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    -  Mahajan NS
    -  Pillai R
    -  Chopra H
    -  Grover A
    -  Kohli A

 
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ORIGINAL ARTICLE
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An economic model to assess the value of triclosan-coated sutures in reducing the risk of surgical site infection in a mastectomy in India


1 Medical Affairs, Clinical Operations and Device Safety, Johnson and Johnson Pvt. Ltd, Jogeshwari (East), Mumbai, Maharashtra, India
2 Ethicon Sales and Marketing Team, Johnson and Johnson Pvt. Ltd, Jogeshwari (East), Mumbai, Maharashtra, India

Date of Submission22-Nov-2019
Date of Decision22-Nov-2019
Date of Acceptance11-Aug-2020
Date of Web Publication19-Sep-2021

Correspondence Address:
Nilesh S Mahajan,
Medical Affairs, Clinical Operations and Device Safety, Johnson and Johnson Pvt. Ltd, Jogeshwari (East), Mumbai, Maharashtra
India
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/ijc.IJC_1000_19

  Abstract 


Background: The comparison of triclosan-coated sutures (TCS) was made with conventional nonantimicrobial-coated sutures (NCS) to reduce surgical site infection (SSI). This study demonstrates the efficacy and economic outcome of TCS versus NCS for SSIs in mastectomy in India.
Methods: In this retrospective analysis, 100 patients were included for both conditions—TCS and NCS—from a private and public hospital in India. A systematic literature search of available evidence for both SSI incidences and TCS efficacy data in India were gathered. We collected cost data from a private and public hospital, respectively, for mastectomy in India. The cost-effectiveness of TCS in comparison with the conventional NCS was calculated using a decision-tree deterministic model. We performed a one-way sensitivity analysis to compare TCS with NCS.
Results: Cost savings with the use of TCS increased with an increase in SSI incidence and an increase in efficacy for mastectomies in both public and private hospitals. We found a base cost saving of Indian rupees (INR) 27,299 at a private hospital and INR 2,958 at a public hospital for mastectomies. The incremental cost of TCS suture was 0.01% in a private hospital whereas 0.17% in a public hospital.
Conclusion: The use of TCS resulted in reduced SSI incidence and cost savings for mastectomy in India.


Keywords: Cost savings, efficacy, mastectomy, non-antimicrobial-coated sutures, surgical site infection, triclosan-coated sutures
Key Message: The use of triclosan-coated sutures decreased the incidence of surgical site infections and further, generated the cost-saving.



How to cite this URL:
Mahajan NS, 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 a mastectomy in India. Indian J Cancer [Epub ahead of print] [cited 2021 Oct 27]. Available from: https://www.indianjcancer.com/preprintarticle.asp?id=326245



  Introduction Top


Triclosan is a broad-spectrum antibiotic that is active against a class of common surgical pathogens. Several studies have documented the efficacy of triclosan when impregnated with polydioxanone, polyglactin 910, and poliglecaprone 25.[1],[2] In such cases, the maximum concentration of triclosan to produce an antimicrobial effect is approximately 2.3 mg/m and 0.47 mg/m in polyglactin 910.[3],[4]

There has been evidence in the literature that the use of TCS had reduced the incidences of surgical site infections (SSIs) in comparison with conventional sutures, but it is difficult to estimate the direct attributable cost of SSI.[5],[6],[7],[8] However, a study evaluated the cost of SSI using a decision-tree model suggesting that TCS can significantly reduce the hospital stay when the infection rate was 10%.[8] The burden of SSI after mastectomy ranges from 12.5% to 25% in India.[9],[10] Poor adaption of international guidelines and pharmacological interventions.

According to the World Health Organization guidelines, TCS can be used for any type of surgery.[11] In this study, we accessed the incidences of SSI after mastectomy and efficacy and cost-effectiveness of TCS based on a decision-tree model in Indian patients.


  Methods Top


Literature search and data extraction

For both economic burden analysis of SSI in India and the efficacy of TCS versus NCS, 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 [Figure 1] and the efficacy of TCS versus NCS from 2000 to 2018 [Figure 2]. Evidence was gathered from prospective randomized controlled trials (RCT), comparative cohort studies, and high-quality systemic reviews, if available. 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, and efficacy of TCS. Search criteria were defined by the total number of patients undergoing surgery (N), the number of patients developing SSI (n), and type of healthcare institute (private and public hospital). In this study, data extracted were from Indian studies for oncologic surgery that included surgical procedures mastectomy. For all publications, the SSI or surgery wounds was recorded as defined by the Centers for Disease Control and Prevention (CDC) as clean, clean-contaminated, contaminated, and dirty.
Figure 1: PRISMA flowchart for the economic burden of surgical site infection in India

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Figure 2: PRISMA flow chart for the triclosan-coated sutures versus nonantimicrobial-coated sutures efficacy studies

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Full papers based on the scope of the study were retrieved from accepted articles. Manual checking of references for relevant articles was performed. Data extraction was conducted by one reviewer and re-examined by others.

Cost study

We also conducted a cost study to assess costs associated with SSI. The package cost of one mastectomy (private and public hospital) in Mumbai, India was determined by us. In addition, we determined the cost associated with treating patients with SSI and without SSI by obtaining and calculating cost information (refer section: cost analysis model for SSI). Further, we also calculated the difference in the cost of TCS versus NCS using a decision-tree model for the efficacy of TCS in SSI (refer section: cost analysis model for TCS versus NCS) [Figure 3].
Figure 3: The basic structure of the decision-tree cost model. In this model, antimicrobial suture or nonantimicrobial suture can be used for surgery, which could be either surgical site infection or nonsurgical site infection

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Statistical analysis

Cost analysis model

SSI



In the economic burden study, the SSI incidence (number of patients with SSI/total number of patients) undergoing surgery expressed as the median and range were calculated to determine incidence (expressed as %) of SSI. This was supported by a cost study to obtain costs associated with SSI. The cost associated with treating patients with SSI and without SSI was obtained from two tertiary care hospitals (one private and one public hospital) in Mumbai, India. In addition, the standard SSI treatment protocol for that hospital was obtained for analysis. For this analysis, the costs of treatment of patients developing SSI with those without SSI following parameters were considered, such as total cost of hospital stay for patients, the total cost of the surgical bundle (including surgeons, operation theater, anesthetists, and bed charges), the average total cost of antibiotic treatment, cost of procedures for management, pathology service costs, medical staff costs, and cost of the intervention.

The SSI incidence data were combined with cost data to calculate the extra cost because of SSI. The cost difference in public and private hospital settings was calculated by combining the SSI incidence (%) with the total costs incurred in patients with and without SSI. This helped us in calculating the extra cost because of SSI per 100 surgeries performed that were specific to private and public hospital settings in Mumbai, India.

TCS versus NCS



In the TCS/NCS efficacy study, the decision-tree analysis model was designed, as shown in [Figure 3], to compare the costs of 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. 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 oncology (mastectomy). Cost data for treating patients with and without SSI were calculated from the cost study. These costs were assigned as the 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 the probability for developing SSI (or SSI risk), the efficacy of TCS, and the cost of sutures. The calculation of cost savings using the decision-tree model was based on the following assumptions: the cost of TCS and NCS was the same in private and public hospitals and the maximum retail price was used for each suture; SSI incidences were assumed the same for private and public hospitals; efficacy of TCS was obtained from a literature study of oncology; and SSI incidences from literature sources for each surgical procedure (mastectomy) represented the SSI incidences for the NCS arm of the decision-tree model.


  Results Top


Study identification

A total of 52 citations were screened manually for SSI incidences in India, and studies that did not include rates of SSI were excluded. After the final review, five studies were included for analysis of SSI; however, for TCS versus NCS efficacy, only two global studies were included.

Included studies

Five out of six studies were prospective and one study was retrospective [Table 1]. The total number of patients included from these Indian studies for SSI analysis was 4,328 [Table 1]. For TCS versus NCS efficacy, two studies were available [Table 2].[17] The total number of patients from these two global studies, included in the TCS versus NCS efficacy analysis, was 4246. The study compared triclosan-coated polyglactin 910 antimicrobial suture (VICRYL Plus) and polyglactin 910 suture (VICRYL). Out of the six Indian studies for SSI incidence analysis, four studies followed CDC guidelines of wound infection, whereas one study followed the wound infection guidelines of Southampton wound scoring system along with CDC guidelines. In all included studies, wound infection occurring within 30 days following surgery was considered as a criterion.
Table 1: Studies included in surgical site infection incidence analysis

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Table 2: Studies screened and selected for triclosan-coated suture versus nonantimicrobial- coated suture efficacy analysis

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SSI rate analysis

We calculated the SSI incidence rate from Indian studies in patients who had undergone a mastectomy. We used SSI incidence ranges (lowest to highest) [Table 3].
Table 3: Surgical site infections incidence rate (India-specific data)

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Efficacy rate analysis

Efficacy rates of TCS were calculated in the patient who had undergone a mastectomy. The rates of the efficacy of TCS versus NCS (median and ranges) for mastectomy were used in the analysis [Table 4].
Table 4: Efficacy of triclosan-coated suture versus nonantimicrobial-coated suture (ranges) for mastectomy surgery

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Cost analysis

Cost data were obtained from patients who had undergone a mastectomy, and reoperation was done using TCS from both private and public hospitals. We have considered opportunity cost as a loss of the surgical package based on bed occupancy.

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 mastectomies with TCS at a private hospital, at risk of SSI (5.56%, 12.2%, and 25%), cost savings were observed at all efficacy values. Cost savings increased with an increase in SSI incidence and an increase in efficacy [Table 5].
Table 5: Costs savings (in INR) per surgical site infections for varied efficacies of triclosan-coated sutures to prevent surgical site infections and risk of developing surgical site infections for mastectomy surgery in private and public hospital

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We calculated the incremental cost of TCS suture (cost of TCS − cost of NCS)/surgical package cost ×100) for mastectomy. In a private hospital, it was 0.01%, whereas, in a public hospital, it was 0.17%. The cost savings (%) generated using TCS were greater than the incremental cost increase across all SSI incidences and TCS efficacy rates.

Sensitivity analysis

The sensitivity analysis for four variables is shown in the Tornado graph below. The base value cost savings for mastectomy from a private hospital and a public hospital is INR 27,299 [Figure 4] and INR 2,958 [Figure 5], respectively, implicating that TCS has a greater impact on reducing SSI, thus, resulting in total cost saving.
Figure 4: One-way sensitivity analysis. Tornado graph showing one-way sensitivity analysis for mastectomy based on probabilistic methods for a private hospital

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Figure 5: One-way sensitivity analysis. Tornado graph showing one-way sensitivity analysis for mastectomy based on probabilistic methods for a public hospital

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  Discussion Top


This retrospective analysis included one retrospective study[12] and five prospective studies[9],[10],[13],[14],[15] that provided a comprehensive overview of the SSI incidence in India. In addition, the findings also concentrated on recent cost data to evaluate the efficacy of TCS on the total cost of care in a private and public hospital. The evidence of efficacy for oncology surgical procedure (mastectomy) from prospective, RCTs, and other study designs included in this study were based on the decision-tree cost model, suggesting that TCS should be used for surgeries because it not only reduces the risk of SSI but also leads to cost savings.[16]

Our findings demonstrate that the cost saving obtained using TCS was 10 times higher at a private hospital in comparison with the public hospital. The cost savings obtained using TCS differed primarily with the SSI incidence (%) and TCS efficacy rate, where the cost savings increased with an increase in SSI (%). Further, our sensitivity analysis showed no significant impact on cost saving because the cost of either suture, TCS, or NCS was ± 20% of the base cost. In addition to cost savings, we found a reduction in SSI that resulted in an improved patient outcome, in turn, leading to the availability of more beds for newer patients in public settings in India. Our study failed to evaluate the indirect cost of productivity loss associated with SSI, which is an important consideration for policymakers for making informed decisions.

Even though our analysis was sensitive to efficacy, it did not differentiate incisional SSI from superficial to deep or gave wound classification. However, from a societal perspective, it was economical because it improved patient outcomes, including the direct cost related to hospital stay and treatment. Further, another limitation of our study was that we included kinds of literature that included the risk of SSI across both a private and public hospital that may differ in reality. Future prospective studies are required that should take into consideration SSI wound classification while evaluating sutures. This will allow comparing different studies and different types of SSI to gain more insights about the efficacy of the sutures.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Rothenburger S, Spangler D, Bhende S, Burkley D. In Vitro antimicrobial evaluation of coated VICRYL* plus antibacterial suture (coated polyglactin 910 with triclosan) using zone of inhibition assays. Surg Infect (Larchmt) 2002;3:s79-87.  Back to cited text no. 1
    
2.
Jungwirth-Weinberger A, Grubhofer F, Imam MA, Bachmann E, Wirth S. Mechanical properties of Triclosan sutures: Mechanical properties of triclosan sutures. J Orthop Res 2018;36:1777-82.  Back to cited text no. 2
    
3.
Leaper D, Assadian O, Hubner N-O, McBain A, Barbolt T, Rothenburger S, et al. Antimicrobial sutures and prevention of surgical site infection: assessment of the safety of the antiseptic triclosan. Int Wound J 2011;8:556-66.  Back to cited text no. 3
    
4.
Leaper D, McBain AJ, Kramer A, Assadian O, Sanchez JL, Lumio J, et al. Healthcare associated infection: novel strategies and antimicrobial implants to prevent surgical site infection. Ann R Coll Surg Engl 2010;92:453-8.  Back to cited text no. 4
    
5.
Wu X, Kubilay NZ, Ren J, Allegranzi B, Bischoff P, Zayed B, et al. Antimicrobial-coated sutures to decrease surgical site infections: A systematic review and meta-analysis. Eur J Clin Microbiol Infect Dis 2017;36:19-32.  Back to cited text no. 5
    
6.
Konstantelias AA, Andriakopoulou CSI, Mourgela S. Triclosan-coated sutures for the prevention of surgical-site infections: A meta-analysis. Acta Chir Belg 2017;117:137-48.  Back to cited text no. 6
    
7.
Yamashita K, Takeno S, Hoshino S, Shiwaku H, Aisu N, Yoshida Y, et al. Triclosan sutures for surgical site infection in colorectal cancer. J Surg Res 2016;206:16-21.  Back to cited text no. 7
    
8.
Smith K, Robertson DP, Lappin DF, Ramage G. Commercial mouthwashes are ineffective against oral MRSA biofilms. Oral Surg Oral Med Oral Pathol Oral Radiol 2013;115:624-9.  Back to cited text no. 8
    
9.
Lilani SP, Jangale N, Chowdhary A, Daver GB. Surgical site infection in clean and clean-contaminated cases. Indian J Med Microbiol 2005:249-52.  Back to cited text no. 9
[PUBMED]  [Full text]  
10.
Akhter MSJ, Verma R, Madhukar KP, Vaishampayan AR, Unadkat PC. Incidence of surgical site infection in postoperative patients at a tertiary care centre in India. J Wound Care 2016;25:210-7.  Back to cited text no. 10
    
11.
Leaper DJ, Edmiston CE. World Health Organization: Global guidelines for the prevention of surgical site infection. J Hosp Infect 2017;95:135-6.  Back to cited text no. 11
    
12.
Ashraf M, Biswas J, Gupta S, Alam N. Determinants of wound infections for breast procedures: Assessment of the risk of wound infection posed by an invasive procedure for subsequent operation. Int J Surg 2009;7:543-6.  Back to cited text no. 12
    
13.
Fadnis M, Desai S, Bharadwaj R. Surgical site infections in tertiary care hospital. IJHBR 2014;2:152-61.  Back to cited text no. 13
    
14.
Jain P, Gill H, Abbey R, Singh A. Study of surgical site infections in a Tertiary Care Hospital in a rural area of North India. PaGe 2015;2:127-32.  Back to cited text no. 14
    
15.
Sasikumari O, Sreekumary P, Jayalekha B. The bacterial profile of surgical site infection occurring within one week after surgery in a tertiary care centre. JACM 2016;18:86-90.  Back to cited text no. 15
    
16.
Williams N, Sweetland H, Goyal S, Ivins N, Leaper DJ. Randomized Trial of Antimicrobial-Coated Sutures To Prevent Surgical Site Infection after Breast Cancer Surgery. Surg. Infect 2011;12:469-74.  Back to cited text no. 16
    
17.
Zhang Z-T, Zhang H-W, Fang X-D, Wang L-M, Li X-X, Li Y-F, et al. Cosmetic outcome and surgical site infection rates of antibacterial absorbable (Polyglactin 910) suture compared to Chinese silk suture in breast cancer surgery: a randomized pilot research. Chin Med J 2011;124:719-24.  Back to cited text no. 17
    


    Figures

  [Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5]
 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5]



 

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