Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT05032625 |
| Other study ID # |
12943 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2019 |
| Est. completion date |
September 1, 2020 |
Study information
| Verified date |
August 2021 |
| Source |
New York Medical College |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
There is significant mortality associated with necrotizing soft tissue infections, it is
imperative to decrease mortality and complications associated with this disease is
determined. To accomplish this goal, study team will create a prospectively maintained
database of all NSTI patients admitted at department of surgery. Investigators will asses the
predictors of poor outcome and follow these patients for 1 year in clinic and asses the
functional quality of life by incorporating 36-Item Short Form Survey (SF-36) score.
Description:
RATIONALE AND BACKGROUND Necrotizing soft tissue infections (NSTIs) are severe
life-threatening, rapidly-spreading, soft tissue infections of the subcutaneous tissue,
fascia, or muscle caused by bacteria. Due to the rapid progression of disease, early
diagnosis and treatment are crucial to a patient's survival.
Given the aggressive nature of these infections and the significant mortality associated with
them, it is imperative that the optimal standard of care to decrease mortality and
complications associated with this disease is determined. To accomplish this goal, study team
will create a prospectively maintained database of all NSTI patients admitted at department
of surgery. Investigators will follow these patients for 1 year in clinic and asses the
functional quality of life by incorporating 36-Item Short Form Survey (SF-36) score. This
RAND 36-Item Health Survey (Version 1.0) taps eight health concepts: physical functioning,
bodily pain, role limitations due to physical health problems, role limitations due to
personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and
general health perceptions. It is a validated scale freely available for research to assess
the quality of life after surgery.
Primary Objectives:
The short term objectives are to evaluate 30-day mortality and to establish the predictors of
poor outcome. The long term objectives are to measure quality of life after NSTI.
CHARACTERISTICS OF THE STUDY POPULATION
Target Population The study population will include all patients ≥ 18 years presenting with
necrotizing soft tissue infections admitted to Westchester Medical Center, who will undergo
surgical management
Subject Recruitment All patients admitted with a diagnosis of NSTI who undergo or about to
undergo surgery for NSTI and meet initial screening criteria will be approached by the
surgeon to determine if patient will agree to participate in the research study. The PI or PI
approved research personnel will explain the study to the patient or their legally authorized
representative (LAR). The patient/LAR will be given adequate time to ask questions and
consider participation in this study. Should the patient agree to be in the study, the PI or
PI-approved research personnel will have the patient/LAR fill out the consent and HIPAA forms
and they will be given a copy of both documents.
Study Design This study will be a prospective observational study. There will be no study
related interventions.
Study Duration Investigators aim to enroll approximately 300 subjects between three years.
Each patient will be followed for 1 year. Therefore, we expect the study will be open for at
least 4 years. 3 years for enrollment and 1 year to complete the data analysis and
manuscript.
DATA PROCEDURES
1. Data Collection Patients will be identified by the Department of Surgery morning report
and by Emergency General Surgeons. The Emergency General Surgeons (listed at the beginning of
the protocol), will notify the Department of Surgery's Clinical Research (DSCRU) unit when a
patient meets study criteria. After obtaining consent, the patients will be followed up for
one year. Data will be collected at the following time points: Pre-operative, Operative,
Post-Operative ,2- month post-op, 4- months post-op, 8- months post-op and 1 year post-op.
Preoperative:
Demographics: age, sex, race and ethnicity Comorbidities: anemia, bleeding disorder, cancer,
cardiac disease, chronic urinary tract infection, dialysis, hyperlipidemia,
hypo/hyper-thyroidism, immunocompromised, prior infection, liver disease, obesity, peripheral
vascular disease, renal disease, diabetes, hypertension and Transplant.
Social History: recreational drug use, tobacco and alcohol. Medications: use of
anticoagulants and antiplatelets, Vitals: systolic blood pressure (SBP), diastolic blood
pressure (DBP), heart rate (HR), temperature (temp), respiratory rate (resp. rate), height,
weight and BMI (body mass index, Modified frailty index (Mfi) and Charleston's comorbidity
index Lab reports: the lab tests that are done as standard of care during the hospital stay
will be collected. The following lab values will be collected for the study only if they are
available in subject's medical record: hemoglobin, hematocrit, white blood count
(differential), sodium, BUN (blood urea nitrogen), lactate, pH, glucose, creatinine, platelet
count, histopathology and culture for microbiology of the tissues resected during surgery,
coagulation profile (PT (prothrombin time)/PTT (partial thromboplastin time) /aPTT (activated
partial thromboplastin time), cultures from blood, urine, sputum, trachea, wound and
peritoneal fluid will be collected as well.
Intraoperative:
Duration of surgery: start time and end time Amount and type of fluids Received: IV fluids
and blood products received General: Number of drains, planned/unplanned procedures and
amount of blood loss Type and number/s of surgery: Time from admission to Ist debridement
(days), time from admission to 2nd debridement (days), time from admission to 3rd debridement
(days, time from admission to 4th debridement (days, time from admission to 5tht debridement
(days), amputation of limb (Y/N). Wound size depth (cm) (on every subsequent debridement)
Postoperative:
General: date of discharge, time of discharge, hospital length of stay, intensive care unit
length of stay, (ICU LOS), ventilator days, transfer back to ICU, time of drain removal and
mortality. Antibiotics (Regimen, combination, duration), hyperbaric oxygen therapy (HBOT)
(Y/N), infectious disease consulted (Y/N) Complications: wound infection. Pneumonia, acute
kidney injury, multi-organ dysfunction, sepsis, urinary tract infection, venous thrombosis,
pulmonary embolism, adult respiratory distress syndrome Disposition: home, acute
rehabilitation center, subacute rehabilitation center.
Follow up:
Investigators will follow patients for 1 year after discharge. Follow-up visits are done in
the clinic after 2 weekss, 1 month, 2-months, 4-months, 8-months and 1 year of discharge. We
will examine surgical site, asses pain, 36-Item Short Form Survey (SF-36) scores
The research staff will review each chart and retrieve the information included in the data
collection form (please see attached). After data is collected, the research team along with
the Principal Investigator along with all Co-Investigators will analyze the data.
Statistical Analysis Chi-square difference tests will be used to assess significant
differences in predictors on categorical outcomes. T-tests will be used to assess mean
differences in predictors on continuous outcomes. Univariable and multivariable logistic
regression analyses will be conducted for outcomes such as all-cause mortality, pneumonia,
sepsis, and multi-organ failure. Univariable and multivariable linear regression will be
performed for hospital length of stay.
