Effect of Active Warming on Surgical Site Infections

NCT04187378 | Unknown DMC FDA Device

• 1 other identifier: 31102019-15/III
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effect of active warming by maintaining the normothermia during abdominal surgical procedures. The investigators hypothesize that there is no difference in terms of preventing surgical site infections between warm air blown surgical access blanket and underbody blanket.

Conditions

Surgical Site Infection; Ventral Hernia

Keywords

Hypothermia; Surgical Wound Infection; Herniorrhaphy; Nursing care

Outcome Measures

Primary Outcomes (1)

• Surgical Site Infection Rate

  The rate of surgical site infection will be monitored for each group by the case doctor and principle investigator. The patients will be diagnosed as Surgical Site Infection (SSI) according to CDC Guidelines if there is purulent wound drainage or serous but wound culture is positive within the postoperative 30 days.

  Within the postoperative 30 days

Secondary Outcomes (2)

• Body Temperature

  During the surgery and 2 hours after surgery (up to 300 minutes)

• Duration of surgery

  Day 0 (day of surgery)

Study Arms (3)

Control Group

NO INTERVENTION

Body temperature of the patients will be measured in the pre-operative service and in the waiting room. Sociodemographic characteristics form, preoperative, intra and postoperative evaluation forms will be completed. Body temperature, blood pressure, respiratory rate, heart rate and O2 saturation of the patients will be monitored every 15 minutes during the operation and postoperative 2 hours and data will be recorded on the data collection form.

Underbody Blanket Group

EXPERIMENTAL

Patients with hypothermia (\<36C) will be warmed by air blown underbody blanket before the surgical procedure. Warming procedure will be continued during and postoperative 2 hours of surgery. Body temperature will be measured by tympanic temperature gauge. Intravenous fluid, antiseptic solutions and irrigation fluids will be given to the patients during surgery by heating before administering. Body temperature, blood pressure, respiratory rate, heart rate and O2 saturation of the patients will be monitored every 15 minutes during the operation and postoperative 2 hours and data will be recorded on the data collection form.

Device: Surgical Underbody Blanket

Surgical Access Blanket Group

EXPERIMENTAL

Patients with hypothermia (\<36C) will be warmed by air blown surgical access blanket before the surgical procedure. Warming procedure will be continued during and postoperative 2 hours of surgery. Body temperature will be measured by tympanic temperature gauge. Intravenous fluid, antiseptic solutions and irrigation fluids will be given to the patients during surgery by heating before administering. Body temperature, blood pressure, respiratory rate, heart rate and O2 saturation of the patients will be monitored every 15 minutes during the operation and postoperative 2 hours and data will be recorded on the data collection form.

Device: Surgical access blanket

Interventions

Surgical Underbody Blanket DEVICE

Surgical blanket is used to maintain normothermia during abdominal surgery

Underbody Blanket Group

Surgical access blanket DEVICE

Surgical blanket is used to maintain normothermia during abdominal surgery

Surgical Access Blanket Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with American Society of Anesthesiologists score I-II-III,
• years old,
• Patients undergoing abdominal surgery (ventral hernia)
• Patients whose operation lasts longer than 30 minutes and less than 3 hours

You may not qualify if:

• Patients with American Society of Anesthesiologists score IV-V
• Patients with morbid obese (BMI\> 40kg / m\^2)
• Patients with neurological, psychiatric, neuromuscular disease
• Alcohol and drug addict patients
• Mental retarded patients
• Patients taking medications that affect thermoregulation, such as vasodilators
• Patients with a history of thyroid disease
• Pregnant women
• Patients undergoing pre-intra-post-blood transfusion
• Patients with blood glucose levels above 200 mg / dl

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Muğla Sıtkı Koçman University Training and Research Hospital

Muğla, Turkey (Türkiye)

RECRUITING

Related Publications (10)

• Batsis JA, Naessens JM, Keegan MT, Huddleston PM, Wagie AE, Huddleston JM. Body mass index and the impact on hospital resource use in patients undergoing total knee arthroplasty. J Arthroplasty. 2010 Dec;25(8):1250-7.e1. doi: 10.1016/j.arth.2009.09.009. Epub 2010 Feb 19.

  PMID: 20171045 BACKGROUND

• Bender M, Self B, Schroeder E, Giap B. Comparing new-technology passive warming versus traditional passive warming methods for optimizing perioperative body core temperature. AORN J. 2015 Aug;102(2):183.e1-8. doi: 10.1016/j.aorn.2015.06.005.

  PMID: 26227528 BACKGROUND

• Cooper S. The effect of preoperative warming on patients' postoperative temperatures. AORN J. 2006 May;83(5):1073-6, 1079-84; quiz 1085-8. doi: 10.1016/s0001-2092(06)60118-x.

  PMID: 16722285 BACKGROUND

• Deren ME, Machan JT, DiGiovanni CW, Ehrlich MG, Gillerman RG. Prewarming operating rooms for prevention of intraoperative hypothermia during total knee and hip arthroplasties. J Arthroplasty. 2011 Dec;26(8):1380-6. doi: 10.1016/j.arth.2010.12.019. Epub 2011 Feb 12.

  PMID: 21316914 BACKGROUND

• Hart SR, Bordes B, Hart J, Corsino D, Harmon D. Unintended perioperative hypothermia. Ochsner J. 2011 Fall;11(3):259-70.

  PMID: 21960760 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.

  PMID: 1610573 BACKGROUND

• Marino M, Masella R, Bulzomi P, Campesi I, Malorni W, Franconi F. Nutrition and human health from a sex-gender perspective. Mol Aspects Med. 2011 Feb;32(1):1-70. doi: 10.1016/j.mam.2011.02.001. Epub 2011 Feb 26.

  PMID: 21356234 BACKGROUND

• Savage JW, Anderson PA. An update on modifiable factors to reduce the risk of surgical site infections. Spine J. 2013 Sep;13(9):1017-29. doi: 10.1016/j.spinee.2013.03.051. Epub 2013 May 24.

  PMID: 23711958 BACKGROUND

• Sessler DI. Mild perioperative hypothermia. N Engl J Med. 1997 Jun 12;336(24):1730-7. doi: 10.1056/NEJM199706123362407. No abstract available.

  PMID: 9180091 BACKGROUND

• Gustafsson UO, Scott MJ, Hubner M, Nygren J, Demartines N, Francis N, Rockall TA, Young-Fadok TM, Hill AG, Soop M, de Boer HD, Urman RD, Chang GJ, Fichera A, Kessler H, Grass F, Whang EE, Fawcett WJ, Carli F, Lobo DN, Rollins KE, Balfour A, Baldini G, Riedel B, Ljungqvist O. Guidelines for Perioperative Care in Elective Colorectal Surgery: Enhanced Recovery After Surgery (ERAS(R)) Society Recommendations: 2018. World J Surg. 2019 Mar;43(3):659-695. doi: 10.1007/s00268-018-4844-y.

  PMID: 30426190 BACKGROUND

Related Links

• The Essentials of Maintaining Patient Normothermia
• Peri-operative hypothermia: implications for practice
• Surgical site infections: prevention and treatment

MeSH Terms

Conditions

Surgical Wound Infection; Hernia, Ventral; Hypothermia

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Body Temperature Changes; Signs and Symptoms

Study Officials

• İkbal Çavdar, Professor

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

Central Study Contacts

Cemile Çelebi, M.Sc.

CONTACT

+905547276385; ccelebi48@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Randomized controlled study

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: December 5, 2019
• Study Start: February 10, 2020
• Primary Completion: August 11, 2022
• Study Completion: December 1, 2022
• Last Updated: April 1, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)