Surgical Site Infection
Conditions
Keywords
Surgical Site Infection, normothermia, hypothermia, prewarming
Brief summary
Aim of this study is to investigate the efficiency of a standard normothermia protocol and effects on postoperative Surgical Site Infection (SSI) rate.
Interventions
OTHERPrewarming and perioperative warming with Forced Air Warming device and its blankets.
Sponsors
Dokuz Eylul University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Elective * Preoperatively not infected/dirty Surgical Site * Open major abdominal operations (hepatobiliary, upper gastrointestinal or colorectal); under general anesthesia, longer than 30 minutes)
Exclusion criteria
* Emergent surgery * Local/locoregional procedures * Laparoscopic operation * Minor abdominal operations (e.g. hernia repair, colostomy closure) * Malign hyperthermia * Signs of active infection or fever * Immunosuppression * Severe malnutrition * Kidney/liver failure and antibiotic use within the previous 1 week or immunosuppressive use (chemotherapy, steroids.) within the previous 1 month and reversal of patients opinion while randomization period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Site Infection Rate | Postoperative 30 days | Within the postoperative 30 days, if there is purulent exudate or nonpurulent but culture was pozitive, we accepted them as Surgical Site Infection (SSI) diagnosed. All patients were made enough incision wide to explore their entire abdomen defined as Major Abdominal Surgery . With this results between two groups intervention group had lesser rates of SSI respectively( (p=0.045 Mann Whitney U, n\<30), (p=0.044 chi-square ) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maintaining Normothermia Rate | Surgery day | Within the surgery day, from patient bed through the operating room to PACU or ICU or back to patient bed. With these results our intervention group's maintaining normothermia rates were higher respectively. ( p=0.001) For each patients around 11 temperature measurement had been made according to the operation time . If any measurement of any patients was \<36 ºC , that patient accepted as hypothermic. (Failure to maintain normothermia) |
Participant flow
Recruitment details
Between June 2013 and December 2015 elective, preoperatively not infected/dirty, open major abdominal operations under general anesthesia, longer than 30 minutes and over 18 aged were included in the study. Primary outcome was comparison of SSI rates between groups and secondary was effects of protocol to normothermia.
Pre-assignment details
Exclusion criteria were emergent surgery, local/locoregional procedures, laparoscopic operations, minor abdominal operations, malign hyperthermia, signs of active infection/fever, immunosuppression, malnutrition, kidney/liver failure, antibiotic use within the previous 1 week/ımmunsupresive use within previous 1 month, reversal of approval.
Participants by arm
| Arm | Count |
|---|---|
| Control Group Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming. | 63 |
| Control Group Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming. | 63 |
| Intervention Group Perioperative management and warming was performed according to a standard normothermia protocol with active prewarming.
Prewarming and perioperative warming with Forced Air Warming device and its blankets.
Forced Air Warming blanket | 55 |
| Intervention Group Perioperative management and warming was performed according to a standard normothermia protocol with active prewarming.
Prewarming and perioperative warming with Forced Air Warming device and its blankets.
Forced Air Warming blanket | 55 |
| Total | 236 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | İnadequate data | 0 | 2 |
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Surgery plan change after study approval | 0 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Intervention Group | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 57.6 years STANDARD_DEVIATION 12.9 | 58.0 years STANDARD_DEVIATION 14.3 | 57.8 years STANDARD_DEVIATION 13.6 |
| Alcohol Use Alcohol use (<2 glass) | 52 Participants | 61 Participants | 113 Participants |
| Alcohol Use Alcohol use (≥2 glass) | 3 Participants | 2 Participants | 5 Participants |
| ASA Score ASA 1 | 19 Participants | 22 Participants | 41 Participants |
| ASA Score ASA 2 | 29 Participants | 32 Participants | 61 Participants |
| ASA Score ASA 3 | 7 Participants | 9 Participants | 16 Participants |
| ASEPSIS Total Scores | 12.64 points STANDARD_DEVIATION 10.6 | 17.83 points STANDARD_DEVIATION 13.83 | 15.41 points STANDARD_DEVIATION 12.67 |
| BMI | 26.8 kilograms per square meter STANDARD_DEVIATION 4.4 | 26.6 kilograms per square meter STANDARD_DEVIATION 4.9 | 26.7 kilograms per square meter STANDARD_DEVIATION 4.7 |
| Central venous access Not used | 21 Participants | 18 Participants | 39 Participants |
| Central venous access Permenant central venous port previously inserted | 14 Participants | 12 Participants | 26 Participants |
| Central venous access Used temporary methods | 20 Participants | 33 Participants | 53 Participants |
| Comorbidities Chronic Respiratory Diseases | 4 Participants | 2 Participants | 6 Participants |
| Comorbidities Complicated Diabetes | 3 Participants | 0 Participants | 3 Participants |
| Comorbidities Complicated Hypertension | 4 Participants | 2 Participants | 6 Participants |
| Comorbidities Congestive Heart Failure | 2 Participants | 1 Participants | 3 Participants |
| Comorbidities Hypothyroidism | 3 Participants | 8 Participants | 11 Participants |
| Comorbidities Lymphoma | 1 Participants | 1 Participants | 2 Participants |
| Comorbidities Metastatic Cancer | 11 Participants | 16 Participants | 27 Participants |
| Comorbidities Non-metastatic Solid Tumor | 43 Participants | 45 Participants | 88 Participants |
| Comorbidities Other(Valvuler, collagen tissue, etc diseases) | 1 Participants | 4 Participants | 5 Participants |
| Comorbidities Pulmonary Circulation Disorders | 5 Participants | 0 Participants | 5 Participants |
| Comorbidities Uncomplicated Diabetes | 10 Participants | 11 Participants | 21 Participants |
| Comorbidities Uncomplicated Hypertension | 19 Participants | 19 Participants | 38 Participants |
| Duration of Hospitalization Parameters Duration of ICU Hospitalization | 3.45 days STANDARD_DEVIATION 7.48 | 3.5 days STANDARD_DEVIATION 5.68 | 3.48 days STANDARD_DEVIATION 6.33 |
| Duration of Hospitalization Parameters Postoperative Duration of Hospitalization | 12.1 days STANDARD_DEVIATION 9.07 | 12.09 days STANDARD_DEVIATION 15.54 | 12.1 days STANDARD_DEVIATION 12.88 |
| Duration of Hospitalization Parameters Preoperative Duration of Hospitalization | 7.47 days STANDARD_DEVIATION 6.49 | 6.87 days STANDARD_DEVIATION 5.91 | 7.15 days STANDARD_DEVIATION 6.17 |
| Duration of Hospitalization Parameters Total Duration of Hospitalization | 19.4 days STANDARD_DEVIATION 10.49 | 18.96 days STANDARD_DEVIATION 18.62 | 19.25 days STANDARD_DEVIATION 15.28 |
| Epidural catheter removal time if any inserted | 5.09 days STANDARD_DEVIATION 2 | 5.07 days STANDARD_DEVIATION 2.3 | 5.08 days STANDARD_DEVIATION 2.2 |
| Ethiology Colorectal Tract Etiology | 32 Participants | 32 Participants | 64 Participants |
| Ethiology Hepatopancreaticobiliary System Etiology | 10 Participants | 24 Participants | 34 Participants |
| Ethiology Upper Gastointestinal Tract | 13 Participants | 7 Participants | 20 Participants |
| Height | 167.3 centimeters STANDARD_DEVIATION 8.7 | 165.1 centimeters STANDARD_DEVIATION 8.6 | 166.0 centimeters STANDARD_DEVIATION 8 |
| If only temporary, removal time of central venous catheter | 7.2 days STANDARD_DEVIATION 2.6 | 6.09 days STANDARD_DEVIATION 3.7 | 6.5 days STANDARD_DEVIATION 3.4 |
| Infectious Complications Bacteriemia | 1 Participants | 3 Participants | 4 Participants |
| Infectious Complications No İnfectious Complications | 43 Participants | 42 Participants | 85 Participants |
| Infectious Complications Pulmonary | 1 Participants | 4 Participants | 5 Participants |
| Infectious Complications SSI | 9 Participants | 18 Participants | 27 Participants |
| Infectious Complications Urinary | 2 Participants | 2 Participants | 4 Participants |
| İntraoperative blood loss | 0.26 liters STANDARD_DEVIATION 0.36 | 0.23 liters STANDARD_DEVIATION 0.3 | 0.24 liters STANDARD_DEVIATION 0.33 |
| Intraoperative colloid fluid | 0.33 liters STANDARD_DEVIATION 0.42 | 0.42 liters STANDARD_DEVIATION 0.57 | 0.38 liters STANDARD_DEVIATION 0.5 |
| Intraoperative cristalloid fluid | 3.01 liters STANDARD_DEVIATION 1.4 | 3.06 liters STANDARD_DEVIATION 1.38 | 3.04 liters STANDARD_DEVIATION 1.38 |
| Intraoperative fresh frozen plasma transfusion | 0.018 units STANDARD_DEVIATION 0.134 | 0 units STANDARD_DEVIATION 0 | 0.008 units STANDARD_DEVIATION 0.009 |
| Intraoperative mean arterial blood pressure | 87 mm Hg STANDARD_DEVIATION 7 | 89.1 mm Hg STANDARD_DEVIATION 13.2 | 88.1 mm Hg STANDARD_DEVIATION 13.4 |
| İntraoperative red cell transfusion | 0.33 units STANDARD_DEVIATION 0.74 | 0.24 units STANDARD_DEVIATION 0.58 | 0.25 units STANDARD_DEVIATION 0.6 |
| Intraoperative urine output | 0.7 liters STANDARD_DEVIATION 0.57 | 0.77 liters STANDARD_DEVIATION 0.71 | 0.74 liters STANDARD_DEVIATION 0.64 |
| Mean heart rate | 75.8 beats per minute STANDARD_DEVIATION 14.5 | 78 beats per minute STANDARD_DEVIATION 13.4 | 77 beats per minute STANDARD_DEVIATION 13.9 |
| NNISS Score <2 | 46 Participants | 52 Participants | 98 Participants |
| NNISS Score ≥2 | 9 Participants | 11 Participants | 20 Participants |
| Operating Room Temperature | 21.5 ºC degrees STANDARD_DEVIATION 2 | 21.3 ºC degrees STANDARD_DEVIATION 2 | 21.4 ºC degrees STANDARD_DEVIATION 2 |
| Operation duration | 199.9 minutes STANDARD_DEVIATION 106.3 | 239.6 minutes STANDARD_DEVIATION 118.3 | 221.1 minutes STANDARD_DEVIATION 114 |
| Perioperative albumin levels ∆(Albumin) | 0.69 g/dl STANDARD_DEVIATION 0.5 | 0.88 g/dl STANDARD_DEVIATION 0.51 | 0.79 g/dl STANDARD_DEVIATION 0.51 |
| Perioperative albumin levels Postoperative 1. Day | 2.96 g/dl STANDARD_DEVIATION 0.5 | 2.86 g/dl STANDARD_DEVIATION 0.56 | 2.91 g/dl STANDARD_DEVIATION 0.53 |
| Perioperative albumin levels Preoperative | 3.66 g/dl STANDARD_DEVIATION 0.5 | 3.74 g/dl STANDARD_DEVIATION 0.46 | 3.71 g/dl STANDARD_DEVIATION 0.48 |
| Perioperative hemoglobin levels ∆(Hemoglobin) | 0.61 g/dl STANDARD_DEVIATION 1.1 | 0.80 g/dl STANDARD_DEVIATION 1.22 | 0.71 g/dl STANDARD_DEVIATION 1.16 |
| Perioperative hemoglobin levels Postoperative 1. Day | 11.19 g/dl STANDARD_DEVIATION 1.54 | 11.0 g/dl STANDARD_DEVIATION 1.58 | 11.09 g/dl STANDARD_DEVIATION 1.55 |
| Perioperative hemoglobin levels Preoperative | 11.8 g/dl STANDARD_DEVIATION 1.35 | 11.81 g/dl STANDARD_DEVIATION 1.49 | 11.81 g/dl STANDARD_DEVIATION 1.42 |
| Perioperative Temperature Measurements After Entubation Temperature | 36.66 ºC degrees STANDARD_DEVIATION 0.46 | 36.36 ºC degrees STANDARD_DEVIATION 0.6 | 36.5 ºC degrees STANDARD_DEVIATION 0.56 |
| Perioperative Temperature Measurements After Extubation Temperature | 36.54 ºC degrees STANDARD_DEVIATION 0.67 | 35.88 ºC degrees STANDARD_DEVIATION 0.74 | 36.21 ºC degrees STANDARD_DEVIATION 0.77 |
| Perioperative Temperature Measurements ICU Enterance Temperature (ICU patients) | 36.08 ºC degrees STANDARD_DEVIATION 0.64 | 35.78 ºC degrees STANDARD_DEVIATION 0.95 | 35.89 ºC degrees STANDARD_DEVIATION 0.85 |
| Perioperative Temperature Measurements Perioperative Minimum Measurement | 35.76 ºC degrees STANDARD_DEVIATION 0.52 | 35.17 ºC degrees STANDARD_DEVIATION 0.59 | 35.44 ºC degrees STANDARD_DEVIATION 0.63 |
| Perioperative Temperature Measurements Postentubation 120. minutes Temperature | 36.28 ºC degrees STANDARD_DEVIATION 0.6 | 35.8 ºC degrees STANDARD_DEVIATION 0.73 | 35.9 ºC degrees STANDARD_DEVIATION 0.76 |
| Perioperative Temperature Measurements Postentubation 180. minutes Temperature | 36.25 ºC degrees STANDARD_DEVIATION 0.72 | 35.63 ºC degrees STANDARD_DEVIATION 0.86 | 35.88 ºC degrees STANDARD_DEVIATION 0.86 |
| Perioperative Temperature Measurements Postentubation 240. minutes Temperature | 36.45 ºC degrees STANDARD_DEVIATION 0.87 | 35.5 ºC degrees STANDARD_DEVIATION 0.82 | 35.85 ºC degrees STANDARD_DEVIATION 0.95 |
| Perioperative Temperature Measurements Postentubation 60. minutes Temperature | 36.16 ºC degrees STANDARD_DEVIATION 0.56 | 35.74 ºC degrees STANDARD_DEVIATION 0.62 | 35.9 ºC degrees STANDARD_DEVIATION 0.62 |
| Perioperative Temperature Measurements Preoperative Room Enterance Temperature | 36.94 ºC degrees STANDARD_DEVIATION 0.46 | 36.94 ºC degrees STANDARD_DEVIATION 0.47 | 36.94 ºC degrees STANDARD_DEVIATION 0.46 |
| Perioperative Temperature Measurements Preoperative Room Exit Temperature | 36.89 ºC degrees STANDARD_DEVIATION 0.5 | 37.03 ºC degrees STANDARD_DEVIATION 0.4 | 36.96 ºC degrees STANDARD_DEVIATION 0.46 |
| Perioperative Temperature Measurements Recovery Room Enterance Temperature | 36.41 ºC degrees STANDARD_DEVIATION 0.64 | 35.84 ºC degrees STANDARD_DEVIATION 0.75 | 36.12 ºC degrees STANDARD_DEVIATION 0.75 |
| Perioperative Temperature Measurements Recovery Room ExitTemperature | 36.7 ºC degrees STANDARD_DEVIATION 0.61 | 36.48 ºC degrees STANDARD_DEVIATION 0.62 | 36.59 ºC degrees STANDARD_DEVIATION 0.62 |
| Perioperative Temperature Measurements Service Enterance Temperature | 36.35 ºC degrees STANDARD_DEVIATION 0.38 | 36.31 ºC degrees STANDARD_DEVIATION 0.42 | 36.33 ºC degrees STANDARD_DEVIATION 0.4 |
| Perioperative Warming Peroperatuar Warming | 55 participants | 63 participants | 118 participants |
| Perioperative Warming Postoperative Warming | 47 participants | 13 participants | 60 participants |
| Profilactic antibiotics Amoxicillin + clavulanate | 0 Participants | 1 Participants | 1 Participants |
| Profilactic antibiotics Cefazolin | 22 Participants | 30 Participants | 52 Participants |
| Profilactic antibiotics Ceftriaxone | 1 Participants | 1 Participants | 2 Participants |
| Profilactic antibiotics Ceftriaxone+ metronidazole | 0 Participants | 1 Participants | 1 Participants |
| Profilactic antibiotics Cefuroxime + metronidazole | 32 Participants | 30 Participants | 62 Participants |
| SENIC Score <3 | 48 Participants | 57 Participants | 105 Participants |
| SENIC Score ≥3 | 7 Participants | 6 Participants | 13 Participants |
| Sex: Female, Male Female | 23 Participants | 34 Participants | 57 Participants |
| Sex: Female, Male Male | 32 Participants | 29 Participants | 61 Participants |
| Simple Hospitalization costs | 11.7 Thousand Turkish liras STANDARD_DEVIATION 6.1 | 12.6 Thousand Turkish liras STANDARD_DEVIATION 9.8 | 12.2 Thousand Turkish liras STANDARD_DEVIATION 8.3 |
| Smoking habit Nonsmoker | 26 Participants | 30 Participants | 56 Participants |
| Smoking habit Smoking History | 29 Participants | 33 Participants | 62 Participants |
| SSI Classification Deep Incisional | 1 Participants | 3 Participants | 4 Participants |
| SSI Classification Organ-Space | 2 Participants | 5 Participants | 7 Participants |
| SSI Classification Superficial Incisional | 6 Participants | 10 Participants | 16 Participants |
| Surgical Site Classification Clean | 2 Participants | 4 Participants | 6 Participants |
| Surgical Site Classification Clean-Contaminated | 52 Participants | 58 Participants | 110 Participants |
| Surgical Site Classification Contaminated | 1 Participants | 1 Participants | 2 Participants |
| Type of anesthesia General and epidural anesthesia | 20 Participants | 29 Participants | 49 Participants |
| Type of anesthesia General and intrathecal anesthesia | 20 Participants | 18 Participants | 38 Participants |
| Type of anesthesia General anesthesia | 15 Participants | 16 Participants | 31 Participants |
| Weight | 75.3 kilograms STANDARD_DEVIATION 14.5 | 72.8 kilograms STANDARD_DEVIATION 14.9 | 74 kilograms STANDARD_DEVIATION 14.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 63 | 1 / 55 |
| serious Total, serious adverse events | 0 / 63 | 0 / 55 |
Outcome results
Primary
Surgical Site Infection Rate
Within the postoperative 30 days, if there is purulent exudate or nonpurulent but culture was pozitive, we accepted them as Surgical Site Infection (SSI) diagnosed. All patients were made enough incision wide to explore their entire abdomen defined as Major Abdominal Surgery . With this results between two groups intervention group had lesser rates of SSI respectively( (p=0.045 Mann Whitney U, n\<30), (p=0.044 chi-square )
Time frame: Postoperative 30 days
Population: Patients and their results assessed on the basis of intention to treat per protocole.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Surgical Site Infection Rate | 19 Participants |
| Intervention Group | Surgical Site Infection Rate | 8 Participants |
Secondary
Maintaining Normothermia Rate
Within the surgery day, from patient bed through the operating room to PACU or ICU or back to patient bed. With these results our intervention group's maintaining normothermia rates were higher respectively. ( p=0.001) For each patients around 11 temperature measurement had been made according to the operation time . If any measurement of any patients was \<36 ºC , that patient accepted as hypothermic. (Failure to maintain normothermia)
Time frame: Surgery day
Population: Patients and their results assessed on the basis of intention to treat per protocole.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Maintaining Normothermia Rate | 7 Participants |
| Intervention Group | Maintaining Normothermia Rate | 26 Participants |