The Effect of Using Double Gloves on Perforation in Orthopedic Surgery

July 3, 2023 updated by: Hülya Kızıl Toğaç, Celal Bayar University

The Effect on Puncture of the Use of Double Gloves in Orthopedic Surgery

Aim: This study aimed to investigate the effect of using double gloves on perforation in orthopedic surgery.

Materials and Method: The randomized controlled experimental study was conducted between 30.11.2021 and 31.03.2022 in the Orthopedics and Traumatology operating room of a university hospital in western Turkey. The gloves used in the surgery were randomly divided into two groups (intervention: double glove group = 780 gloves, control: single glove group = 390). The presence of holes was checked by performing a water tightness test with the EN455-1 method on all gloves collected after the surgery by the researcher. Data were evaluated with descriptive statistics, Chi-square Test, Fisher Exact Test, and linear model regression analysis (GLM for the Binomial Family Regression). Statistical significance was accepted as 0.05.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The sample size of the study was calculated based on the work of Makama et al. In the study, the perforation rate of the single glove was 15.2% and the perforation rate of the second glove in the double glove was determined as 1.17%. Considering these values, the number of gloves to be included in the intervention and control groups (in the single and double glove groups) was calculated as 249, with a 99% confidence interval (α=0.001) and 99% power in the NCSS PASS program. The total number of gloves planned to be evaluated in the intervention (double glove group, 249x2=498) and control (single glove group, 249) groups was determined as 747. The study included a total of 1170 gloves, with 780 gloves in the intervention group and 390 gloves in the control group. The allocation of gloves to the groups was determined using block randomization. The block size of 4 was selected, and all possible permutations of allocation within the block were computed. Blocks were then randomly selected to indicate the allocation of gloves to the intervention or control group.

Data Collection Tools

Patient and Surgery Information Form: In this form, which was created by examining the researches on glove perforations, there are 13 questions consisting of information about the patient, information about the surgical procedure and information about the surgical team.

Gloves Information Form: In this form, which was prepared by examining the literature, there are 16 questions such as the type of glove collected after the surgery, the team member using the glove, the dominant hand of the person using the glove, the duration of experience, the use of cement in the surgery, the time and reasons for replacing the gloves, the perforation conditions, the areas where the perforations are located Interventions Before the research, the necessary approval (Reference number: 20.05.2020/20.478.486) was obtained from the university clinical ethics committee, and the research was performed according to the principles of the Helsinki Declaration. Orthopedic surgeries other than soft tissue surgeries were included in the study.

When the patient was admitted to the operating room, the section containing the patient's information was filled out by using the patient file. On the same form, it was filled in the section containing the information about the surgical team and recorded in the form. In the intervention group, the surgical team members wore brown colored ENCORE® Latex Micro as the inner glove, while white MEDI-GRIP® Latex Standard was used as the outer glove. In the control group, only MEDI-GRIP® Latex Standard gloves were worn. All information about the gloves used in the surgery was recorded in the forms prepared by the researcher. In these forms, the team member who used the gloves, if the gloves were changed, the reason for the change and the time of replacement were stated. Making the surgical incision was defined as the beginning of the operation and the end of the operation when the incision was closed and all surgical instruments were removed from the patient. The time between the beginning and the end of the surgery in minutes was recorded on the form. The number of single and double gloves used during the surgery, the duration of the surgery and the cutting and piercing rotary devices and tools that may affect the perforations were also recorded on the forms. During the operation, the members of the surgical team were constantly monitored by the researcher. In cases where glove change was made, the reason and time of glove change were recorded by the researcher. The gloves used were placed in boxes with barcodes before hand.

All gloves collected after the surgery were tested by the researcher by standardized water leak method EN 455-1. In this method, which was applied to determine the perforation status in the gloves, 1000±50 ml of tap water was filled into the gloves. The temperature of the water was between 15-35°C. Gloves filled with water were observed for two minutes. The area where the water leak occurred was marked on the form and recorded. All fingers were lettered, starting with the little finger of the left hand, in order to more easily register the perforation areas in the gloves (left pinky: a, right pinky: j, left back: k, right back: l, left palm: m, and right palm: n). The perforations detected during the water tightness control were recorded in this order. The same test was applied to the gloves that were opened and not used for control purposes at the beginning of each operation. In the study, double gloves were worn in 55 operations in the intervention group, while single gloves were worn in 57 operations in the control group. Gloves of the same brand, which were opened on the operating table but never used, were checked for each operation. No perforations were detected total of 334 in these gloves that 220 (inner gloves 55x2=110; outer gloves 55x2=110) in the intervention group and 114 (57x2=114) in the control group. Although the number of people in the surgical team during the operation was not standard, there was definitely a surgeon and a nurse in the team. The water leak test applied to collect the gloves used after the surgery and to detect the perforations was performed by the same researcher. However, the same person who was a nurse among the surgical team members during the water leak test of all gloves was present as an observer at the time of the test.

Study Type

Interventional

Enrollment (Actual)

1170

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
      • Manisa, Turkey, 45030
        • Manisa Celal Bayar University Faculty of Health Sciences

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • In the intervention group, ENCORE® Latex Micro was used as the inner glove and MEDI-GRIP® Latex Standard was used as the outer glove
  • MEDI-GRIP® Latex Standard gloves were used in the control group.

Exclusion Criteria:

  • Gloves that were removed before the operation starts in cases where the surgical team member's glove is torn or contaminated for any reason.
  • Gloves worn by the surgical team member after changing gloves for any reason.
  • Gloves worn by the replacement person in cases where the surgical team members leave their place to another team member for any reason.

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: double surgical gloves
Other: double surgical gloves
In the intervention group, the surgical team members wore brown colored ENCORE® Latex Micro as the inner glove, while white MEDI-GRIP® Latex Standard was used as the outer glove
Other: single surgical gloves
Other: single surgical gloves
MEDI-GRIP® Latex Standard surgical gloves were included in the study as a single layer sterile surgical glove in the control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigation of Perforations Presence of Gloves by Groups
Time Frame: immediately after surgery
Whether there is a puncture (perforation) or not in intervention and control groups
immediately after surgery

Collaborators and Investigators

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

Sponsor

Celal Bayar University

Investigators

  • Study Chair: Hakan BAYDUR, Assoc. Prof., Manisa Celal Bayar University, Faculty of Health Sciences

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)

November 30, 2021

Primary Completion (Actual)

March 31, 2022

Study Completion (Actual)

July 18, 2022

Study Registration Dates

First Submitted

June 14, 2023

First Submitted That Met QC Criteria

June 23, 2023

First Posted (Actual)

July 3, 2023

Study Record Updates

Last Update Posted (Actual)

July 6, 2023

Last Update Submitted That Met QC Criteria

July 3, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCBÜ-HulyaKizilTogac

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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