search
Back to results

Effect of Double Surgical Glove on Comfort, Sensitivity and Dexterity

Primary Purpose

Surgical Gloves

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Regular Size Glove and Bigger One
Sponsored by
Ankara Medipol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Surgical Gloves focused on measuring Surgical gloves, Comfort, Dexterity, Sensitivity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Taking part in the surgical team Six months or more of surgical experience Exclusion Criteria: Latex allergic

Sites / Locations

  • Neslihan Ilkaz

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Double Gloves:Regular Size

Double Gloves: Regular Size and Half-Size Bigger

Double Gloves: Half-Size Bigger and Regular Size

One Glove

Arm Description

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

Procedure B: Double gloves, Participants will wear their own glove size and half-size bigger glove on top

Procedure C: Double gloves, participants will wear a half-size big glove and their own glove size on top.

Procedure D: Participants will wear only one glove.

Outcomes

Primary Outcome Measures

Change from comfort, sensitivity, and dexterity after 90-120 min.
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).

Secondary Outcome Measures

Full Information

First Posted
September 5, 2023
Last Updated
October 15, 2023
Sponsor
Ankara Medipol University
search

1. Study Identification

Unique Protocol Identification Number
NCT06042088
Brief Title
Effect of Double Surgical Glove on Comfort, Sensitivity and Dexterity
Official Title
Comparison of the Effect of Glove Number on Comfort, Sensitivity, and Dexterity in the Use of Double Surgical Gloves
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 3, 2023 (Actual)
Primary Completion Date
October 15, 2023 (Actual)
Study Completion Date
November 3, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara Medipol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Gloves
Keywords
Surgical gloves, Comfort, Dexterity, Sensitivity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Double Gloves:Regular Size
Arm Type
Experimental
Arm Description
Procedure A: Double gloves, participants will wear both gloves in their surgical glove size.
Arm Title
Double Gloves: Regular Size and Half-Size Bigger
Arm Type
Experimental
Arm Description
Procedure B: Double gloves, Participants will wear their own glove size and half-size bigger glove on top
Arm Title
Double Gloves: Half-Size Bigger and Regular Size
Arm Type
Experimental
Arm Description
Procedure C: Double gloves, participants will wear a half-size big glove and their own glove size on top.
Arm Title
One Glove
Arm Type
No Intervention
Arm Description
Procedure D: Participants will wear only one glove.
Intervention Type
Other
Intervention Name(s)
Regular Size Glove and Bigger One
Intervention Description
Different sizes of surgical gloves will be worn by participants
Primary Outcome Measure Information:
Title
Change from comfort, sensitivity, and dexterity after 90-120 min.
Description
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).
Time Frame
After 90-120 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Taking part in the surgical team Six months or more of surgical experience Exclusion Criteria: Latex allergic
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neslihan Ilkaz
Organizational Affiliation
Ankara Medipol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neslihan Ilkaz
City
Ankara
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
22342011
Citation
Guo YP, Wong PM, Li Y, Or PP. Is double-gloving really protective? A comparison between the glove perforation rate among perioperative nurses with single and double gloves during surgery. Am J Surg. 2012 Aug;204(2):210-5. doi: 10.1016/j.amjsurg.2011.08.017. Epub 2012 Feb 17.
Results Reference
background
PubMed Identifier
19653826
Citation
Bouvet E, Pellissier G, Abiteboul D, L'Heriteau F; Group for the Prevention of Occupational Infections in Healthcare Workers. Is double gloving an effective barrier to protect surgeons against blood exposure due to needlestick injury? Infect Control Hosp Epidemiol. 2009 Sep;30(9):928-9; author reply 929. doi: 10.1086/599309. No abstract available.
Results Reference
background
PubMed Identifier
26306813
Citation
Schmauss D, Megerle K, Weinzierl A, Agua K, Cerny M, Schmauss V, Lohmeyer JA, Machens HG, Erne H. Microsurgeons do better--tactile training might prevent the age-dependent decline of the sensibility of the hand. J Peripher Nerv Syst. 2015 Dec;20(4):392-6. doi: 10.1111/jns.12144.
Results Reference
background
PubMed Identifier
27881806
Citation
Mylon P, Carre MJ, Martin N, Lewis R. How do gloves affect cutaneous sensibility in medical practice? Two new applied tests. Proc Inst Mech Eng H. 2017 Jan;231(1):28-39. doi: 10.1177/0954411916679199. Epub 2016 Nov 23.
Results Reference
background
Citation
8. World Health Organization (WHO), Global guidelines for the prevention of surgical site infection, 2nd ed.,2018. Erişim adresi: https://www.who.int/publications/i/item/global-guidelines-for-the-prevention-of-surgical-site-infection-2nd-ed
Results Reference
background
PubMed Identifier
33433290
Citation
Basak T, Sahin G, Demirtas A. Comparison of surgical gloves: perforation, satisfaction and manual dexterity. Int J Occup Saf Ergon. 2022 Jun;28(2):1160-1166. doi: 10.1080/10803548.2021.1875636. Epub 2021 Mar 2.
Results Reference
background
PubMed Identifier
23747130
Citation
Han CD, Kim J, Moon SH, Lee BH, Kwon HM, Park KK. A randomized prospective study of glove perforation in orthopaedic surgery: is a thick glove more effective? J Arthroplasty. 2013 Dec;28(10):1878-81. doi: 10.1016/j.arth.2013.05.007. Epub 2013 Jun 6.
Results Reference
background
PubMed Identifier
32904254
Citation
Moog P, Schulz M, Betzl J, Schmauss D, Lohmeyer JA, Machens HG, Megerle K, Erne HC. Do your surgical glove characteristics and wearing habits affect your tactile sensibility? Ann Med Surg (Lond). 2020 Aug 8;57:281-286. doi: 10.1016/j.amsu.2020.08.002. eCollection 2020 Sep. Erratum In: Ann Med Surg (Lond). 2021 Aug 21;69:102743.
Results Reference
background
PubMed Identifier
33733484
Citation
Zhang Z, Gao X, Ruan X, Zheng B. Effectiveness of double-gloving method on prevention of surgical glove perforations and blood contamination: A systematic review and meta-analysis. J Adv Nurs. 2021 Sep;77(9):3630-3643. doi: 10.1111/jan.14824. Epub 2021 Mar 17.
Results Reference
background

Learn more about this trial

Effect of Double Surgical Glove on Comfort, Sensitivity and Dexterity

We'll reach out to this number within 24 hrs