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Trial record 2 of 4 for:    19535947 [PUBMED-IDS]

Effect of Standard Normothermia Protocol On Surgical Site Infections

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ClinicalTrials.gov Identifier: NCT02961244
Recruitment Status : Completed
First Posted : November 10, 2016
Results First Posted : May 11, 2017
Last Update Posted : December 12, 2017
Sponsor:
Information provided by (Responsible Party):
Ali Kadir Değirmenci, Dokuz Eylul University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Condition Surgical Site Infection
Interventions Other: Prewarming and perioperative warming with Forced Air Warming device and its blankets.
Device: Forced Air Warming blanket
Enrollment 118
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.
Arm/Group Title Control Group Intervention Group
Hide Arm/Group Description Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming.

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

Period Title: Overall Study
Started 64 64
Patients Excluded During Randomization 0 1
Completed 63 55
Not Completed 1 9
Reason Not Completed
Protocol Violation             0             1
Withdrawal by Subject             1             2
Surgery plan change after study approval             0             2
Lost to Follow-up             0             2
İnadequate data             0             2
Arm/Group Title Control Group Intervention Group Total
Hide Arm/Group Description Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming.

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

Total of all reporting groups
Overall Number of Baseline Participants 63 55 118
Overall Number of Units Analyzed
Type of Units Analyzed: Patients
63 55 118
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 63 participants 55 participants 118 participants
58.0  (14.3) 57.6  (12.9) 57.8  (13.6)
[1]
Measure Description: For age variable, groups were homogeneous. (p=0.870)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 55 participants 118 participants
Female
34
  54.0%
23
  41.8%
57
  48.3%
Male
29
  46.0%
32
  58.2%
61
  51.7%
[1]
Measure Description: For gender variable, groups were homogeneous. (p=0.190)
BMI   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilograms per square meter
Number Analyzed 63 participants 55 participants 118 participants
26.6  (4.9) 26.8  (4.4) 26.7  (4.7)
[1]
Measure Description: For BMI variable, groups were homogeneous. (p=0.836)
Weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 63 participants 55 participants 118 participants
72.8  (14.9) 75.3  (14.5) 74  (14.7)
[1]
Measure Description: For weight variable, groups were homogeneous. (p=0.346)
Height   [1] 
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 63 participants 55 participants 118 participants
165.1  (8.6) 167.3  (8.7) 166.0  (8.0)
[1]
Measure Description: For height variable, groups were homogeneous. (p=0.166)
Ethiology   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 55 participants 118 participants
Hepatopancreaticobiliary System Etiology
24
  38.1%
10
  18.2%
34
  28.8%
Colorectal Tract Etiology
32
  50.8%
32
  58.2%
64
  54.2%
Upper Gastointestinal Tract
7
  11.1%
13
  23.6%
20
  16.9%
[1]
Measure Description: Etiologies including hepatopancreaticobiliary, colorectal, upper gastrointestinal systems diseases .
Smoking habit   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 55 participants 118 participants
Nonsmoker
30
  47.6%
26
  47.3%
56
  47.5%
Smoking History
33
  52.4%
29
  52.7%
62
  52.5%
[1]
Measure Description: For smoking habit both groups were homogenous.(p=0.893)
Alcohol Use   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 55 participants 118 participants
Alcohol use (<2 glass)
61
  96.8%
52
  94.5%
113
  95.8%
Alcohol use (≥2 glass)
2
   3.2%
3
   5.5%
5
   4.2%
[1]
Measure Description: For alcohol use, groups were homogeneous. (p=0.541)
Type of anesthesia   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 55 participants 118 participants
General anesthesia
16
  25.4%
15
  27.3%
31
  26.3%
General and epidural anesthesia
29
  46.0%
20
  36.4%
49
  41.5%
General and intrathecal anesthesia
18
  28.6%
20
  36.4%
38
  32.2%
[1]
Measure Description: For anesthesia choice, groups were homogeneous. (p=0.655)
Epidural catheter removal time if any inserted   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 29 participants 20 participants 49 participants
5.07  (2.3) 5.09  (2) 5.08  (2.2)
[1]
Measure Description: For epidural catheher removal time, groups were homogeneous. (p=0.973)
[2]
Measure Analysis Population Description: For patients only had had epidural catheter inserted.
Central venous access   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 55 participants 118 participants
Not used
18
  28.6%
21
  38.2%
39
  33.1%
Used temporary methods
33
  52.4%
20
  36.4%
53
  44.9%
Permenant central venous port previously inserted
12
  19.0%
14
  25.5%
26
  22.0%
[1]
Measure Description: For cetral venous access choice groups were homogeneous. (p=0.107)
If only temporary, removal time of central venous catheter   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 33 participants 20 participants 53 participants
6.09  (3.7) 7.2  (2.6) 6.5  (3.4)
[1]
Measure Description: For temporary central venous catheter removing time both groups were homogenous. (p=0.259)
[2]
Measure Analysis Population Description: For patients only had had temporary central venous catheter inserted.
Operating Room Temperature   [1] 
Mean (Standard Deviation)
Unit of measure:  ºC degrees
Number Analyzed 63 Patients 55 Patients 118 Patients
21.3  (2) 21.5  (2) 21.4  (2)
[1]
Measure Description: For operating room temperature variable, groups were homogeneous. (p=0.059)
İntraoperative blood loss   [1] 
Mean (Standard Deviation)
Unit of measure:  Liters
Number Analyzed 63 participants 55 participants 118 participants
0.23  (0.3) 0.26  (0.36) 0.24  (0.33)
[1]
Measure Description: For intraoperative blood loss data, groups were homogeneous. (p=0.614)
İntraoperative red cell transfusion   [1] 
Mean (Standard Deviation)
Unit of measure:  Units
Number Analyzed 63 participants 55 participants 118 participants
0.24  (0.58) 0.33  (0.74) 0.25  (0.6)
[1]
Measure Description: For intraoperative red cell transfusion variable, groups were homogeneous. (p=0.470)
Intraoperative fresh frozen plasma transfusion  
Mean (Standard Deviation)
Unit of measure:  Units
Number Analyzed 63 participants 55 participants 118 participants
0  (0) 0.018  (0.134) 0.008  (0.009)
Intraoperative cristalloid fluid   [1] 
Mean (Standard Deviation)
Unit of measure:  Liters
Number Analyzed 63 participants 55 participants 118 participants
3.06  (1.38) 3.01  (1.4) 3.04  (1.38)
[1]
Measure Description: For cristalloid fluid infusement amounts, groups were homogeneous. (p=0.855)
Intraoperative colloid fluid   [1] 
Mean (Standard Deviation)
Unit of measure:  Liters
Number Analyzed 63 participants 55 participants 118 participants
0.42  (0.57) 0.33  (0.42) 0.38  (0.5)
[1]
Measure Description: For colloid fluid infusement amounts, groups were homogeneous. (p=0.361)
Intraoperative urine output   [1] 
Mean (Standard Deviation)
Unit of measure:  Liters
Number Analyzed 63 participants 55 participants 118 participants
0.77  (0.71) 0.7  (0.57) 0.74  (0.64)
[1]
Measure Description: For peroperative urine output, groups were homogeneous. (p=0.559)
Mean heart rate   [1] 
Mean (Standard Deviation)
Unit of measure:  Beats per minute
Number Analyzed 63 participants 55 participants 118 participants
78  (13.4) 75.8  (14.5) 77  (13.9)
[1]
Measure Description: For mean heart rate amounts, groups were homogeneous. (p=0.390)
Intraoperative mean arterial blood pressure   [1] 
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 63 participants 55 participants 118 participants
89.1  (13.2) 87  (7) 88.1  (13.4)
[1]
Measure Description: For intraoperative mean arterial blood pressure levels, groups were homogeneous. (p=0.388)
Operation duration   [1] 
Mean (Standard Deviation)
Unit of measure:  Minutes
Number Analyzed 63 participants 55 participants 118 participants
239.6  (118.3) 199.9  (106.3) 221.1  (114)
[1]
Measure Description: For operation duration , groups were homogeneous. (p=0.059)
Perioperative hemoglobin levels   [1] 
Mean (Standard Deviation)
Unit of measure:  G/dl
Number Analyzed 63 participants 55 participants 118 participants
Preoperative 11.81  (1.49) 11.8  (1.35) 11.81  (1.42)
Postoperative 1. Day 11.0  (1.58) 11.19  (1.54) 11.09  (1.55)
∆(Hemoglobin) 0.80  (1.22) 0.61  (1.10) 0.71  (1.16)
[1]
Measure Description: Preoperative (p=0.984), postoperative first day (p=0.526) and ∆(Hemoglobin)(the difference between preoperative and postoperative first day levels)(p=0.385)
Perioperative albumin levels   [1] 
Mean (Standard Deviation)
Unit of measure:  G/dl
Number Analyzed 63 participants 55 participants 118 participants
Preoperative 3.74  (0.46) 3.66  (0.5) 3.71  (0.48)
Postoperative 1. Day 2.86  (0.56) 2.96  (0.5) 2.91  (0.53)
∆(Albumin) 0.88  (0.51) 0.69  (0.5) 0.79  (0.51)
[1]
Measure Description: Preoperative (p=0.359), postoperative first day (p=0.314) and ∆(Albumin)(the difference between preoperative and postoperative first day levels)(p=0.055)
Profilactic antibiotics   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 55 participants 118 participants
Cefazolin
30
  47.6%
22
  40.0%
52
  44.1%
Cefuroxime + metronidazole
30
  47.6%
32
  58.2%
62
  52.5%
Ceftriaxone
1
   1.6%
1
   1.8%
2
   1.7%
Ceftriaxone+ metronidazole
1
   1.6%
0
   0.0%
1
   0.8%
Amoxicillin + clavulanate
1
   1.6%
0
   0.0%
1
   0.8%
[1]
Measure Description: There were not enough numbers in all boxes so statistical analyses not appropriate to assess for this title.
Duration of Hospitalization Parameters   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Days
Total Duration of Hospitalization Number Analyzed 63 participants 55 participants 118 participants
18.96  (18.62) 19.4  (10.49) 19.25  (15.28)
Preoperative Duration of Hospitalization Number Analyzed 63 participants 55 participants 118 participants
6.87  (5.91) 7.47  (6.49) 7.15  (6.17)
Postoperative Duration of Hospitalization Number Analyzed 63 participants 55 participants 118 participants
12.09  (15.54) 12.1  (9.07) 12.1  (12.88)
Duration of ICU Hospitalization Number Analyzed 16 participants 11 participants 27 participants
3.5  (5.68) 3.45  (7.48) 3.48  (6.33)
[1]
Measure Description: Between two groups duration of hospitalizations were not statistically different including parameters of Total Duration of Hospitalization (p=0.879), Preoperative Duration of Hospitalization (p=0.601), Postoperative Duration of Hospitalization (0.995) and Duration of ICU Hospitalization (0.346).
[2]
Measure Analysis Population Description: In our study 11 patients from intervention group and 16 patients from control group needed ICU follow up after surgery. (p=0.348)
Simple Hospitalization costs   [1] 
Mean (Standard Deviation)
Unit of measure:  Thousand Turkish liras
Number Analyzed 63 participants 55 participants 118 participants
12.6  (9.8) 11.7  (6.1) 12.2  (8.3)
[1]
Measure Description: These data is not result of standardized (like in the literature suggests) costs data.These data made by our patients data system which can calculate goverments payments fees, etc for any procedure performed to any patient. (intervention based data ) (p=0.524)
Perioperative Warming   [1] [2] 
Measure Type: Number
Unit of measure:  Participants
Peroperatuar Warming Number Analyzed 63 participants 55 participants 118 participants
63 55 118
Postoperative Warming Number Analyzed 13 participants 55 participants 68 participants
13 47 60
[1]
Measure Description: There were not enough numbers in all boxes so statistical analyses not appropriate to assess for preoperative and peroperative warming. Postoperative warming choices were significiantly different between two groups as excepted because of study protocols contents.(p<0.001)
[2]
Measure Analysis Population Description: Preoperative Warming which is not our center's traditional method for routine maintaining normothermia procedures, performed for only and to all of intervention group patients . For this reason it is not inculed to this analyze table.
Surgical Site Classification   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 55 participants 118 participants
Clean
4
   6.3%
2
   3.6%
6
   5.1%
Clean-Contaminated
58
  92.1%
52
  94.5%
110
  93.2%
Contaminated
1
   1.6%
1
   1.8%
2
   1.7%
[1]
Measure Description:

During the preoperative patient's approval period, if surgical site is predicted as contaminated and dirty, these patients not appropriate for study. (preoperatively) In 2 patients preoperatively appropriate was found that peroperatively they had closed microperforation of tumor.Though minimal contamination detected perioperatively and there were not any clinical findings of infection, they accepted as contaminated.

There were not enough numbers in all boxes so statistical analyses not appropriate to assess.

ASA Score   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 55 participants 118 participants
ASA 1
22
  34.9%
19
  34.5%
41
  34.7%
ASA 2
32
  50.8%
29
  52.7%
61
  51.7%
ASA 3
9
  14.3%
7
  12.7%
16
  13.6%
[1]
Measure Description: For ASA scores groups were homogeneous. (p=0.943) ASA 4,5,6 is not shown because of the study inclusion criterias. (ASA which has known as American Society of Anesthesiologists Physical Status, min. 1 and max. 6). Definitions: ASA 1-Normal healthy patients, ASA 2-A patient with mild systemic disease. ASA 3-A Patient with severe systemic disease, ASA4-A patient with severe systemic disease that is a constant threat to life, ASA5-A moribund patient who is not expected to survive without the operation, ASA6-A declared brain-dead patient whose organs are being removed for donor purposes)
NNISS Score   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 55 participants 118 participants
<2
52
  82.5%
46
  83.6%
98
  83.1%
≥2
11
  17.5%
9
  16.4%
20
  16.9%
[1]
Measure Description: For NNISS scores groups were homogeneous. (p=0.875) NNISS Score which has known as The National Nosocomial Infections Surveillance System Scoring System used for prediction of the risk of Surgical Site İnfections (SSI).The NNIS basic SSI risk index is composed of the following criteria: American Society of Anesthesiologists score of 3, 4, or 5 (>2 takes one score; wound class( contaminated or dirty takes one point; and duration of surgery (There are percantile times defined and above 75 percantile, score takes one point) NNISS Score may be 0 to 3, and SSI risks were increased by score.
SENIC Score   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 55 participants 118 participants
<3
57
  90.5%
48
  87.3%
105
  89.0%
≥3
6
   9.5%
7
  12.7%
13
  11.0%
[1]
Measure Description:

For SENIC scores groups were homogeneous. (0.581) This Scoring system has known as Study on Efficacy of Nosocomial Infection Control (SENIC) project's SSI Risk Scoring System (Min. 0 to max. 4 points may be calculated , risk of SSI incerases by score ). 4 criterias include duration of surgery (>2 hours), abdominal surgery, wound class( contaminated or dirty takes one point) and comorbidities (>2) which is any of them is one points.

Because of the participants who in each score (0-4) was not enough to analyse statisticaly, participants divided into two groups. (<3 and ≥3)

Comorbidities   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 55 participants 118 participants
Congestive Heart Failure
1
   1.6%
2
   3.6%
3
   2.5%
Pulmonary Circulation Disorders
0
   0.0%
5
   9.1%
5
   4.2%
Complicated Hypertension
2
   3.2%
4
   7.3%
6
   5.1%
Uncomplicated Hypertension
19
  30.2%
19
  34.5%
38
  32.2%
Chronic Respiratory Diseases
2
   3.2%
4
   7.3%
6
   5.1%
Uncomplicated Diabetes
11
  17.5%
10
  18.2%
21
  17.8%
Complicated Diabetes
0
   0.0%
3
   5.5%
3
   2.5%
Hypothyroidism
8
  12.7%
3
   5.5%
11
   9.3%
Lymphoma
1
   1.6%
1
   1.8%
2
   1.7%
Metastatic Cancer
16
  25.4%
11
  20.0%
27
  22.9%
Non-metastatic Solid Tumor
45
  71.4%
43
  78.2%
88
  74.6%
Other(Valvuler, collagen tissue, etc diseases)
4
   6.3%
1
   1.8%
5
   4.2%
[1]
Measure Description: There were not enough numbers in all boxes so statistical analyses not appropriate to assess for this title. Buy for classifaciton of the comobidities, Elixhauser Classification used for standart data presentation.
Perioperative Temperature Measurements   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  ºC degrees
Perioperative Minimum Measurement Number Analyzed 63 participants 55 participants 118 participants
35.17  (0.59) 35.76  (0.52) 35.44  (0.63)
Preoperative Room Enterance Temperature Number Analyzed 63 participants 55 participants 118 participants
36.94  (0.47) 36.94  (0.46) 36.94  (0.46)
Preoperative Room Exit Temperature Number Analyzed 63 participants 55 participants 118 participants
37.03  (0.4) 36.89  (0.5) 36.96  (0.46)
After Entubation Temperature Number Analyzed 63 participants 55 participants 118 participants
36.36  (0.6) 36.66  (0.46) 36.5  (0.56)
Postentubation 60. minutes Temperature Number Analyzed 63 participants 55 participants 118 participants
35.74  (0.62) 36.16  (0.56) 35.9  (0.62)
Postentubation 120. minutes Temperature Number Analyzed 63 participants 55 participants 118 participants
35.8  (0.73) 36.28  (0.6) 35.9  (0.76)
Postentubation 180. minutes Temperature Number Analyzed 63 participants 55 participants 118 participants
35.63  (0.86) 36.25  (0.72) 35.88  (0.86)
Postentubation 240. minutes Temperature Number Analyzed 63 participants 55 participants 118 participants
35.5  (0.82) 36.45  (0.87) 35.85  (0.95)
After Extubation Temperature Number Analyzed 63 participants 55 participants 118 participants
35.88  (0.74) 36.54  (0.67) 36.21  (0.77)
Recovery Room Enterance Temperature Number Analyzed 63 participants 55 participants 118 participants
35.84  (0.75) 36.41  (0.64) 36.12  (0.75)
Recovery Room ExitTemperature Number Analyzed 63 participants 55 participants 118 participants
36.48  (0.62) 36.7  (0.61) 36.59  (0.62)
Service Enterance Temperature Number Analyzed 47 participants 44 participants 91 participants
36.31  (0.42) 36.35  (0.38) 36.33  (0.4)
ICU Enterance Temperature (ICU patients) Number Analyzed 16 participants 11 participants 27 participants
35.78  (0.95) 36.08  (0.64) 35.89  (0.85)
[1]
Measure Description: Perioperative Minimum Measurement p<0.001 Preoperative Room Enterance Temperature p=0.980 Preoperative Room Exit Temperature p=0.094 After Entubation Temperature p=0.011 Postentubation 60. minutes Temperature p<0.001 Postentubation 120. minutes Temperature p<0.001 Postentubation 180. minutes Temperature p=0.001 Postentubation 240. minutes Temperature p=0.001 After Extubation Temperature p<0.001 Recovery Room Enterance Temperature p<0.001 Recovery Room ExitTemperature p=0.094 Service Enterance Temperature p=0.716
[2]
Measure Analysis Population Description:

In our study 11 patients from intervention group and 16 patients from control group needed ICU follow-up after surgery. For this reason ICU patient's measurements were not including service data.

Also these measurements were not including 300, 360, 420, 480, 540, 600 minutes data.Because most of the patients operation times are less than 6 hours.

Infectious Complications   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 55 participants 118 participants
No İnfectious Complications
42
  66.7%
43
  78.2%
85
  72.0%
Pulmonary
4
   6.3%
1
   1.8%
5
   4.2%
Urinary
2
   3.2%
2
   3.6%
4
   3.4%
Bacteriemia
3
   4.8%
1
   1.8%
4
   3.4%
SSI
18
  28.6%
9
  16.4%
27
  22.9%
[1]
Measure Description: Our study's main outcome which is SSI is significiantly different between two groups.(p=0.044)
SSI Classification  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 55 participants 118 participants
Superficial Incisional
10
  15.9%
6
  10.9%
16
  13.6%
Deep Incisional
3
   4.8%
1
   1.8%
4
   3.4%
Organ-Space
5
   7.9%
2
   3.6%
7
   5.9%
ASEPSIS Total Scores   [1] 
Mean (Standard Deviation)
Unit of measure:  Points
Number Analyzed 63 participants 55 participants 118 participants
17.83  (13.83) 12.64  (10.6) 15.41  (12.67)
[1]
Measure Description: ASEPSIS Wound Scoring System used in our study. ASEPSIS postoperative total Points (p=0.029) was different between two groups. Simply points are given for the need for Additional treatment, the presence of Serous discharge, Erythema, Purulent exudate, and Separation of the deep tissues, the Isolation of bacteria, and the duration of inpatient Stay (ASEPSIS). (min. is 0 points and max. doesn't have any limit but 0-10 points is succesful, 11-20 points is impaired healing and 21-30 points is mild, 31-40 is moderate, >41 points is severe SSI.)
1.Primary Outcome
Title Surgical Site Infection Rate
Hide Description

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
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Hide Analysis Population Description
Patients and their results assessed on the basis of intention to treat per protocole.
Arm/Group Title Control Group Intervention Group
Hide Arm/Group Description:
Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming.

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

Overall Number of Participants Analyzed 63 55
Measure Type: Count of Participants
Unit of Measure: Participants
19
  30.2%
8
  14.5%
2.Secondary Outcome
Title Maintaining Normothermia Rate
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients and their results assessed on the basis of intention to treat per protocole.
Arm/Group Title Control Group Intervention Group
Hide Arm/Group Description:
Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming.

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

Overall Number of Participants Analyzed 63 55
Measure Type: Count of Participants
Unit of Measure: Participants
7
  11.1%
26
  47.3%
Time Frame Within the postoperative 30 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Group Intervention Group
Hide Arm/Group Description Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming.

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

All-Cause Mortality
Control Group Intervention Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Control Group Intervention Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/63 (0.00%)      0/55 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.008%
Control Group Intervention Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/63 (0.00%)      1/55 (1.82%)    
Product Issues     
Thermal Discomfort   0/63 (0.00%)  0 1/55 (1.82%)  1
Indicates events were collected by systematic assessment
Surgical etiologies were various.It was a single-centered trial whose power was 80%.The room temperatures could not be kept constant.The number of samples were not enough to make variate analysis of SSI and hypothermia risk factors.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Ali Kadir Degirmenci
Organization: Dokuz Eylul University Medicine Faculty, General Surgery Department
Phone: +902324122901
Publications:
Sessler DI. Perioperative thermoregulation. Geriatr Anesthesiol. 2008;6736(15):107-22
Clinical practice guideline: The management of inadvertent perioperative hypothermia in adults National Collaborating Centre for Nursing and Supportive Care commissioned by National Institute for Health and Clinical Excellence. 2008;88-92, 204-445
Arslan NC, Terzi C, Kaya Ozlem, et. al. Perioperative Body Temperature: One Day Prevalence Study İn One Hospital. XVI. Annual Meeting of the European Society of Surgery Abstract Book 2012; 667-886
Llewellyn L. Effect of Pre-warming on Reducing the Incidence of Inadvertent Peri-operative Hypothermia for Patients Undergoing General Anaesthesia: A Mini-review. Br J Anaesth Recover Nurs. 2013;14(1-2):3-10
Responsible Party: Ali Kadir Değirmenci, Dokuz Eylul University
ClinicalTrials.gov Identifier: NCT02961244     History of Changes
Other Study ID Numbers: 870-GOA
First Submitted: November 1, 2016
First Posted: November 10, 2016
Results First Submitted: January 6, 2017
Results First Posted: May 11, 2017
Last Update Posted: December 12, 2017