|Year : 2020 | Volume
| Issue : 2 | Page : 79-84
An economic model to assess the value of triclosan-coated sutures in reducing the risk of surgical-site infection in coronary artery bypass graft in India
Nilesh Mahajan1, Reshmi Pillai1, Hitesh Chopra2, Ajay Grover2, Ashish Kohli2
1 Medical Affairs, Clinical Operations and Device Safety, Johnson and Johnson Pvt. Ltd, Mumbai, Maharashtra, India
2 Ethicon Sales and Marketing team, Johnson and Johnson Pvt. Ltd, Mumbai, Maharashtra, India
|Date of Submission||23-May-2020|
|Date of Acceptance||12-Jul-2020|
|Date of Web Publication||25-Sep-2020|
Dr. Nilesh Mahajan
Johnson and Johnson Private Limited, 501 Arena Space, Off Jogeshwari - Vikroli Link Road, Jogeshwari (East), Mumbai, Maharashtra
Source of Support: None, Conflict of Interest: None
Background: The incidence of surgical site infections (SSIs) is higher in India compared to the rest of the world. In patients undergoing coronary artery bypass graft (CABG), the risk is even higher. SSI following CABG is associated with an additional length of stay (LOS) resulting in additional costs, thus causing a significant economic burden on patients and society. We aimed to determine the additional costs and LOS due to SSIs after CABG and to evaluate the efficacy of triclosan-coated sutures (TCS) in reducing the SSI rate. Methodology: A systematic literature search of available evidence for both epidemiologic and economic data related to the incidence of SSI (from 1998 to 2018) and efficacy of TCS (from 2000 to 2018) respectively, were gathered. We compared 100 surgeries from private and public hospitals for CABG and calculated cost-effectiveness of TCS in comparison to conventional nonantimicrobial-coated sutures (NCS) using a decision-tree cost model. Results: Three studies were analyzed out of 109 citations for the analysis of SSI incidence and for the efficacy of TCS versus NCS, five studies were included. We performed a one-way sensitivity analysis to calculate the impact of efficacy (%) and SSI incidences (%) and cost of NCS and TCS on cost savings depicted by Tornado charts. Sensitivity analysis on the comparison of TCS with NCS, a base cost saving of CABG for a private hospital was INR 14,476 and public hospital INR 4145. Conclusion: The use of TCS reduced SSI incidence and cost savings for CABG surgeries in both public and private sectors in India.
Keywords: Coronary artery bypass graft, nonantimicrobial coated suture, surgical site infection, triclosan-coated suture
|How to cite this article:|
Mahajan N, Pillai R, Chopra H, Grover A, Kohli A. An economic model to assess the value of triclosan-coated sutures in reducing the risk of surgical-site infection in coronary artery bypass graft in India. J Indian coll cardiol 2020;10:79-84
|How to cite this URL:|
Mahajan N, Pillai R, Chopra H, Grover A, Kohli A. An economic model to assess the value of triclosan-coated sutures in reducing the risk of surgical-site infection in coronary artery bypass graft in India. J Indian coll cardiol [serial online] 2020 [cited 2020 Oct 27];10:79-84. Available from: https://www.joicc.org/text.asp?2020/10/2/79/296122
| Introduction|| |
Surgical site infection (SSI) is a commonly occurring nosocomial infection that leads to significant morbidity with intermittent mortality, thereby increasing health-care cost. Sternal wound infections are the most costly SSI owing to the complications such as sternal dehiscence and the organ/space SSI in the form of mediastinitis, occurring due to infections following coronary artery bypass (CAB) surgery. Crude rates of complex sternal site infections after CAB graft (CABG) increased over the reporting period, ranging from 0.7% in 2004%–2.6% in 2011. Cannon et al. identified that the ratio of SSI to all health-care-related infections is 1:4 in children undergoing cardiac surgery and the incidence of SSI in them is 1.4%–6.3%.
Hollenbeak et al. found that patients with deep chest SSI following CABG face poorer clinical consequences than patients without deep chest SSIs. Patients with deep chest SSIs were found to have a 21% higher mortality rate, 20-day additional hospital stay, and $20,012 (USD) additional cost in comparison to patients without deep chest SSI in the 1st year after surgery. Hence, suture materials coated with an antibacterial or antimicrobial agent such as triclosan may have the potential to reduce the risk of SSIs or health-care-associated infections. A study by Thimour-Bergström has shown that triclosan-coated sutures (TCS) or triclosan-impregnated sutures in CABG patients can efficiently reduce SSIs.,
Triclosan is a broad-spectrum antibacterial agent widely used owing to its prompt, tenacious, broad-spectrum antimicrobial use and utility in health-care-related infections. It is active against both Gram-positive and Gram-negative bacteria.
The WHO Guidelines (2016) have recommended the use of TCS irrespective of the type of surgery. This study presents the incidences of SSI and the efficacy and cost-effectiveness of antibacterial-coated suture, triclosan, in reducing the incidences of SSI in CABG surgery in India.
| Methodology|| |
For economic burden analysis of SSI in India, we conducted a systematic literature review (SLR) of available evidence to gather epidemiologic and economic data pertaining to the occurrence of SSI from 1998 to 2018 in India [Figure 1] and from 2000 to 2018 for TCS versus nonantimicrobial-coated sutures (NCS) [Figure 2]. Evidence was gathered from randomized controlled trials and comparative cohort studies and high-quality systemic review.
|Figure 1: PRISMA flow chart for the review of incidence of surgical site infections|
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|Figure 2: PRISMA flow chart for the review of efficacy of triclosan-coated sutures|
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PubMed Medline and EMBASE indexed articles were searched using Mesh terms or Emtree, respectively, and free test terms such as SSIs, the incidence of SSI, TCS, NCS, and CABG. Full papers were retrieved from accepted articles. Manual checking of references for relevant review articles was performed.
We also conducted a cost study to assess costs associated with SSI. We determined the cost associated with treating patients with SSI and without SSI by obtaining and calculating the cost information from two tertiary care hospitals (private and public hospitals) in India.
We collected the data for the average number of postoperative hospital stay in cases of SSI, cost of hospital stay per day, surgical bundle cost, the unit cost of antibiotic treatment, number of days of antibiotic treatment, the unit cost of incision and drainage procedure for SSI management, the average cost of pathological tests, number of pathological tests required in cases of SSI-management, average physician and nursing staff costs, number of visits by physician and nursing staff for cases with SSI, and unit cost of sutures to calculate the costs of treatment of patients developing SSI and without SSI.
The SSI incidence data were combined with cost data to calculate the extra cost due to SSI. The cost difference in public and private hospital settings was calculated by combining the SSI incidence (%) with total costs incurred in patients with and without SSI. This helped us with the calculation of extra cost due to SSI/100 surgeries performed that were specific to private and public hospital settings in India.
In the TCS/NCS efficacy study, decision tree analysis was used to compare the costs of using TCS and NCS in surgical procedures. The decision tree analysis is the most widely used model which provides a framework for the calculation of the expected value of each available alternative [Figure 3]. In this study, SSI incidence expressed as the proportion of patients developing SSI by the total number of patients was determined from SLR for the TCS and NCS group across different types of surgery and depending on the surgery category. Cost data for treating patients with and without SSI were calculated from the cost study. These costs were assigned as a payoff to different branches of the decision tree that enabled calculation of total costs associated with the use of TCS and NCS. Sensitivity analysis was performed to check the quality and reliability of the given model and its prediction provides an understanding of how model variables react to input changes. In this study, the key inputs considered are probability for developing SSI (or SSI risk), the efficacy of TCS, and cost of sutures. Assumptions were made based on decision tree models such as the cost of TCS and NCS was the same in private and public hospitals and the maximum retail price (MRP) was used for each suture, SSI incidences were assumed the same for private and public hospitals, the efficacy of TCS was obtained from literature studies of the surgical specialty, and SSI incidences from literature sources for each surgical procedure represented the SSI incidences for the NCS arm of the decision tree model.
| Results|| |
A total of 109 citations were screened manually for SSI and studies that do not include rates of SSI were excluded. After the final review, three studies were included for the analysis of SSI and five for TCS versus NCS efficacy.
Two of three studies were prospective and one study was retrospective [Table 1]. The total number of patients included for SSI analysis was 8736 [Table 1]. For TCS versus NCS efficacy, five studies were available [Table 2]. The total number of patients (n = 8736) was included in the TCS versus NCS efficacy study. These studies compared polyglactin 910 suture without triclosan coat (VICRYL) versus polyglactin 910 suture with triclosan coat (VICRYL Plus). Of eight studies, five studies followed CDC guidelines of wound infection. Wound infection guidelines were not available for two studies, and for one study, it is unknown whether they followed wound infection guidelines.
|Table 1: Studies included in surgical site infections incidence analysis and for triclosan-coated sutures versus nonantimicrobial-coated sutures efficacy analysis|
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|Table 2: Costs savings (in INR) per 100 surgeries for varied efficacies of triclosan-coated sutures to prevent surgical-site infections and risk of developing surgical site infections among coronary artery bypass graft surgeries in private hospital and public hospitals|
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The characteristics of studies that were screened and selected for this study are mentioned in [Table 1].
SSI incidences and TCS' efficacy were calculated from the following Indian studies for CABG [Table 1].
Surgical site infection and efficacy rate analysis
We calculated the SSI incidence rate from Indian studies for cardiovascular studies. SSI incidence was found to be 1.6%, 4.3%, and 18.86% at low, median, and high levels, respectively. TCS efficacy rates were also calculated from the five studies mentioned above. They were as follows: (n = 5): lower end (4%), median (38%), and the upper end (100%).
Cost data were obtained for CABG from both private and public hospitals.
Patients who developed SSI had extended hospital stay and received additional medical and surgical care leading to an increase in cost. SSI management included intravenous antibiotics, pathology cost, wound care, and surgical procedure for SSI management if any. Total SSI cost included SSI management, additional hospitalization cost, and cost of each admission loss due to bed occupancy, called as an opportunity cost for this study.
For cost-saving analysis, the total cost for treating a patient developing SSI was calculated as the sum of the surgical package cost (minus the cost of NCS), opportunity cost, and SSI management cost. The total cost of SSI (per 100 surgeries) was multiplied by the SSI incidence rate for the TCS and NCS groups and the difference in total costs was expressed as a percentage of the total cost of NCS group. In private hospitals, by using TCS in CABG surgery, the cost saving is 31.98%, and in public hospitals, by using TCS, the cost saving is 23.02%.
Decision tree analysis using the model presented in [Figure 3] was used to calculate the costs associated with the use of TCS and NCS. The difference in total costs for each suture type was represented as the model output.
For CABG surgeries with TCS at a private hospital, at risk of SSI (1.6%, 4.3%, and 100%), cost savings were observed at all efficacy values. Cost savings increased with an increase in SSI incidence and an increase in efficacy [Table 2].
For CABG surgeries with TCS at a public hospital, at risk of SSI (1.6%) and efficacy (4%), the additional cost was observed. In contrast, at risk of SSI (38% and 100%), cost savings were observed at all efficacy values. Cost savings increased with an increase in SSI incidence and an increase in efficacy [Table 2].
We calculated the incremental cost of TCS suture (cost of TCS−cost of NCS)/surgical package cost × 100) for CABG surgery. In private hospital, it was 0.05%, whereas in public hospital, it was 0.16%. The cost savings (%) generated using TCS was greater than the incremental cost increase across all SSI incidences and TCS efficacy rates in private hospital and at the median and high SSI incidences and efficacy rates for public hospital.
Tornado plots for CABG [Figure 4] and [Figure 5] show the impact of four variables: efficacy (%), SSI incidences (%), cost of NCS (±20%), and cost of TCS (±20%) on cost saving on CABG procedure in private and public hospitals. The base value of cost savings for CABG surgery for the private hospital is INR 14,476 and the public hospital is INR 4145. SSI incidence had the greatest impact on total cost saving. However, the literature study did not differentiate wound type as clean, clean–contaminated, contaminated, and dirty with respect to SSI.
|Figure 4: Cardiovascular (coronary artery bypass graft): Private hospital, Tornado chart showing mean cost savings per surgical procedure based on model assumptions|
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|Figure 5: Cardiovascular (coronary artery bypass graft): Public hospital, Tornado chart showing mean cost savings per surgical procedure based on model assumptions|
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| Discussion|| |
This systematic review included prospective investigator-initiated randomized double-blinded single-center study,, a prospective randomized study, a cohort prospective surveillance study, a prospective study, and a retrospective study , for SSI incidence and for TCS versus non-TCS efficacy. Using TCS for surgeries having a 1.6% risk of SSI saved INR 37486.1, 1417152 depending on the efficacy of TCS. This shows that an intervention that can reduce the number of deaths, even marginally, can lead to substantial cost savings. Cost savings increased with an increase in SSI incidence and an increase in efficacy. Although TCS is almost 0.4 times expensive than NCS, the cost saving provided by preventing CABG SSIs not only counterbalances this expense but also observed to be saving cost, even when the cost saving was as low as 1.6% and efficacy of TCS in preventing SSIs was at the lowest (5%).
Singh et al. have claimed that TCS is better sutures than collagen-gentamicin sponges for cardiothoracic surgeries. According to Singh et al., TCS, when used for surgeries with 15% SSI risk, saved approximately 2–8 times the costs per SSI prevented by collagen-gentamicin.
Our findings suggest that the use of TCS to lower SSI incidence and cost saving, one needs to be careful with the use of triclosan. The chances of developing antimicrobial resistance to triclosan had observed, especially in topical products.
The cost saving by the use of TCS for CABG was 0.05% in private hospital, whereas in public hospital, the cost saving was 0.16%. A low-priced coated-suture cost can generate even more cost savings, leading to an additional savings; the cost savings per CABG surgery increased linearly with increasing efficacy and with increasing SSI incidence. Cost savings would decrease proportionately with high-priced coated sutures.
The efficacy of TCS in reducing SSI is controversial. Chang et al. have reported that the use of TCS is not beneficial, while Wang et al. reported the efficiency of TCS in reducing SSI. The potential reasons for disagreement among study results are the clinical sample size, different study designs, blindness of patients and assessors, length of follow-up, heterogeneity of surgical procedures, methods, the definition of SSI, evaluation of risk factors in the analysis, inclusion and exclusion criteria, suture material used, parameters evaluated, and unrecorded data at follow-up.
| Conclusion|| |
On the basis of our research, despite controversial results among the clinical studies, the antimicrobial suture was effective in decreasing the risk for postoperative SSIs in a broad population of patients undergoing surgery. The results from our analysis are both sensitive to the efficacy of TCS and the risk of SSI. However, additional studies needed to carry out to establish the efficacy of such sutures and evaluate their benefits for surgeries with varied SSI rates.
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Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5]
[Table 1], [Table 2]