Clean-cut study

Background and Introduction:

Surgical site infection (SSI) accounts for 15% of all nosocomial infections and, among surgical patients, represents the most common nosocomial infection. Postsurgical infection leads to increased length of postoperative hospital stay, drastically escalated expense, higher rates of hospital readmission, and jeopardized health outcomes. Accordingly, the first step in the treatment of SSIs is in their prevention. (1)

Implementation of the checklist can lead to significant improvements in many of the standards considered essential for safe surgery. In 2009 WHO, published results from the implementation of a Safe Surgery Checklist, which showed that appropriate use of the checklist reduced complications by 36% and overall mortality following surgery by nearly 50%.(2) Since this work, numerous studies have supported the findings that effective use of a checklist is associated with improved outcomes for surgical patients.(3-8)Checklist served as a simple solution, and its introduction was widely applicable and measurable, without adding additional potential harm or excessive costs to the delivery of surgical care.

Clean Cut is a checklist-based quality improvement program designed to guide facilities through the steps of improving perioperative infection prevention processes and reducing surgical site infections (SSIs).

Strategy:

We will develop and mature a surgical infection prevention and control program at ACTRECHospital Kharghar, Navi Mumbai. We will use checklist-based system to identify problems in compliance with surgical infection prevention standards. We will collect baseline data on compliance to direct our efforts. We will identify local champions from surgical, anesthesia, and nursing staff to provide insights into root cause and help identify improvement opportunities. The Lifebox team will provide guidance and help organize and coordinate the actual implementation, but the project will be based on local insight and processes. We will monitor and evaluate processes and patient outcomes throughout the duration of the study.

Project Objective:

Establish a program for surgical site infection prevention, to identify process problems and potential solutions.

Proposed Process Measures:

1. Compliance to the safe surgical checklist

2. Efficacy of skin preparation

3. Violations of sterile drapes and gowns

4. Confirmation of instrument sterility

5. Timing of antibiotic administration

6. Appropriate swab counts

Proposed Outcome Measures:

1. Postoperative wound infection

2. Length of stay

3. Need for reoperation

4. Mortality

Study methodology:

Study Overview: The observational study will be conducted in ACTREC Hospital, Kharghar. Clean Cut is a checklist-based quality improvement program designed to guide facilities through the steps of improving perioperative infection prevention processes and reducing surgical site infections (SSIs). Clean Cut takes a multifaceted approach to improving perioperative team adherence to best practices, engaging the whole surgical environment to achieve the program’s objectives. It will include data collection of all elective cases posted for surgery, irrespective of the age and gender for a period of 1 month of baseline data followed by 1year of improvement program. Details of the infection control prevention practices will be noted. A 30 day follow up will be done to determine the incidence of surgical site infections.

It includes:

➢ Appropriate skin preparation of both the surgeon’s hands and surgical site with antiseptic agents

➢ Maintenance of sterile field by ensuring the integrity of surgical gowns, drapes, gloves

➢ Proper confirmation of instrument sterility by operating team

➢ Appropriate antibiotic administration within one hour prior to surgical incision to optimize prophylaxis

➢ Complete swab/ gauge counts before and after every case

➢ Use of Surgical Safety Checklist to promote teamwork, communication and a culture of safety in operating room

Data collectors will be trained in how to appropriately complete the data collection forms, a process to be supervised by Investigators. Investigators will review all data collected for completeness and plausibility. Incomplete forms will be returned to the data collectors for further clarification. Investigators will help coordinate programmatic details and logistics.

Baseline data will be collected on operations occurring in these rooms. During implementation of the project, staff members will have a locally-modified checklist available for use as a quality improvement tool to improve compliance with the infection prevention and control standards. Use of this checklist will be at the discretion of the clinical staff and surgical team members. Enrollment will include all patients who undergo surgical intervention, regardless of age, gender, or diagnosis.

Data collection:

During the 1-year period, data collectors will directly observe cases posted for elective surgery,which will ensure that cases are captured at all times of the day. Data will be recorded on the Data Collection Sheet (Appendix I). Only operations that are directly observed by the trained data collectors will be included in the analysis. Once the baseline data is completed (~100 cases or all the elective cases for a period of initial 1 month undergoing head and neck surgeries), the data will be evaluated to characterize gaps in staff adherence to infection prevention standards. An improvement program based on identified gaps will be implemented to bring perioperative infection standards into compliance with the checklist. Data collection will continue during this implementation phase.

The temporal extent of data collection per patient will be either the duration of hospitalization or thirty days postop, whichever is shorter. Outcomes for all study patients will be collected prospective chart review and communication with the clinical team caring for the patient.

Data Transmission, Protection, and Storage:

All identifiable patient data will be collected and stored on site. Data will be collected, de-identified, and converted into an Excel document. Data transmission will only occur with this de-identified information no less frequently than once a week, and stored on a secure file compliant with Tata Memorial Center. Each patient will be assigned a unique study identification number to facilitate data queries and audit. As soon as feasible, data collection will be done electronically through District Health Information Software(DHIS2) or a similarly protected and encrypted data capture mechanism.

Confidentiality:

The information in the study record will be kept confidential and clinical charts will be housed in the ACTREC/CRS. Data will be stored securely and will be made available only to the person conducting the study unless you specifically give permission in writing to do so otherwise. Patients will be identified by a unique number.

 

Ethical consideration:

There is no foreseeable harm resulting from participation in the study, as this is a quality improvement observational study and all rights of the participant will be safeguarded and protected.