Surgical Site Infection Rate After Intra-Abdominal Surgery Using Negative Pressure Wound Therapy at Initial Closure

Duration of individual study participation will last approximately one year for prospectively enrolled participants. Data collection for retrospectively enrolled patients will span approximately 12 months. Study data will not be collected on subjects until eligibility is confirmed and the patient is assigned a study number. All information will be collected in a secure study-specific electronic registry database. The data will be reviewed for completeness and accuracy by the Principal Investigator. This is an observational registry which does not include an investigatory agent and poses minimal risk to the participants. Thus, the monitoring will be done by the study personnel - an independent board is not necessary. This study will use the descriptions and grading scales found in the revised National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 4. Information about all adverse events, whether volunteered by the subject, discovered by the investigator, or detected through physical examination, laboratory test, or other means, will be collected, recorded, and followed as appropriate. All adverse events experienced by participants will be collected and reported from the time of consent until the Day 30 follow-up appointment, as appropriate. Thereafter, only adverse events of interest (i.e., death, additional hospitalization, surgical site infection, surgical site occurrence) will be recorded. Participants who have an ongoing adverse event related to the study procedures may continue to be periodically contacted by a member of the study staff until the event has resolved or determine to be irreversible by the principal investigator. All adverse events and serious adverse events will be reported to the Johns Hopkins Medicine Institutional Review Board. To generate a large data set that may be used to answer various research questions, enrollment will continue for at least 10 years, generating an estimated patient sample size of n=1200. The study team anticipates enrolling 100-150 patients in the study registry per year over 10 years. Simple descriptive statistics will be used to determine the rate of SSIs in colorectal surgery patients. This rate will be compared with the SSI rate published in literature to determine if implementation of negative pressure wound therapy wound closure following colorectal surgery decreases the rate of SSIs in colorectal surgery patients. A hypothesis test will be used to determine if there is a difference before and after adoption of negative pressure wound therapy wound closure. Enrollment of subjects over several years will enable further analyses with the possibility of stratification according to different patient characteristics.