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The Effect of Using Double Gloves on Perforation in Orthopedic Surgery

NCT05928663 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1170

Last updated 2023-07-06

No results posted yet for this study

Summary

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.

Conditions

  • Puncture
  • Surgical Gloves
  • Orthopedic Disorder

Interventions

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

MEDI-GRIP® Latex Standard surgical gloves were included in the study as a single layer sterile surgical glove in the control group

Sponsors & Collaborators

  • Celal Bayar University

    lead OTHER

Principal Investigators

  • Hakan BAYDUR, Assoc. Prof. · Manisa Celal Bayar University, Faculty of Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-30
Primary Completion
2022-03-31
Completion
2022-07-18

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05928663 on ClinicalTrials.gov