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Aim of this study is to investigate the efficiency of a standard normothermia protocol and effects on postoperative Surgical Site Infection (SSI) rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming. | |
| Intervention Group | Active Comparator | Perioperative management and warming was performed according to a standard normothermia protocol with active prewarming. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prewarming and perioperative warming with Forced Air Warming device and its blankets. | Other |
| ||
| Forced Air Warming blanket |
| Measure | Description | Time Frame |
|---|---|---|
| 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 ) | Postoperative 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mustafa Cem Terzi, Proffessor Doctor | Dokuz Eylul School of Medicine, General Surgery, Colorectal and Pelvic Diseases Department | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19137809 | Background | Torossian A. Thermal management during anaesthesia and thermoregulation standards for the prevention of inadvertent perioperative hypothermia. Best Pract Res Clin Anaesthesiol. 2008 Dec;22(4):659-68. doi: 10.1016/j.bpa.2008.07.006. | |
| Background | Sessler DI. Perioperative thermoregulation. Geriatr Anesthesiol. 2008;6736(15):107-22 | ||
| 23572308 |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming. |
| BG001 | Intervention Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | For age variable, groups were homogeneous. (p=0.870) |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 ) | Patients and their results assessed on the basis of intention to treat per protocole. | Posted | Count of Participants | Participants | Postoperative 30 days |
|
Within the postoperative 30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thermal Discomfort | Product Issues | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ali Kadir Degirmenci | Dokuz Eylul University Medicine Faculty, General Surgery Department | +902324122901 | alikadir@hotmail.com |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| D007035 | Hypothermia |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| Device |
|
| Surgery day |
| Background |
| Horosz B, Malec-Milewska M. Inadvertent intraoperative hypothermia. Anaesthesiol Intensive Ther. 2013 Jan-Mar;45(1):38-43. doi: 10.5603/AIT.2013.0009. |
| 14661656 | Background | Doufas AG. Consequences of inadvertent perioperative hypothermia. Best Pract Res Clin Anaesthesiol. 2003 Dec;17(4):535-49. doi: 10.1016/s1521-6896(03)00052-1. |
| Background | 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 |
| 18330074 | Background | Putzu M, Casati A, Berti M, Pagliarini G, Fanelli G. Clinical complications, monitoring and management of perioperative mild hypothermia: anesthesiological features. Acta Biomed. 2007 Dec;78(3):163-9. |
| 19137808 | Background | Reynolds L, Beckmann J, Kurz A. Perioperative complications of hypothermia. Best Pract Res Clin Anaesthesiol. 2008 Dec;22(4):645-57. doi: 10.1016/j.bpa.2008.07.005. |
| 14661653 | Background | Leslie K, Sessler DI. Perioperative hypothermia in the high-risk surgical patient. Best Pract Res Clin Anaesthesiol. 2003 Dec;17(4):485-98. doi: 10.1016/s1521-6896(03)00049-1. |
| 25837741 | Background | Torossian A, Brauer A, Hocker J, Bein B, Wulf H, Horn EP. Preventing inadvertent perioperative hypothermia. Dtsch Arztebl Int. 2015 Mar 6;112(10):166-72. doi: 10.3238/arztebl.2015.0166. |
| 18494388 | Background | Kurz A. Thermal care in the perioperative period. Best Pract Res Clin Anaesthesiol. 2008 Mar;22(1):39-62. doi: 10.1016/j.bpa.2007.10.004. |
| 7726398 | Background | Leslie K, Sessler DI, Bjorksten AR, Moayeri A. Mild hypothermia alters propofol pharmacokinetics and increases the duration of action of atracurium. Anesth Analg. 1995 May;80(5):1007-14. doi: 10.1097/00000539-199505000-00027. |
| 15781513 | Background | Fritz HG, Holzmayr M, Walter B, Moeritz KU, Lupp A, Bauer R. The effect of mild hypothermia on plasma fentanyl concentration and biotransformation in juvenile pigs. Anesth Analg. 2005 Apr;100(4):996-1002. doi: 10.1213/01.ANE.0000146517.17910.54. |
| 19535947 | Background | Polderman KH. Mechanisms of action, physiological effects, and complications of hypothermia. Crit Care Med. 2009 Jul;37(7 Suppl):S186-202. doi: 10.1097/CCM.0b013e3181aa5241. |
| 11374601 | Background | Liu M, Hu X, Liu J. The effect of hypothermia on isoflurane MAC in children. Anesthesiology. 2001 Mar;94(3):429-32. doi: 10.1097/00000542-200103000-00011. |
| 16871076 | Background | Mauermann WJ, Nemergut EC. The anesthesiologist's role in the prevention of surgical site infections. Anesthesiology. 2006 Aug;105(2):413-21; quiz 439-40. doi: 10.1097/00000542-200608000-00025. No abstract available. |
| 8606715 | Background | Kurz A, Sessler DI, Lenhardt R. Perioperative normothermia to reduce the incidence of surgical-wound infection and shorten hospitalization. Study of Wound Infection and Temperature Group. N Engl J Med. 1996 May 9;334(19):1209-15. doi: 10.1056/NEJM199605093341901. |
| 8615502 | Background | Wenisch C, Narzt E, Sessler DI, Parschalk B, Lenhardt R, Kurz A, Graninger W. Mild intraoperative hypothermia reduces production of reactive oxygen intermediates by polymorphonuclear leukocytes. Anesth Analg. 1996 Apr;82(4):810-6. doi: 10.1097/00000539-199604000-00023. |
| 10219875 | Background | Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for prevention of surgical site infection, 1999. Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol. 1999 Apr;20(4):250-78; quiz 279-80. doi: 10.1086/501620. No abstract available. |
| 12573036 | Background | Barie PS. Surgical site infections: epidemiology and prevention. Surg Infect (Larchmt). 2002;3 Suppl 1:S9-21. doi: 10.1089/sur.2002.3.s1-9. |
| Background | 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 |
| 2696565 | Background | Byrne DJ, Malek MM, Davey PG, Cuschieri A. Postoperative wound scoring. Biomed Pharmacother. 1989;43(9):669-73. doi: 10.1016/0753-3322(89)90085-1. |
| 1334988 | Background | Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG. CDC definitions of nosocomial surgical site infections, 1992: a modification of CDC definitions of surgical wound infections. Infect Control Hosp Epidemiol. 1992 Oct;13(10):606-8. No abstract available. |
| 23327981 | Background | Bratzler DW, Dellinger EP, Olsen KM, Perl TM, Auwaerter PG, Bolon MK, Fish DN, Napolitano LM, Sawyer RG, Slain D, Steinberg JP, Weinstein RA; American Society of Health-System Pharmacists; Infectious Disease Society of America; Surgical Infection Society; Society for Healthcare Epidemiology of America. Clinical practice guidelines for antimicrobial prophylaxis in surgery. Am J Health Syst Pharm. 2013 Feb 1;70(3):195-283. doi: 10.2146/ajhp120568. No abstract available. |
| 1656747 | Background | Culver DH, Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG, Banerjee SN, Edwards JR, Tolson JS, Henderson TS, et al. Surgical wound infection rates by wound class, operative procedure, and patient risk index. National Nosocomial Infections Surveillance System. Am J Med. 1991 Sep 16;91(3B):152S-157S. doi: 10.1016/0002-9343(91)90361-z. |
| 9431328 | Background | Elixhauser A, Steiner C, Harris DR, Coffey RM. Comorbidity measures for use with administrative data. Med Care. 1998 Jan;36(1):8-27. doi: 10.1097/00005650-199801000-00004. |
| 19801323 | Background | Forbes SS, Eskicioglu C, Nathens AB, Fenech DS, Laflamme C, McLean RF, McLeod RS; Best Practice in General Surgery Committee, University of Toronto. Evidence-based guidelines for prevention of perioperative hypothermia. J Am Coll Surg. 2009 Oct;209(4):492-503.e1. doi: 10.1016/j.jamcollsurg.2009.07.002. Epub 2009 Aug 20. No abstract available. |
| 18831302 | Background | Thiele RH, Huffmyer JL, Nemergut EC. The "six sigma approach" to the operating room environment and infection. Best Pract Res Clin Anaesthesiol. 2008 Sep;22(3):537-52. doi: 10.1016/j.bpa.2008.06.002. |
| 7879936 | Background | Sessler DI, Schroeder M, Merrifield B, Matsukawa T, Cheng C. Optimal duration and temperature of prewarming. Anesthesiology. 1995 Mar;82(3):674-81. doi: 10.1097/00000542-199503000-00009. |
| 22376088 | Background | Horn EP, Bein B, Bohm R, Steinfath M, Sahili N, Hocker J. The effect of short time periods of pre-operative warming in the prevention of peri-operative hypothermia. Anaesthesia. 2012 Jun;67(6):612-7. doi: 10.1111/j.1365-2044.2012.07073.x. Epub 2012 Feb 29. |
| 11567703 | Background | Melling AC, Ali B, Scott EM, Leaper DJ. Effects of preoperative warming on the incidence of wound infection after clean surgery: a randomised controlled trial. Lancet. 2001 Sep 15;358(9285):876-80. doi: 10.1016/S0140-6736(01)06071-8. |
| 17380549 | Background | Wong PF, Kumar S, Bohra A, Whetter D, Leaper DJ. Randomized clinical trial of perioperative systemic warming in major elective abdominal surgery. Br J Surg. 2007 Apr;94(4):421-6. doi: 10.1002/bjs.5631. |
| 22978458 | Background | de Brito Poveda V, Clark AM, Galvao CM. A systematic review on the effectiveness of prewarming to prevent perioperative hypothermia. J Clin Nurs. 2013 Apr;22(7-8):906-18. doi: 10.1111/j.1365-2702.2012.04287.x. Epub 2012 Sep 17. |
| Background | 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 |
| 11395189 | Background | Flores-Maldonado A, Medina-Escobedo CE, Rios-Rodriguez HM, Fernandez-Dominguez R. Mild perioperative hypothermia and the risk of wound infection. Arch Med Res. 2001 May-Jun;32(3):227-31. doi: 10.1016/s0188-4409(01)00272-7. |
| 10190363 | Background | Barone JE, Tucker JB, Cecere J, Yoon MY, Reinhard E, Blabey RG Jr, Lowenfels AB. Hypothermia does not result in more complications after colon surgery. Am Surg. 1999 Apr;65(4):356-9. |
| 20881777 | Background | Lehtinen SJ, Onicescu G, Kuhn KM, Cole DJ, Esnaola NF. Normothermia to prevent surgical site infections after gastrointestinal surgery: holy grail or false idol? Ann Surg. 2010 Oct;252(4):696-704. doi: 10.1097/SLA.0b013e3181f6c2a9. |
| 23787221 | Background | Pu Y, Cen G, Sun J, Gong J, Zhang Y, Zhang M, Wu X, Zhang J, Qiu Z, Fang F. Warming with an underbody warming system reduces intraoperative hypothermia in patients undergoing laparoscopic gastrointestinal surgery: a randomized controlled study. Int J Nurs Stud. 2014 Feb;51(2):181-9. doi: 10.1016/j.ijnurstu.2013.05.013. Epub 2013 Jun 17. |
| 21954692 | Background | Esnaola NF, Cole DJ. Perioperative normothermia during major surgery: is it important? Adv Surg. 2011;45:249-63. doi: 10.1016/j.yasu.2011.03.007. |
| 23989047 | Background | Melton GB, Vogel JD, Swenson BR, Remzi FH, Rothenberger DA, Wick EC. Continuous intraoperative temperature measurement and surgical site infection risk: analysis of anesthesia information system data in 1008 colorectal procedures. Ann Surg. 2013 Oct;258(4):606-12; discussion 612-3. doi: 10.1097/SLA.0b013e3182a4ec0f. |
| Surgery plan change after study approval |
|
| Lost to Follow-up |
|
| İnadequate data |
|
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
| BG002 | Total | Total of all reporting groups |
| Patients |
|
| Mean |
| Standard Deviation |
| years |
| Participants |
|
|
| Sex: Female, Male | For gender variable, groups were homogeneous. (p=0.190) | Count of Participants | Participants | Participants |
|
|
| BMI | For BMI variable, groups were homogeneous. (p=0.836) | Mean | Standard Deviation | kilograms per square meter | Participants |
|
|
| Weight | For weight variable, groups were homogeneous. (p=0.346) | Mean | Standard Deviation | kilograms | Participants |
|
|
| Height | For height variable, groups were homogeneous. (p=0.166) | Mean | Standard Deviation | centimeters | Participants |
|
|
| Ethiology | Etiologies including hepatopancreaticobiliary, colorectal, upper gastrointestinal systems diseases . | Count of Participants | Participants | Participants |
|
|
| Smoking habit | For smoking habit both groups were homogenous.(p=0.893) | Count of Participants | Participants | Participants |
|
|
| Alcohol Use | For alcohol use, groups were homogeneous. (p=0.541) | Count of Participants | Participants | Participants |
|
|
| Type of anesthesia | For anesthesia choice, groups were homogeneous. (p=0.655) | Count of Participants | Participants | Participants |
|
|
| Epidural catheter removal time if any inserted | For epidural catheher removal time, groups were homogeneous. (p=0.973) | For patients only had had epidural catheter inserted. | Mean | Standard Deviation | days | Participants |
|
|
| Central venous access | For cetral venous access choice groups were homogeneous. (p=0.107) | Count of Participants | Participants | Participants |
|
|
| If only temporary, removal time of central venous catheter | For temporary central venous catheter removing time both groups were homogenous. (p=0.259) | For patients only had had temporary central venous catheter inserted. | Mean | Standard Deviation | days | Participants |
|
|
| Operating Room Temperature | For operating room temperature variable, groups were homogeneous. (p=0.059) | Mean | Standard Deviation | ºC degrees | Patients |
|
|
| İntraoperative blood loss | For intraoperative blood loss data, groups were homogeneous. (p=0.614) | Mean | Standard Deviation | liters | Participants |
|
|
| İntraoperative red cell transfusion | For intraoperative red cell transfusion variable, groups were homogeneous. (p=0.470) | Mean | Standard Deviation | units | Participants |
|
|
| Intraoperative fresh frozen plasma transfusion | Mean | Standard Deviation | units | Participants |
|
|
| Intraoperative cristalloid fluid | For cristalloid fluid infusement amounts, groups were homogeneous. (p=0.855) | Mean | Standard Deviation | liters | Participants |
|
|
| Intraoperative colloid fluid | For colloid fluid infusement amounts, groups were homogeneous. (p=0.361) | Mean | Standard Deviation | liters | Participants |
|
|
| Intraoperative urine output | For peroperative urine output, groups were homogeneous. (p=0.559) | Mean | Standard Deviation | liters | Participants |
|
|
| Mean heart rate | For mean heart rate amounts, groups were homogeneous. (p=0.390) | Mean | Standard Deviation | beats per minute | Participants |
|
|
| Intraoperative mean arterial blood pressure | For intraoperative mean arterial blood pressure levels, groups were homogeneous. (p=0.388) | Mean | Standard Deviation | mm Hg | Participants |
|
|
| Operation duration | For operation duration , groups were homogeneous. (p=0.059) | Mean | Standard Deviation | minutes | Participants |
|
|
| Perioperative hemoglobin levels | Preoperative (p=0.984), postoperative first day (p=0.526) and ∆(Hemoglobin)(the difference between preoperative and postoperative first day levels)(p=0.385) | Mean | Standard Deviation | g/dl | Participants |
|
|
| Perioperative albumin levels | Preoperative (p=0.359), postoperative first day (p=0.314) and ∆(Albumin)(the difference between preoperative and postoperative first day levels)(p=0.055) | Mean | Standard Deviation | g/dl | Participants |
|
|
| Profilactic antibiotics | There were not enough numbers in all boxes so statistical analyses not appropriate to assess for this title. | Count of Participants | Participants | Participants |
|
|
| Duration of Hospitalization Parameters | 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). | In our study 11 patients from intervention group and 16 patients from control group needed ICU follow up after surgery. (p=0.348) | Mean | Standard Deviation | days | Participants |
|
| Simple Hospitalization costs | 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) | Mean | Standard Deviation | Thousand Turkish liras | Participants |
|
|
| Perioperative Warming | 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) | 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. | Number | participants | Participants |
|
| Surgical Site Classification | 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. | Count of Participants | Participants | Participants |
|
|
| ASA Score | 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) | Count of Participants | Participants | Participants |
|
|
| NNISS Score | 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. | Count of Participants | Participants | Participants |
|
|
| SENIC Score | 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) | Count of Participants | Participants | Participants |
|
|
| Comorbidities | 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. | Count of Participants | Participants | Participants |
|
|
| Perioperative Temperature Measurements | 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 | 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. | Mean | Standard Deviation | ºC degrees | Participants |
|
| Infectious Complications | Our study's main outcome which is SSI is significiantly different between two groups.(p=0.044) | Count of Participants | Participants | Participants |
|
|
| SSI Classification | Count of Participants | Participants | Participants |
|
|
| ASEPSIS Total Scores | 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.) | Mean | Standard Deviation | points | Participants |
|
|
| OG001 |
| 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 |
|
|
| 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) | Patients and their results assessed on the basis of intention to treat per protocole. | Posted | Count of Participants | Participants | Surgery day |
|
|
|
| 0 |
| 63 |
| 0 |
| 63 |
| EG001 | 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 | 0 | 55 | 1 | 55 |
Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| Upper Gastointestinal Tract |
|
| General and intrathecal anesthesia |
|
| Permenant central venous port previously inserted |
|
|
| ∆(Hemoglobin) |
|
|
| ∆(Albumin) |
|
| Title | Measurements |
|---|---|
|
| Ceftriaxone |
|
| Ceftriaxone+ metronidazole |
|
| Amoxicillin + clavulanate |
|
|
|
|
|
| Title | Measurements |
|---|---|
|
| Contaminated |
|
| ASA 3 |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
| Complicated Hypertension |
|
| Uncomplicated Hypertension |
|
| Chronic Respiratory Diseases |
|
| Uncomplicated Diabetes |
|
| Complicated Diabetes |
|
| Hypothyroidism |
|
| Lymphoma |
|
| Metastatic Cancer |
|
| Non-metastatic Solid Tumor |
|
| Other(Valvuler, collagen tissue, etc diseases) |
|
|
|
|
|
|
|
|
|
|
|
|
|
| Title | Measurements |
|---|---|
|
| Urinary |
|
| Bacteriemia |
|
| SSI |
|
| Title | Measurements |
|---|---|
|
| Organ-Space |
|