Effect of Double Surgical Glove on Comfort, Sensitivity and Dexterity

Sponsor

Ankara Medipol University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT06042088

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

39.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This clinical trial aims to test the effect of double surgical gloves worn in different sizes on the surgical team's comfort, sensitivity, and dexterity.

Condition or Disease	Intervention/Treatment	Phase
Surgical Gloves	Other: Regular Size Glove and Bigger One	N/A

Detailed Description

The purpose of using surgical gloves is to create a protective barrier against blood-borne pathogens. According to studies, gloves can puncture during surgical procedures. Many studies recommend wearing double gloves. However, the World Health Organization reported that in the guideline for surgical site infections published in 2018, there is not enough evidence for wearing double or single gloves to prevent surgical site infections. However, he recommends that the surgical team prefer to use double gloves to protect themselves against punctures.

Although wearing double gloves is considered to be positive in terms of patient and employee safety, it is not preferred by the surgical team in some cases. The sense of touch and sensitivity of the human hand is at the center of surgical procedures. Finger pulp is extremely sensitive and contains many sensory receptors. Placing a barrier, such as a glove, between these sensory receptors and the touched surface may prevent tactile sensitivity in surgical applications. In addition to the advantages of double gloves in terms of patient and employee safety, there are disadvantages such as reduced dexterity and touch sensitivity. In the literature, it has been determined that there are few and old studies examining the effects of double glove use on performance and comfort. Therefore, this study, it was aimed to compare the effects of double surgical gloves worn in different procedures or usage habits (double gloves, large and small gloves) on the comfort, sensitivity, and dexterity of the surgical team.

The study will conduct as a prospective randomized controlled trial. After obtaining verbal and written consent from the participant, the study will conduct with various data collection forms. These forms are; the introductory information form, surgical glove evaluation form, and Visual Analogue Scale. Participants will randomize. After randomization, participants will be included in one of four groups. All procedures will be applied to participants in all groups. Group I (n=20), Group II (n=20), Group III (n=20), Group IV (n=20). Procedure A:

Double gloves, participants will wear both gloves in their surgical glove size. Procedure B:

Double gloves, participants will wear their own glove number and half a size bigger glove on top. Procedure C: Double gloves, participants will wear a half-size big glove and their own glove number on top. Procedure D: Participants will wear one glove (control procedure). Open surgeries with a duration of 90-120 minutes will be preferred for evaluation.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Comparison of the Effect of Glove Number on Comfort, Sensitivity, and Dexterity in the Use of Double Surgical Gloves

Actual Study Start Date :

Sep 3, 2023

Anticipated Primary Completion Date :

Oct 3, 2023

Anticipated Study Completion Date :

Nov 3, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Double Gloves:Regular Size Procedure A: Double gloves, participants will wear both gloves in their surgical glove size.	Other: Regular Size Glove and Bigger One Different sizes of surgical gloves will be worn by participants
Experimental: Double Gloves: Regular Size and Half-Size Bigger Procedure B: Double gloves, Participants will wear their own glove size and half-size bigger glove on top	Other: Regular Size Glove and Bigger One Different sizes of surgical gloves will be worn by participants
Experimental: Double Gloves: Half-Size Bigger and Regular Size Procedure C: Double gloves, participants will wear a half-size big glove and their own glove size on top.	Other: Regular Size Glove and Bigger One Different sizes of surgical gloves will be worn by participants
No Intervention: One Glove Procedure D: Participants will wear only one glove.

Outcome Measures

Primary Outcome Measures

Change from comfort, sensitivity, and dexterity after 90-120 min. [After 90-120 minutes]
In this section, the degree of comfort, sensitivity, and dexterity. This status will be evaluated with Visual Analogue Scale. In Visual Analogue Scale we use between 0-10 point (0= most uncomfortable/ most insensitivity/ most indexterity, 10=most comfort/ most sensitivity/ most dexterity).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Taking part in the surgical team Six months or more of surgical experience

Exclusion Criteria:

Latex allergic

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Neslihan Ilkaz	Ankara		Turkey

Sponsors and Collaborators

Ankara Medipol University

Investigators

Principal Investigator: Neslihan Ilkaz, Ankara Medipol University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Neslihan Ilkaz, Assistant Professor, Ankara Medipol University

ClinicalTrials.gov Identifier:

NCT06042088

Other Study ID Numbers:

2023/170

First Posted:

Sep 18, 2023

Last Update Posted:

Sep 18, 2023

Last Verified:

Sep 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Neslihan Ilkaz, Assistant Professor, Ankara Medipol University

Additional relevant MeSH terms:

Hypersensitivity

Study Results

No Results Posted as of Sep 18, 2023