Evaluation of the Effect of Surgical Drapes on Intraoperative Hypothermia

April 6, 2022 updated by: Neslihan Ilkaz
This study was planned to investigate whether the wetness of surgical drapes (disposable and resusable drapes) used in the intraoperative period causes hypothermia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After being informed about the study and potential risk all patients giving written informed consent then the study started. Patients who will undergo elective, gastrointestinal and other major abdominal surgery were included in the study. After patients were randomized by the investigator, patients were covered with disposable or reusable surgical drapes in accordance with hospital procedure. The body temperatures of the patients were followed for 2-6 hours as tympanic and esophageal. In addition, pre- and postoperative surgical drapes, sponges, compresses were measured with precision scales.

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Keçiören
      • Ankara, Keçiören, Turkey, 06010
        • Gulhane Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA 1-2-3
  • Patients with abdominal surgery
  • Patients receiving general anesthesia

Exclusion Criteria:

  • Unwanted to participate in the study
  • Patients over 70 years of age
  • Presence of central (high) fever originating from the central nervous system resulting from conditions such as cerebrovascular disease, cerebral trauma, intracranial surgery, epilepsy or acute hydrocephalus
  • Abnormalities of thermoregulation such as hypothyroidism, hyperthyroidism, history of malignant hyperthermia, or neuroleptic malignant syndrome
  • Presence of infectious fever
  • ASA 4 and above
  • Emergency surgery
  • Patients receiving pre-operative chemotherapy
  • Having problems such as tearing and perforation of the covers during the work.
  • Patients being hyperthermic in the intraoperative process

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Disposable Drapes
group using disposable surgical drapes
Other: Disposable Drape
Disposable surgical drapes, consisting of 6 pieces, were used as a set during surgery
Other: Reusable Drapes
group using reusable surgical drapes
Other: Reusable Drape
Reusable surgical drapes, consisting of 6 pieces, were used as a set during surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tympanic and esophageal body temperature measurement between two groups
Time Frame: throughout the operation (min.2 hours) (max. 6 hours)
Tympanic and esophageal body temperature measurement between the two groups was followed throughout the operation.
throughout the operation (min.2 hours) (max. 6 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neslihan Ilkaz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Actual)

November 30, 2020

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

March 21, 2022

First Submitted That Met QC Criteria

March 21, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Actual)

April 14, 2022

Last Update Submitted That Met QC Criteria

April 6, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Interventional (Oncolys BioPharma Inc)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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