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| Name | Class |
|---|---|
| The Cleveland Clinic | OTHER |
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The purpose of this study is to determine:
Each patient will be randomly assigned to ambient temperature of 19°C, 21°C, or 23°C. Using a factorial approach, patients will also be randomly assigned to passive insulation or forced-air warming, stratified by the three types of surgery listed below. Group allocation will be based on computer generated codes (randomly permuted block sizes) prepared by Department of OUTCOMES RESEARCH statisticians using SAS statistical software. Allocation of consented patients to designated ambient temperature and forced-air vs. passive insulation will be via a web site that will be accessed by investigators in Bejing about 90 minutes before surgery.
Patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping. Patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface. A lower-body cover (about 91 by 221 cm) will be positioned so the lower end of the forced-air segments extend from the ankles upward for the entire length of the cover in thoracic and abdominal cases. The cover's foot drape will extend over the feet, and in turn be covered by the surgical drape. An upper-body forced-air cover will similarly be applied for patients having hip arthroplasties. The forced-air cover will be connected to a Bair Hugger blower and #635 covers set to "high" (≈43°C).
Ambient temperature will be adjusted to the designated temperature about an hour before a patient enters the operating room and adjusted as necessary to maintain the designated temperature throughout surgery. General anesthesia will be induced as per usual clinical routine. Neuraxial (epidural or spinal) and other regional blocks are permitted.
Any patients whose core temperature decreases to less than 34.5°C will be actively warmed with forced air and the ambient temperature increases to the extent practical.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ambient Temp 19°C & Passive Insulation | Experimental | Ambient Temperature 19°C and Passive Insulation: patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping. |
|
| Ambient Temp 19°C & Forced-air Warming | Experimental | Ambient Temperature 19°C and Forced-air Warming: patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface. |
|
| Ambient Temp 21°C & Passive Insulation | Experimental | Ambient Temperature 21°C and Passive Insulation: patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping. |
|
| Ambient Temp 21°C & Forced-air Warming | Experimental | Ambient Temperature 21°C and Forced-air Warming: patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ambient Temperature 19°C | Other | Ambient Temperature 19°C |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of Core Temperature Change | Rate of core temperature change from 1 to 3 hours after induction of anesthesia (°C/hour ) linear mixed-effects model to assess the effects of ambient temperature, forced-air warming and their interaction on the rate of core temperature change during 1 to 3h after induction | from 1 to 3 hours after induction of anesthesia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| LiJian Pei, MD | Associate Prof. of Dept. of Anesthesiology, PUMCH | Principal Investigator |
| Yuguang Huang, MD | Chair of Dept. of Anesthesiology, PUMCH | Study Chair |
| Daniel I Sessler, MD | Chair of Dept. of Outcomes Research, Anesthesiology Institute, Cleveland Clinic | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Anesthesiology, PUMCH | Beijing | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1610573 | Background | Hynson JM, Sessler DI. Intraoperative warming therapies: a comparison of three devices. J Clin Anesth. 1992 May-Jun;4(3):194-9. doi: 10.1016/0952-8180(92)90064-8. | |
| 18156884 | Background | Rajagopalan S, Mascha E, Na J, Sessler DI. The effects of mild perioperative hypothermia on blood loss and transfusion requirement. Anesthesiology. 2008 Jan;108(1):71-7. doi: 10.1097/01.anes.0000296719.73450.52. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ambient Temp 19°C & Passive Insulation | Ambient Temperature 19°C and Passive Insulation: patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping. Ambient Temperature 19°C: Ambient Temperature 19°C Passive insulation: Patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Ambient Temp 23°C & Passive Insulation | Experimental | Ambient Temperature 23°C and Passive Insulation: patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping. |
|
| Ambient Temp 23°C & Forced-air Warming | Experimental | Ambient Temperature 23°C and Forced-air Warming: patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface. |
|
| Ambient Temperature 21°C | Other | Ambient Temperature 21°C |
|
| Ambient Temperature 23°C | Other | Ambient Temperature 23°C |
|
| Forced-air cover (Bair hugger 63500, 3M) | Device | Patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface. |
|
| Passive insulation | Other | Patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping. |
|
| 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. |
| 9416715 | Background | Lenhardt R, Marker E, Goll V, Tschernich H, Kurz A, Sessler DI, Narzt E, Lackner F. Mild intraoperative hypothermia prolongs postanesthetic recovery. Anesthesiology. 1997 Dec;87(6):1318-23. doi: 10.1097/00000542-199712000-00009. |
| 7576669 | Background | Kurz A, Sessler DI, Narzt E, Bekar A, Lenhardt R, Huemer G, Lackner F. Postoperative hemodynamic and thermoregulatory consequences of intraoperative core hypothermia. J Clin Anesth. 1995 Aug;7(5):359-66. doi: 10.1016/0952-8180(95)00028-g. |
| 7486181 | Background | Matsukawa T, Sessler DI, Christensen R, Ozaki M, Schroeder M. Heat flow and distribution during epidural anesthesia. Anesthesiology. 1995 Nov;83(5):961-7. doi: 10.1097/00000542-199511000-00008. |
| 7879935 | Background | Matsukawa T, Sessler DI, Sessler AM, Schroeder M, Ozaki M, Kurz A, Cheng C. Heat flow and distribution during induction of general anesthesia. Anesthesiology. 1995 Mar;82(3):662-73. doi: 10.1097/00000542-199503000-00008. |
| 8342834 | Background | Hynson JM, Sessler DI, Moayeri A, McGuire J, Schroeder M. The effects of preinduction warming on temperature and blood pressure during propofol/nitrous oxide anesthesia. Anesthesiology. 1993 Aug;79(2):219-28, discussion 21A-22A. doi: 10.1097/00000542-199308000-00005. |
| 7576673 | Background | Camus Y, Delva E, Sessler DI, Lienhart A. Pre-induction skin-surface warming minimizes intraoperative core hypothermia. J Clin Anesth. 1995 Aug;7(5):384-8. doi: 10.1016/0952-8180(95)00051-i. |
| 7661349 | Background | Kurz A, Sessler DI, Christensen R, Dechert M. Heat balance and distribution during the core-temperature plateau in anesthetized humans. Anesthesiology. 1995 Sep;83(3):491-9. doi: 10.1097/00000542-199509000-00007. |
| 5091847 | Background | Roe CF. Effect of bowel exposure on body temperature during surgical operations. Am J Surg. 1971 Jul;122(1):13-5. doi: 10.1016/0002-9610(71)90338-2. No abstract available. |
| 10969294 | Background | Rajek A, Greif R, Sessler DI, Baumgardner J, Laciny S, Bastanmehr H. Core cooling by central venous infusion of ice-cold (4 degrees C and 20 degrees C) fluid: isolation of core and peripheral thermal compartments. Anesthesiology. 2000 Sep;93(3):629-37. doi: 10.1097/00000542-200009000-00010. |
| 1990897 | Background | Sessler DI, McGuire J, Moayeri A, Hynson J. Isoflurane-induced vasodilation minimally increases cutaneous heat loss. Anesthesiology. 1991 Feb;74(2):226-32. doi: 10.1097/00000542-199102000-00006. |
| 2021204 | Background | Sessler DI, McGuire J, Sessler AM. Perioperative thermal insulation. Anesthesiology. 1991 May;74(5):875-9. doi: 10.1097/00000542-199105000-00012. |
| 2382847 | Background | Sessler DI, Moayeri A. Skin-surface warming: heat flux and central temperature. Anesthesiology. 1990 Aug;73(2):218-24. |
| 8141463 | Background | Giesbrecht GG, Ducharme MB, McGuire JP. Comparison of forced-air patient warming systems for perioperative use. Anesthesiology. 1994 Mar;80(3):671-9. doi: 10.1097/00000542-199403000-00026. |
| 5100096 | Background | Morris RH. Influence of ambient temperature on patient temperature during intraabdominal surgery. Ann Surg. 1971 Feb;173(2):230-3. doi: 10.1097/00000658-197102000-00008. No abstract available. |
| 4250862 | Background | Morris RH. Operating room temperature and the anesthetized, paralyzed patient. Arch Surg. 1971 Feb;102(2):95-7. doi: 10.1001/archsurg.1971.01350020005002. No abstract available. |
| 5414287 | Background | Morris RH, Wilkey BR. The effects of ambient temperature on patient temperature during surgery not involving body cavities. Anesthesiology. 1970 Feb;32(2):102-7. doi: 10.1097/00000542-197002000-00003. No abstract available. |
| 18929769 | Background | Wang CS, Chen CL, Huang CJ, Cheng KW, Chen KH, Wang CC, Concejero AM, Cheng YF, Huang TL, Wang SH, Lin CC, Liu YW, Yong CC, Yang CH, Jawan B. Effects of different operating room temperatures on the body temperature undergoing live liver donor hepatectomy. Transplant Proc. 2008 Oct;40(8):2463-5. doi: 10.1016/j.transproceed.2008.07.077. |
| 15960641 | Background | Tander B, Baris S, Karakaya D, Ariturk E, Rizalar R, Bernay F. Risk factors influencing inadvertent hypothermia in infants and neonates during anesthesia. Paediatr Anaesth. 2005 Jul;15(7):574-9. doi: 10.1111/j.1460-9592.2005.01504.x. |
| 23340983 | Background | Ozer AB, Tosun F, Demirel I, Unlu S, Bayar MK, Erhan OL. The effects of anesthetic technique and ambient temperature on thermoregulation in lower extremity surgery. J Anesth. 2013 Aug;27(4):528-34. doi: 10.1007/s00540-013-1555-2. Epub 2013 Jan 23. |
| 20430151 | Background | Cheng KW, Wang CH, Chen CL, Jawan B, Wang CC, Concejero AM, Wang SH, Liu YW, Yong CC, Yang CH, Huang CJ. Decreased fresh gas flow cannot compensate for an increased operating room temperature in maintaining body temperature during donor hepatectomy for living liver donor hepatectomy. Transplant Proc. 2010 Apr;42(3):703-4. doi: 10.1016/j.transproceed.2010.02.065. |
| 1642343 | Background | Frank SM, Beattie C, Christopherson R, Norris EJ, Rock P, Parker S, Kimball AW Jr. Epidural versus general anesthesia, ambient operating room temperature, and patient age as predictors of inadvertent hypothermia. Anesthesiology. 1992 Aug;77(2):252-7. doi: 10.1097/00000542-199208000-00005. |
| 34858805 | Derived | Sun C, Gao H, Zhang Y, Pei L, Huang Y. Risk Stratification for Organ/Space Surgical Site Infection in Advanced Digestive System Cancer. Front Oncol. 2021 Nov 9;11:705335. doi: 10.3389/fonc.2021.705335. eCollection 2021. |
| FG001 | Ambient Temp 19°C & Forced-air Warming | Ambient Temperature 19°C and Forced-air Warming: patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface. Ambient Temperature 19°C: Ambient Temperature 19°C Forced-air cover (Bair hugger 63500, 3M): Patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface. |
| FG002 | Ambient Temp 21°C & Passive Insulation | Ambient Temperature 21°C and Passive Insulation: patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping. Ambient Temperature 21°C: Ambient Temperature 21°C Passive insulation: Patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping. |
| FG003 | Ambient Temp 21°C & Forced-air Warming | Ambient Temperature 21°C and Forced-air Warming: patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface. Ambient Temperature 21°C: Ambient Temperature 21°C Forced-air cover (Bair hugger 63500, 3M): Patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface. |
| FG004 | Ambient Temp 23°C & Passive Insulation | Ambient Temperature 23°C and Passive Insulation: patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping. Ambient Temperature 23°C: Ambient Temperature 23°C Passive insulation: Patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping. |
| FG005 | Ambient Temp 23°C & Forced-air Warming | Ambient Temperature 23°C and Forced-air Warming: patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface. Ambient Temperature 23°C: Ambient Temperature 23°C Forced-air cover (Bair hugger 63500, 3M): Patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ambient Temp 19°C & Passive Insulation | Ambient Temperature 19°C and Passive Insulation: patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping. Ambient Temperature 19°C: Ambient Temperature 19°C Passive insulation: Patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping. |
| BG001 | Ambient Temp 19°C & Forced-air Warming | Ambient Temperature 19°C and Forced-air Warming: patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface. Ambient Temperature 19°C: Ambient Temperature 19°C Forced-air cover (Bair hugger 63500, 3M): Patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface. |
| BG002 | Ambient Temp 21°C & Passive Insulation | Ambient Temperature 21°C and Passive Insulation: patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping. Ambient Temperature 21°C: Ambient Temperature 21°C Passive insulation: Patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping. |
| BG003 | Ambient Temp 21°C & Forced-air Warming | Ambient Temperature 21°C and Forced-air Warming: patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface. Ambient Temperature 21°C: Ambient Temperature 21°C Forced-air cover (Bair hugger 63500, 3M): Patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface. |
| BG004 | Ambient Temp 23°C & Passive Insulation | Ambient Temperature 23°C and Passive Insulation: patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping. Ambient Temperature 23°C: Ambient Temperature 23°C Passive insulation: Patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping. |
| BG005 | Ambient Temp 23°C & Forced-air Warming | Ambient Temperature 23°C and Forced-air Warming: patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface. Ambient Temperature 23°C: Ambient Temperature 23°C Forced-air cover (Bair hugger 63500, 3M): Patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Rate of Core Temperature Change | Rate of core temperature change from 1 to 3 hours after induction of anesthesia (°C/hour ) linear mixed-effects model to assess the effects of ambient temperature, forced-air warming and their interaction on the rate of core temperature change during 1 to 3h after induction | We plotted the mean core temperatures at 10-minute intervals. The trend of core temperature in each of the six groups between 1 to 3 hours was roughly linear. We thus used the slope (change in °C/hour) to characterize the rate sat which intraoperative core temperature changed. | Posted | Mean | Standard Deviation | degree C | from 1 to 3 hours after induction of anesthesia |
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1 month postoperatively
AKI, SSI
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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 | Ambient Temp 19°C & Passive Insulation | Ambient Temperature 19°C and Passive Insulation: patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping. Ambient Temperature 19°C: Ambient Temperature 19°C Passive insulation: Patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping. | 0 | 48 | 0 | 48 | 1 | 48 |
| EG001 | Ambient Temp 19°C & Forced-air Warming | Ambient Temperature 19°C and Forced-air Warming: patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface. Ambient Temperature 19°C: Ambient Temperature 19°C Forced-air cover (Bair hugger 63500, 3M): Patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface. | 0 | 50 | 0 | 50 | 1 | 50 |
| EG002 | Ambient Temp 21°C & Passive Insulation | Ambient Temperature 21°C and Passive Insulation: patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping. Ambient Temperature 21°C: Ambient Temperature 21°C Passive insulation: Patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping. | 0 | 49 | 0 | 49 | 1 | 49 |
| EG003 | Ambient Temp 21°C & Forced-air Warming | Ambient Temperature 21°C and Forced-air Warming: patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface. Ambient Temperature 21°C: Ambient Temperature 21°C Forced-air cover (Bair hugger 63500, 3M): Patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface. | 0 | 50 | 0 | 50 | 1 | 50 |
| EG004 | Ambient Temp 23°C & Passive Insulation | Ambient Temperature 23°C and Passive Insulation: patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping. Ambient Temperature 23°C: Ambient Temperature 23°C Passive insulation: Patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping. | 0 | 47 | 0 | 47 | 1 | 47 |
| EG005 | Ambient Temp 23°C & Forced-air Warming | Ambient Temperature 23°C and Forced-air Warming: patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface. Ambient Temperature 23°C: Ambient Temperature 23°C Forced-air cover (Bair hugger 63500, 3M): Patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface. | 0 | 48 | 0 | 48 | 2 | 48 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| surgical site infection | Infections and infestations | other | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel I. Sessler | Department of outcomes research Cleveland Ohio | ds@or.org |
| Male |
|