There are three methods for closure of wounds that result from surgeries or trauma: sutures, staples, and skin adhesives. The purpose of this project is to compare each of these skin closure approaches in terms of the types of skin wounds and the patient populations they are used for along with short-term outcomes, such as need for additional procedures, wound dehiscence, and health services use. Our scientific team of physicians, patients, informaticians, and researchers will: define a set of surgical procedures and trauma-related lacerations in order to characterize a study cohort; specify a set of clinical features to describe the cohort; define each of the wound closure comparator methods; and, specify the clinical features for the outcomes. Once these scientific specifications are developed, the PEDSnet data science team will craft a statistical query based on the PCORnet common data model to evaluate as many of the clinical criteria as possible. The query will then be executed in the PEDSnet and OneFlorida data networks that include analysis-ready electronic health records, and results will be evaluated by the scientific team. We will then develop case abstraction forms that will be used for chart reviews of samples of adults and children from the overall cohort. We expect that chart review will be necessary to define the type of skin closure and details for some of the outcomes. Results of this study will provide novel information on the effects of alternative skin closure methods for different types of procedures.
Specific Aims and Significance:
To accomplish the study’s purpose, the project will:
Aim 1: Contrast the patient populations undergoing wound closure with sutures, staples, and skin adhesives.
Aim 2: Compare the short-term outcomes—inclusive of site reactions, wound dehiscence, site infection, need for additional wound closure procedures, and healthcare service use--of wounds closed with sutures, staples, and skin adhesives.
Patient Population of Interest and Outcomes:
There are two cohorts of interest: individuals undergoing wound closure after surgery and as a result of trauma-induced lacerations. We will include patients of all ages and will define surgeries of interest in collaboration with the scientific team. The following endpoints will be evaluated:
- Application site reactions: contact dermatitis, rash, inflammation, swelling
- Wound dehiscence
- Surgical site infection
- Patient’s length of stay in hospital
- Readmission or prolongation of hospitalization due to wound complications
Real-World Data and Data Quality:
PEDSnet: Maintains an extensive data quality assessment (DQA) program in its data management. This process has two goals. First, it works to maximize the quality of data available in the traditional sense of the word "quality", that is, to find and correct errors in the collection or standardization of data. This process begins with 746 tests done on data from each PEDSnet site in each quarterly data cycle. Secondly, the DQA program also lets us describe the operating characteristics of the data in several dimensions. This is especially relevant because PEDSnet collects data obtained during "real world" clinical settings, providing researchers with a window into clinical care.
OneFlorida: The OneFlorida Data Trust is a repository of statewide health-care data that is regularly updated with the inclusion of new partners and data refreshes from existing partners. The Data Trust contains claims and encounter data for Floridians enrolled in Medicaid and robust patient-level electronic health record data from public and private health care systems, including diagnoses, procedures, medications, patient demographics, unique patient codes for re-identification by consortium partners and other data elements in the PCORnet Common Data Model (CDM). In total, the Data Trust contains data for more than 15 million Floridians.
Study Design and Methods:
We will use a nonconcurrent (i.e., retrospective) cohort study design in which the comparator groups will be defined by type of skin closure. These groups will be contrasted on the risk of any of the negative outcomes and each specific outcome for which adequate numbers of events are available. We will characterize the socio-demographic and clinical characteristics of each of the comparator groups and the sub-groups experiencing each of the outcomes. We will develop proportional hazards models to identify risk factors for each outcome.This study will require chart reviews to extract the type of skin closure, and possibly some information related to outcomes from surgical notes and Emergency Department (ED) visit physician notes. These methods will be combined with queries of each of the two data networks.