| 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 ACTREC
Hospital 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.
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