSIs. Organ/space SSIs often require invasive management with long-term intravenous antibiotic therapy, percutaneous drainage procedures, and re-operations. The results of this study clearly show the effectiveness of triclosan-coated polyglactin antimicrobial sutures in colorectal surgery.
Although triclosan-coated sutures are expensive, they can be considered cost effective in terms of the long-term follow-up of patients because the incidence of SSI within 30 days after surgery in patients whose incisions were closed with triclosan-coated sutures is low.
Several studies have reported that the incidence of SSI after colorectal surgery is lower with the laparoscopic approach than with the open approach.17–21 Although this study was underpowered, the data obtained in this study did not show that the laparoscopic approach is associated with low SSI rate compared with the open approach. Although two trials reported a lower incidence of SSI after laparoscopic surgery than after open surgery, 10 other trials did not report a difference in the incidence of SSI between the laparoscopic and open surgical approaches. The results of this study showed that the laparoscopic approach did not affect SSI rate.
This study has some limitations. One limitation of this study is that it is a single-center study conducted over a six-year period. Another limitation of this study is the possibility of unknown confounding factors such as general anesthesia techniques, normothermia, changes in diet during hospital stay, and other social determinants.
Conclusions
The overall incidence of SSI in this study was 4.8%. The SSI rate was 3.5% in the VP group and 6.0% in the Vicryl group, but no statistically significant differences in SSI rate were observed between the two groups. The incidence of SSI after post-operative day 30 was lower in the VP group than in the Vicryl group, but without statistical significance. At 90 days, there were no significant differences in the incidence of incisional SSI between the groups. It is necessary to conduct larger multicenter studies to obtain more evidence.
Footnotes
Authors' Contributions
Study concept and design: Lee. Acquisition of data: Lee, Kang. Analysis and interpretation: Choi, Kang, Lee. Study supervision: Lee.
Funding Information
This work was supported by the National Research Foundation of Korea (NRF) grant funded by the Korea government (MSIT) (No. NRF-2021R1A5A2030333).
Author Disclosure Statement
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
