Long-Term Sustainability of Peri-Operative Infection Control Practices: Implementation of “Clean Cut,” a Checklist-Based Quality Improvement Program in India

Abstract

Introduction:

Surgical site infections (SSIs) are a substantial healthcare burden in low- and middle- income countries. “Clean Cut” is a checklist-based infection prevention and control (IPC) program intended to improve compliance to peri-operative IPC standards. We aim to study the short-term and long-term impact of its implementation in a tertiary care cancer referral center.

Methods:

This was a single institute, prospective interventional study. Patients undergoing elective head-neck surgical procedures were included. The “Clean Cut” program consisting of surveillance, audits, and IPC training was implemented for 6 months, after which there was no active oversight. Post-intervention (T2) and 1-year follow-up (T3) data regarding compliance to core IPC practices and SSI rates were compared with baseline (T1).

Results:

One hundred eighty six patients were included with 50 (26.9%), 86 (46.2%), and 50 (26.9%) patients at T1, T2, and T3, respectively. At baseline, teams complied with a mean of 3.56 of the six critical components of infection control processes which rose to 4.66 (p < 0.001) at T2, but decreased to 4.02 at T3 (p = 0.053). The SSI rate at baseline decreased significantly after Clean Cut implementation [16 (32%) vs. 12 (13.95%), p = 0.012], but returned to baseline levels after 1 year [17 (34%), p = 0.006].

Conclusion:

Implementation of the “Clean Cut” program increases compliance to infection control processes and reduces SSI rates in the short term. Without continuing oversight, these rates return to baseline values after 1 year.

Introduction

Standardization and widespread integration of infection control measures have led to a decrease in surgical site infection (SSI) rates in developed countries, with SSI rates for clean surgical procedures approximating 1%–4%.^1,2 However, SSI rates in low- and middle-income countries (LMICs) continue to remain high in the range of 8%–30%.^3–6 Being the most common hospital-acquired infection (HAI) in these settings, SSIs result in a substantial clinical and economic burden on the healthcare systems in LMICs, most of which are already stretched thin catering to large patient volumes with limited resources.^3,7

The World Health Organization (WHO) has recommended that “an infection prevention and control (IPC) program with a dedicated trained team should be in place in each acute healthcare facility for the purpose of preventing HAIs and combating antimicrobial resistance through IPC good practices”.⁸ Most IPC guidelines are developed in accordance with North American or European standards, with little involvement of healthcare personnel from LMICs. Even LMICs with national IPC strategies face challenges in uniform implementation of these programs due to limited resources.⁹ To address these challenges, “Lifebox”¹⁰—a non-profit organization dedicated to improving surgical safety worldwide—established “Clean Cut,” a structured IPC program for improving compliance to IPC protocols and reducing SSI rates.¹¹

Clean Cut is an adaptive, multi-modal checklist‐based program aimed at improving compliance with six critical perioperative infection prevention standards: appropriate skin and hand antisepsis, maintenance of a sterile field, instrument sterilization, appropriate prophylactic antibiotic administration, routine gauze counting, and routine use of the Surgical Safety Checklist (SSC). It emphasizes on the establishment of a locally led multi-disciplinary team, which then conducts surveillance for compliance to IPC guidelines, SSI rates, and process mapping exercises to identify IPC practice gaps and opportunities for improvement. The Clean Cut program was implemented in five hospitals in Ethiopia, which resulted in a substantial improvement in compliance to IPC processes and reduction in SSI rates at the end of 6 months.¹²

The results from the aforementioned study are encouraging and have demonstrated the efficacy of the “Clean Cut” program in reducing SSI rates without infrastructure expenses or resource investments, an aspect crucial to its widespread acceptance in LMICs. However, the question regarding the long-term sustainability of these improvements remains unanswered. Is the adherence to IPC protocols integrated into the everyday workings of the local team with sustained improvements in SSI rates, or do teams tend to lapse into old patterns in the absence of continued supervision of IPC process compliance? In this study, we aim to answer questions regarding the long-term sustainability of the improvements observed with implementation of the 6-month Clean Cut program.

Methodology

This was a prospective, single-center interventional study with the objectives of identifying deficiencies in infection control practices in the operating room, evaluating the efficacy of implementation of the Clean Cut program for a period of 6 months in reducing surgical site infections and sustainability of these improvements 1 year after implementation.

Primary endpoint of the study was SSI rate at 6 months from baseline. Secondary endpoints assessed were SSI rates 1 year after intervention and compliance to IPC practices at 6 months from baseline and 1 year after intervention.

Patient population

Patients aged 18–75 years undergoing elective surgical procedure for head and neck malignant diseases were included into the study. Patients were included at 3 different time-points: baseline (T1), 6 months after intervention (T2), and 1 year after intervention (T3). The duration of recruitment at baseline was 1 month, in which all eligible patients undergoing surgical procedure for more than a 1-month period at baseline (T1) were included into the study. Patients were recruited over a 2-month period both at T2 and T3.

Assessment of IPC practices

Data regarding compliance to SSI control processes were collected in the operating room by trained infection control nurses using a structured data collection tool (Supplementary Appendix S1) at all three time-points. Compliance of medical staff to these processes was assessed during each of the cases included in the study. The process measures assessed were classified into the six core infection control standards:

Skin and hand antisepsis

Maintenance of a sterile field

Instrument sterilization

Prophylactic antibiotic administration

Routine gauze counting, and

Routine use of the SSC.

Outcome measures

Primary outcome measure was post-operative SSI rate. Secondary outcome measures of hospital stay, rates of prolonged post-operative antibiotic usage, re-operation, post-operative pneumonia, urinary tract infections, and 30-day mortality were assessed. Outcome measures were assessed at all three time-points. Surgical site infections were defined in accordance with the 1992 CDC definition.¹³ Post-operative pneumonia and urinary tract infections were defined in accordance with the 1988 CDC definition.¹⁴ Outcome measures were assessed using structured data collection tools in the inpatient (Supplementary Appendix S2) and outpatient (Supplementary Appendix S3) setting. All data collected using the questionnaires were captured in the District Health Information Software (DHIS2).

Clean Cut program implementation

On the basis of the deficiencies detected in compliance to infection control processes, directed training as per the Clean Cut program was provided to the surgeons, anesthesiologists, scrub nurses, operating room technicians, central sterilization facility staff, and ward nurses. The Clean Cut program was implemented for a period of 6 months between time-points T1 and T2. Formal implementation of the Clean Cut intervention was stopped at the end of time period T2 with no further oversight. The details of the critical steps taken to improve compliance to SSI control practices are outlined in Table 1.

Table 1.

Critical Steps in Implementation of the Clean Cut Program

SSI control process	Intervention
Pre-incision antibiotic administration	Training on pre-operative time-out and surgical checklist compliance and accurate documentation.
Quality indicators of instrument sterility	Training provided for routine assessment of quality indicators for instrument sterility to surgical scrub nurses
Integrity of surgical drapes and gowns	Central sterilization facility and laundry facility alerted. Deficient drapes and gowns discarded. Processes for checking quality of drapes and gowns established.
	Surgical scrub nurses trained for checking surgical drape and gown quality prior to draping.
Hand hygiene	All operating room and ward staff trained through small-group workshops on hand hygiene protocols.
Infection control processes in the ward	Daily review and wound assessment by infection control nurse of post-operative patients.
	Introduction of SSI surveillance forms and regular documentation of SSI by surgeons ensured by the infection control nurse. SSI surveillance was performed using a structured data collection tool (Supplementary Appendix S4)
	Infection control team meet every 3 mos to review the data, identify deficiencies, and devise measures to curb SSI rates.
	Root cause analysis for SSI rates.
	Nursing staff education on surgical wound care and sterile practices was done at the ward level by the infection control nurse.
	Hand hygiene audits were carried out, and staff education was performed.
	Audits conducted in OR hand washing area and nurses and surgeons’ adherence to hand hygiene ensured as per WHO guidelines²¹
	Environment hygiene audits performed by infection control nurse and the microbiologist once in a month.

Statistical analysis

Data regarding compliance to SSI control practices and outcome measures at all three time-points were compared with. Categorical data were compared using a Pearson chi-square test. Continuous data were compared with using a Mann-Whitney/U test. A p-value of ≤0.05 was considered statistically significant. Statistical analysis of data was performed in IBM Corp. Released 2017. IBM SPSS Statistics for Windows, Version 25.0. Armonk, NY: IBM Corp.

Statement of ethics

This study was registered with the Clinical Trials Registry of India (CTRI/2021/07/034852) and was performed in accordance with ethical guidelines laid out in the Helsinki declaration (2008) and after obtaining approval from the institutional ethics committee.

Results

Patient characteristics

A total of 186 patients were included in this study with 50 (26.9%), 86 (46.2%), and 50 (26.9%) patients at T1, T2, and T3, respectively. Most common sites of the primary tumor were the buccal mucosa (67, 36%), tongue (62, 33.33%), and alveolus (28, 15%). The most frequently performed surgical procedures were wide local excision with mandibulectomy (32, 17.2%), bite composite resection (36, 19.35%), and glossectomy (45, 24.2%). A formal neck dissection was performed in 160 (86%) patients, of which 65 (40.6%) were bilateral. Reconstruction was performed with primary closure, local flaps, pedicled flaps, and free flaps in 63 (33.9%), 20 (10.7%), 74 (39.8%), and 29 (15.6%) patients, respectively. Patient characteristics are summarized in Table 2.

Table 2.

Patient Characteristics

	T1	T2	T3
Parameter	n = 50	n = 86	n = 50	p-value
Age (median/range)	50.5 (32–75)	48.5 (27–82)	51.5 (29–78)	0.544
Gender
Male	44 (88%)	69 (80.2%)	35 (70%)	0.081
Female	6 (12%)	17 (19.8%)	15 (30%)
Diagnosis
Buccal mucosa cancers	18 (36%)	31 (36%)	18 (36%)	0.310
Tongue cancer	16 (32%)	26 (30.2%)	20 (40%)
Cancer-alveolus	11 (22%)	15 (17.4%)	2 (4%)
Thyroid tumors	4 (8%)	7 (8.1%)	5 (10%)
Laryngeal cancer	0	1 (1.2%)	2 (4%)
Parotid tumors	0	1 (1.2%)	2 (4%
Lip cancer	0	1 (1.2%)	1 (2%)
Other	1 (2%)	4 (4.7%)	0
ASA grade
1	24 (48%)	53 (61.6%)	2 (4%)	< 0.001
2	23 (46%)	26 (30.2%)	44 (88%)
3	3 (6%)	7 (8.1%)	4 (8%)
Anemia	50 (100%)	86 (100%)	50 (100%)	1.000
Hypertension	14 (28%)	20 (23.3%)	14 (28%)	0.762
Diabetes	8 (16%)	14 (16.3%)	6 (12%)	0.779
Obesity	1 (2%)	2 (2.3%)	2 (4%)	0.793
Malnutrition	0	1 (1.2%)	1 (2%)	0.621
HIV	1 (2%)	0	0	0.255
Steroids	0	0	0	1.00

Short-term impact of the “Clean Cut” intervention

At baseline, teams complied with a mean of 3.56 of the six critical components of infection control processes. After the intervention, the compliance rose to 4.66 (p < 0.001). Only two (4%) patients at baseline complied with all six components as opposed to 20 (23.25%) patients after the intervention (p = 0.003). Nineteen (38%) patients were compliant with the surgical checklist at baseline, which increased to 80 (93%) after the intervention (p < 0.001).

The mean absolute increase in compliance across the six components from T1 to T2 was 18.38 ± 19.62%. The mean relative increase in compliance across the six components from T1 to T2 was 45.33 ± 52.8%. The increase in compliance was accompanied by a concomitant decrease in SSI rates [16 (32%) vs. 12 (13.95%), p = 0.012] and post-operative use of multiple antibiotic agents [44 (88%) vs. 12 (13.95%), p < 0.001] at T2. The compliance to individual componenents of the Clean-Cut programme have been detailed in Supplementary table S-1. There were no mortalities at either time-point or no difference in length of hospital stay [median 7 (2–36) vs. 7 (2–41) days, p = 0.732].

Long-term impact of the “Clean Cut” intervention

Teams were compliant with a mean of 4.02 of the six components at T3, which was not significantly different from the baseline value (p = 0.053). The overall compliance, as well as the compliance to the surgical checklist, reverted to the baseline value of 4% and 38%, respectively, at T3. The mean compliance rate across the six components showed an absolute decrease of 4 ± 28.25% from T2 to T3. The mean absolute change in compliance from T1 to T3 was 14.33 ± 18.9%. The mean relative change in compliance across the six components from T1 to T3 was 35.47 ± 46.43%. Post-operative SSI was observed in 17 (34%) patients at T3; a significant increase from T2 (p = 0.006). However, a concomitant increase in the use of multiple postoperative antibiotic agents was not observed [12 (13.95%) vs. 6 (12%), p = 0.409]. There were no mortalities at either time-point or no difference in length of hospital stay [median 7 (2–41) vs. 7 (3–28) days, p = 0.732]. The compliance rates to components of the “Clean Cut” program are detailed in Figure 1 and Table 3.

FIG. 1.

Radar plot of compliance rates to the six core components of Clean Cut.

Table 3.

Surgical and Pathological Details

	T1	T2	T3
Parameter	n = 50	n = 86	n = 50	p-value
Surgical Procedure
Wide local excision + neck dissection	15 (30%)	26 (30.2%)	19 (38%)	0.682
Composite resection	29 (58%)	47 (54.6%)	21 (42%)
Thyroidectomy	4 (8%)	7 (8.1%)	5 (10%)
Other	2 (4%)	6 (6.9%)	5 (10%)
Neck dissection
None	8 (16%)	12 (14%)	6 (12%)	0.882
Unilateral	27 (54%)	44 (51.2%)	24 (48%)
Bilateral	15 (30%)	30 (34.9%)	20 (40%)
Tracheostomy	10 (20%)	14 (16.3%)	11 (22%)	0.691
Reconstruction
Primary closure	17 (34%)	27 (31.4%)	19 (38%)	0.886
Local flap	6 (12%)	9 (10.5%)	5 (10%)
Pedicled flap	21 (42%)	36 (41.9%)	17 (34%)
Fascio-cutaneous free flap	4 (8%)	10 (11.6%)	4 (8%)
Osseo-cutaneous free flap	2 (4%)	4 (4.7%)	5 (10%)
Blood loss (median/range)	600 (100–2000)	500 (100–2200)	550 (100–1900)	0.340
Hospital stay (median/range)	7 (2–36)	7 (2–41)	7 (3–28)	0.732
T stage
T0	0	0	0	0.552
T1	6 (12%)	6 (7%)	1 (2%)
T2	7 (14%)	15 (17.4%)	8 (16%)
T3	6 (12%)	18 (20.9%)	12 (48%)
T4	23 (46%)	37 (43%)	24 (24%)
Tx	8 (16%)	10 (11.6%)	5 (10%)
N stage
N0	21 (42%)	53 (61.6%)	25 (50%)	0.424
N1	11 (22%)	14 (16.3%)	13 (26%)
N2	10 (20%)	10 (11.6%)	5 (10%)
N3	7 (14%)	8 (9.3%)	5 (10%)
Nx	1 (2%)	1 (1.2%)	2 (4%)
M stage
M0	49 (98%)	85 (98.8%)	49 (100%)	0.626
M1	1 (2%)	1 (1.2%)	0

Discussion

The implementation of the “Clean Cut” program at our center resulted in improvements in compliance to IPC practices, as well as a substantial reduction in SSI rates. These results were concurrent with the Ethiopian study by Forrester et al., thus validating the efficacy of Clean Cut even when implemented at a tertiary care institute such as ours. The compliance to SSI practices at baseline was, not unexpectedly, considerably greater at our institute compared with the Ethiopian data. Being a large tertiary care center, a few IPC practices were already streamlined at our institute. From the baseline data, it was evident that there was excellent compliance to the “gauze count” and “prophylactic antibiotic administration” components of the IPC practices at our institute, with a substantial scope for improvement in “surgical checklist compliance,” “skin and hand antisepsis,” “sterile surgical field,” and instrument sterility components.

There have been other studies which have implemented a variety of process improvement methods to reduce SSI rates in LMICs. Anchalia et al.¹⁵ were able to achieve a 67% reduction in SSI rates after the implementation of a 12-month-long surveillance and auditing process. Implementation of the WHO surgical checklist alone has been reported to substantially reduce SSI rates.^16,17 The studies assessing the implimentation of IPC processes in reducing SSIs in LMICs are summarized in Supplementary Table S-2.

Few authors have examined the long-term sustainability of the impact of these interventions. Kim et al.¹⁸ demonstrated that consistent use of the surgical safety checklist resulted in a 40% reduction in SSI rates over the course of 2 years. Gomez et al.¹⁹ conducted an educational intervention for healthcare practitioners regarding best prophylactic antibiotic usage. They further implemented an automated antibiotic stoppage system and incorporated it as standard of care. A 3-year follow-up showed a reduction in SSI rates by more than 50%. Starling et al.²⁰ implemented the National Nosocomial Infection Surveillance (NNIS) for more than a period of 4 years with a resultant 50% decrease in SSI rates. These studies demonstrate that it is possible to reduce SSI rates with implementation of IPC practices over the long term as well; however, the key principles underlying their success are sustained implementation of IPC practices, continued surveillance for monitoring SSIs, identification of local champions to assume leadership of multi-disciplinary IPC teams, and regular audits for continuous improvement. Our long-term follow-up data demonstrate a decrease in compliance to the IPC practices and a concomitant increase in SSI rates to baseline levels without continued oversight, highlighting the necessity of continued implementation and active surveillance of IPC practices. The present study, however, is not without its limitations. This study was performed at a single center and has a relatively small sample size at each time-point thus limiting the ability to perform a regression analysis to identify all the factors impacting SSI rates. Such an analysis performed on a larger sample size would allow more stringent analysis of the role that compliance to IPC processes plays in reduction of SSI rates. Moreover, the analysis is restricted to a single specialty of head–neck surgical procedure, the results of which may not necessarily translate to other specialties. The time period over which data collection was done is not consistent. The initial data collection over baseline was done over a shorter period as a pilot to first assess feasibility of the study, with more prolonged durations over subsequent time-points. Hence, a potential selection bias impacting the SSI rates observed in the study cannot be ruled out.

Despite the study center being one of the largest tertiary care centers, it is evident that a passive presence of IPC practices is insufficient to produce a sustained reduction in SSI rates. The ‘Clean Cut” program was designed to develop and train local teams in implementing IPC practices in a structured manner. However, it failed to induce a lasting change in the practices of the local team to be able to sustain the improvements achieved in the short term. For a process improvement program to take root, it is imperative that it equips local teams with the skills and attitudes for continued implementation of the new measures and foster a lasting culture of continuous improvement.

Conclusion

Implementation of the “Clean Cut” program resulted in a substantial increase in compliance to IPC practices with a concomitant reduction in SSI rates over 6 months. The compliance and SSI rates reverted to baseline levels after 1 year without continued oversight.

Footnotes

Acknowledgments

The authors acknowledge Sooraj Subhagan, Shyla Jacob, Prapti Shridhar Paradkar, and Deepti Wairkar for their co-operation and support during the implantation of the “Clean Cut” program at the study site.

Author Contributions

Study conceptualized by R.A., T.N., B.L., and M.T. Data collection by R.A., S.N., and A.S. Data analysis and article draft by A.K. Critical revision of the article done by R.A., S.N., T.N., B.L., and M.T.

Funding Sources

No funding or financial support was received for the research, authorship, and/or publication of this article.

Conflict of Interest

The authors have no conflicts of interest to declare.

Author Disclosure Statement

No competing financial interests exist.

Supplementary Material

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Supplementary Material

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