Ignite Creation Date:
2024-05-06 @ 9:56 AM
Last Modification Date:
2024-10-26 @ 12:22 PM
Study NCT ID:
NCT03119389
Status:
COMPLETED
Last Update Posted:
2020-05-19
First Post:
2017-03-30
Brief Title:
Direct Gloving Strategy A Cluster-randomized Trial
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Efficacy of a Direct Gloving Strategy to Improve Compliance With Infection Prevention Practices A Cluster-randomized Trial
Status:
COMPLETED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The necessity of Hand hygiene HH before donning non-sterile gloves is unknown Furthermore because of the additional time required to cleanse hands and then don gloves as well as the cumbersome nature of applying gloves to recently washed hands this practice leads to non-compliance with both HH and glove use - placing patients at risk In a pilot study the investigators performed a randomized trial of 230 healthcare workers and demonstrated no difference in total bacterial colony counts or identification of pathogenic bacteria from the gloves of persons who either performed HH or did not perform HH prior to putting on non-sterile gloves If unnecessary HH before non-sterile glove use wastes valuable time which might otherwise be spent engaged in direct patient care And removing this unnecessary step may lead to increased compliance with infection prevention measures In Aim A the investigators will perform a multi-center randomized control trial to evaluate the efficacy of a direct gloving strategy to improve compliance with infection prevention practices In Aim B the investigators will perform a nested multi-center validation study where the gloved hands of healthcare workers will be randomly sampled to determine bacterial contamination of non-sterile gloves after donning
Detailed Description:
This study seeks to investigate alternative strategies to hand hygiene HH and glove use in situations where glove use is required to perform health care activities in an effort to increase compliance with infection prevention efforts
HH is the cornerstone of infection prevention Despite the importance of and increased focus on HH compliance remains low in healthcare settings 40 on average in a large meta-analysis Insufficient time high workload and under staffing are important barriers Glove use which is common and increasing is another major barrier New strategies are needed that improve time and efficiency particularly in settings where glove use is required eg Contact Precautions One area for further study is the requirement for HH prior to non-sterile glove use This is a recommended practice with poor compliance that may be unnecessary Furthermore it may lead to reduced compliance with other recommended infection prevention practices such as glove use In this proposal the investigators identify a novel strategy of directly gloving without performing HH prior to non-sterile glove use as a potential solution
In this study the investigators aim to perform a multicenter cluster-randomized trial to evaluate the efficacy of direct gloving to improve compliance with infection prevention practices ie HH and glove use Herein the investigators will evaluate the safety and efficacy of directly gloving compared to performing HH prior to glove use and assess whether this strategy will lead to increased compliance with both HH and glove use The investigators previously demonstrated the safety of this strategy in a single-center randomized controlled pilot trial where the investigators found no difference in bacterial contamination of gloves of healthcare providers who either performed or did not perform HH prior to donning non-sterile gloves Thus with potentially no added benefit and in a setting where the investigators know that HH compliance is the lowest ie prior to glove use mandating HH prior to donning gloves as recommended in current guidelines could actually reduce both HH and glove compliance placing patients at increased risk for developing infection
HH is the cornerstone of infection prevention Despite the importance of and increased focus on HH compliance remains low in healthcare settings 40 on average in a large meta-analysis Insufficient time high workload and under staffing are important barriers Glove use which is common and increasing is another major barrier New strategies are needed that improve time and efficiency particularly in settings where glove use is required eg Contact Precautions One area for further study is the requirement for HH prior to non-sterile glove use This is a recommended practice with poor compliance that may be unnecessary Furthermore it may lead to reduced compliance with other recommended infection prevention practices such as glove use In this proposal the investigators identify a novel strategy of directly gloving without performing HH prior to non-sterile glove use as a potential solution
In this study the investigators aim to perform a multicenter cluster-randomized trial to evaluate the efficacy of direct gloving to improve compliance with infection prevention practices ie HH and glove use Herein the investigators will evaluate the safety and efficacy of directly gloving compared to performing HH prior to glove use and assess whether this strategy will lead to increased compliance with both HH and glove use The investigators previously demonstrated the safety of this strategy in a single-center randomized controlled pilot trial where the investigators found no difference in bacterial contamination of gloves of healthcare providers who either performed or did not perform HH prior to donning non-sterile gloves Thus with potentially no added benefit and in a setting where the investigators know that HH compliance is the lowest ie prior to glove use mandating HH prior to donning gloves as recommended in current guidelines could actually reduce both HH and glove compliance placing patients at increased risk for developing infection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None