The Effect of Using Double Gloves on Perforation in Orthopedic Surgery

NCT05928663 | Completed DMC

• 1 other identifier: MCBÜ-HulyaKizilTogac
• Study Type: interventional
• Target: 1,170
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Investigation of Perforations Presence of Gloves by Groups

  Whether there is a puncture (perforation) or not in intervention and control groups

  immediately after surgery

Study Arms (2)

double surgical gloves

EXPERIMENTAL

Other: double surgical gloves

single surgical gloves

OTHER

Other: single surgical gloves

Interventions

double surgical gloves OTHER

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

double surgical gloves

single surgical gloves OTHER

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

single surgical gloves

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celal Bayar University: lead

Study Sites (1)

Manisa Celal Bayar University Faculty of Health Sciences

Manisa, 45030, Turkey (Türkiye)

Location

Related Publications (27)

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  PMID: 30592511 BACKGROUND

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  PMID: 28320370 BACKGROUND

• de Barros MPM, Godoi TTF, Ferretti Filho M, Fernandes HJA, Dos Reis FB. Surgical Gloves in Orthopedic Trauma Procedures: How Many Lose Their Integrity? Rev Bras Ortop (Sao Paulo). 2021 Jun;56(3):379-383. doi: 10.1055/s-0040-1722591. Epub 2021 Jul 1.

  PMID: 34239206 BACKGROUND

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  PMID: 35695671 BACKGROUND

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  PMID: 26981792 BACKGROUND

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MeSH Terms

Conditions

Musculoskeletal Diseases

Interventions

Gloves, Surgical

Intervention Hierarchy (Ancestors)

Gloves, Protective; Protective Clothing; Personal Protective Equipment; Protective Devices; Equipment and Supplies; Surgical Attire; Surgical Equipment; Clothing; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Hakan BAYDUR, Assoc. Prof.

  Manisa Celal Bayar University, Faculty of Health Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: July 3, 2023
• Study Start: November 30, 2021
• Primary Completion: March 31, 2022
• Study Completion: July 18, 2022
• Last Updated: July 6, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)