This study was initiated by the WHO Collaboration Centre (WHOCC) for surgical care delivery in LMICs, Mumbai, India, in collaboration with the Association of Rural Surgeons of India (ARSI) with the aim to describe the prevalent perioperative infection control practices in rural and semi-urban hospitals and document the rates of SSIs in these hospitals.
This was a prospective observational study performed in two phases. First phase was a cross-sectional study which consisted of administration of a questionnaire enquiring into the perioperative SSI prevention practices and recruiting the centres for phase two. The second phase was conducted as a prospective cohort study aimed at documenting the rate and the factors affecting SSIs in the participant hospitals (Figure 1).
We conducted the first phase in November 2019 at the ‘Association of Rural Surgeons of India (ARSI)’ annual conference, which is an annual gathering of surgeons practicing in the rural and semi-urban areas of India. We assessed the infection control practices of the participant centres through a pre-designed questionnaire. The questionnaire was based on the World Health Organisation (WHO) Surgical Practices Guidelines, 2018 with few modifications to suit the Indian setting (11). Before distributing the questionnaire, we made a short presentation at the gathering, explaining the components of the questionnaire and the two phases of the proposed study. Only practitioners representing healthcare centres based in rural and semi-urban areas in India catering to a population of up to 100000 were included (12). We excluded surgeons practising in urban areas from this study.
The questionnaire included details of the geographical location of the healthcare centres represented by these surgeons, a brief facility assessment, and the surgical patient load. The main focus was on the perioperative practices: like appropriate skin preparation (both surgeon’s hands and surgical site), hand washing before surgery, maintenance of the sterile surgical field, confirmation of instrument sterility, appropriate antimicrobial prophylaxis and timing of administration, complete gauze/swab counts (mop counts) after surgeries, and the use of surgical safety checklist (13). We added a few parameters like the presence of in-house microbiology facility, availability of running water in the operation theatres (OTs) and usage of prophylactic antimicrobials beyond the OT, to suit the Indian setting based on the literature reviewed (14,15). We included a question to indicate willingness to participate in the second phase of the study in the questionnaire. Adequate knowledge about duration for hand wash was defined as per WHO criteria for surgical handrub (16). Usage of iodophors, chlorhexidine gluconate and alcohol-based scrubs was defined as ‘appropriate surgical scrub’ (16).
We contacted the participants who were willing to participate in phase II of this study. Adult patients aged 18 years and above undergoing general surgical and obstetrics-gynaecological procedures needing anaesthesia were invited to participate in the study. Patients undergoing any orthopaedic procedure were excluded.
SSI was defined as infection that occurs after surgery in the part of the body where surgery took place within 30-days in the post-operative period (2). We collected data of all consecutive operated patients over one month in the recruited centres. The surgeons chose the time period based on their convenience at their respective centres. Each participant was followed up to 30 days postoperatively and evaluated for the occurrence of SSIs, hence, the study period extended up to 2 months (60 days). Prospective data collection was performed between January to March 2020 and August to October 2020. It was prolonged due to the cancellation of all elective surgical work in view of the COVID-19 pandemic from April to July 2020.
We shared audio-visual material after necessary permissions, about identification and diagnostic criteria for SSIs with the surgeons and/or representatives of the participating centres [Supplementary material 1 -https://globalsurg.org/ssi/index.html#/1]. Also, standard definitions for wound class and SSI diagnostic criteria were printed behind each data collection form for ready reference for the person collecting data. We had regular telephonic conversations with representatives from the participant centres for guidance and troubleshooting during the recruitment as well as follow-up period. The printed data collection form (proforma) included patient demographics, clinical details of the surgery, perioperative infection control practices, antimicrobial usage, and timing and noting of postoperative wound checks at various intervals [Supplementary Material 2]. SSIs diagnosed anytime during the first wound check (2nd or 3rd postoperative day), at suture removal (after 7th postoperative day) or at any point of time during the 30-day follow-up period were recorded [Supplementary Material 3].
The data from each of these centres were collected on paper forms which were then sent to the WHOCC based in Mumbai. The data from both phases was entered on Microsoft Excel.
The main outcome measures for the two phases were adherence to the perioperative infection control practices and the rate of SSIs at the participant centres, respectively. The secondary outcome measures were factors associated with SSI like age, gender, American Society of Anaesthesiologists’ (ASA) physical status class, wound class, and type of surgery.
The statistical analysis was performed using Microsoft Excel statistical software 2019. The chi-square test was performed to determine the statistical significance of any associations between categorical variables and a p value of ≤0.05 was considered as statistically significant.
The Ethics approval for the study was provided by ARSI through Martin Luther Christian University Research Ethics Committee.