NCT04187378

Effect of Active Warming on Surgical Site Infections

The Effect of Maintenance of Normothermia With Active Warming on Surgical Site Infections in Patients Undergoing Abdominal Surgery

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Istanbul University - Cerrahpasa · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Hypothermia is defined as a body temperature below 36°C and classified as mild (34°C-36°C), moderate (32°C-33.9°C), severe (\<32°C) hypothermia. Hypothermia can be caused by reduced heat production, increased heat loss and / or deterioration of thermoregulation (anesthesia and premedication drugs, antiseptic solutions, low ambient temperature, wet surgical sterile drapes on the patient, use of cold intravenous fluids). Preoperative, intraoperative and postoperative hypothermia is the drop of body temperature below 36 ° C within one hour before surgery and within 24 hours postoperatively. It is the most common but preventable thermal disorder during anesthesia. It occurs as a result of anesthesia on thermoregulation during surgery and exposure to cold operating room. Although it can be seen in all anesthetized individuals before, during and after surgery due to age, sex, body surface area and body shape; duration, depth, signs and symptoms may vary. The American Society of Operating Room Nurses (AORN) emphasized the importance of the use of appropriate heating devices in the prevention of hypothermia in surgical patients. Experimental studies and meta-analyzes indicate that active methods of preventing hypothermia (hot air blown systems, hot water circulating blankets and garments, liquid heaters, blood and blood product heaters, etc.), passive methods (wool and synthetic woolen materials, garments and blankets, insulation) materials, etc.) are more effective. It is recommended to use more than one method together to maintain normothermia before, during and after surgery. Hypothermia is an important problem that should be prevented in surgical patient because it causes serious problems such as delayed wound healing, bleeding, cardiac problems, deterioration of patient comfort, prolonged hospital stay, surgical site infection (SSI) and deaths. Many guidelines state that the risk of surgical site infection increases three fold due to a decrease in central temperature of 1.9 C. According to the Guidelines for Safe Surgery published by the World Health Organization in 2009; maintaining normothermia during surgery is one of the ten steps intended to reduce the incidence of postoperative surgical site infection. The National Institute for Health and Care Excellence and the Association for Enhanced Recovery After Surgery (ERAS) recommend the maintenance of intraoperative normothermia to prevent surgical site infection. Surgical nurse; should be aware of the causes of hypothermia and the complications that may occur during the planning, implementation and evaluation of a patient-specific, multi-faceted care; should check the body temperature before, during and after surgery and take precautions to prevent body temperature. Therefore, the body temperature of the patient should be monitored at regular intervals, the body temperature of the preventive interventions must be timely and effective implementation. The maintenance of normothermia in patients with perioperative procedures may reduce the incidence of complications due to hypothermia and may have a positive effect on the success and recovery of surgery.

Conditions

• Surgical Site Infection
• Ventral Hernia

Interventions

Type	Name	Description
DEVICE	Surgical Underbody Blanket	Surgical blanket is used to maintain normothermia during abdominal surgery
DEVICE	Surgical access blanket	Surgical blanket is used to maintain normothermia during abdominal surgery

Timeline

• Start date: 2020-02-10
• Primary completion: 2022-08-11
• Completion: 2022-12-01
• First posted: 2019-12-05
• Last updated: 2022-04-01

Locations

1 site across 1 country: Turkey (Türkiye)

Regulatory

• FDA-regulated device study