Effect of Standard Normothermia Protocol On Surgical Site Infections

NCT02961244 | Completed Results DMC

• 1 other identifier: 870-GOA
• Study Type: interventional
• Target: 118
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Surgical Site Infection

Keywords

Surgical Site Infection; normothermia; hypothermia; prewarming

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Maintaining Normothermia Rate

  Surgery day

Study Arms (2)

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.

Other: Prewarming and perioperative warming with Forced Air Warming device and its blankets.; Device: Forced Air Warming blanket

Interventions

Prewarming and perioperative warming with Forced Air Warming device and its blankets. OTHER

Intervention Group

Forced Air Warming blanket DEVICE

Intervention Group

Eligibility Criteria

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

You may qualify if:

• Elective
• Preoperatively not infected/dirty Surgical Site
• Open major abdominal operations (hepatobiliary, upper gastrointestinal or colorectal); under general anesthesia, longer than 30 minutes)

You may not qualify if:

• 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

Sponsors & Collaborators

• Dokuz Eylul University: lead

Related Publications (39)

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MeSH Terms

Conditions

Surgical Wound Infection; Hypothermia

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

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.

Results Point of Contact

• Title: Ali Kadir Degirmenci
• Organization: Dokuz Eylul University Medicine Faculty, General Surgery Department

alikadir@hotmail.com

+902324122901

Study Officials

• Mustafa Cem Terzi, Proffessor Doctor

  Dokuz Eylul School of Medicine, General Surgery, Colorectal and Pelvic Diseases Department

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asistant Investigator, MD

Study Record Dates

• First Submitted: November 1, 2016
• First Posted: November 10, 2016
• Study Start: June 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: June 1, 2016
• Last Updated: December 12, 2017
• Results First Posted: May 11, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will share