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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

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.

Condition or disease Intervention/treatment Phase
Surgical Site Infection Other: Prewarming and perioperative warming with Forced Air Warming device and its blankets. Device: Forced Air Warming blanket Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Standard Normothermia Protocol On Surgical Site Infections: Randomized Controlled Trial
Study Start Date : June 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : June 2016

Arm Intervention/treatment
No Intervention: Control Group
Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming.
Active Comparator: Intervention Group
Perioperative management and warming was performed according to a standard normothermia protocol with active prewarming.
Other: Prewarming and perioperative warming with Forced Air Warming device and its blankets.
Device: Forced Air Warming blanket



Primary Outcome Measures :
  1. Surgical Site Infection Rate [ Time Frame: 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 Outcome Measures :
  1. Maintaining Normothermia Rate [ Time Frame: 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)




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02961244


Sponsors and Collaborators
Dokuz Eylul University
Investigators
Study Director: Mustafa Cem Terzi, Proffessor Doctor Dokuz Eylul School of Medicine, General Surgery, Colorectal and Pelvic Diseases Department

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, Asistant Investigator, MD, Dokuz Eylul University
ClinicalTrials.gov Identifier: NCT02961244     History of Changes
Other Study ID Numbers: 870-GOA
First Posted: November 10, 2016    Key Record Dates
Results First Posted: May 11, 2017
Last Update Posted: December 12, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Ali Kadir Değirmenci, Dokuz Eylul University:
Surgical Site Infection
normothermia
hypothermia
prewarming

Additional relevant MeSH terms:
Infection
Communicable Diseases
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes