Trial · NCT03119389
Direct Gloving Strategy: A Cluster-randomized Trial
NCT03119389, Not applicable, Completed, University of Maryland, Baltimore; results first posted 2020-05-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Direct Gloving Strategy: A Cluster-randomized Trial. Trials, record NCT03119389. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03119389
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Direct Gloving Strategy: A Cluster-randomized Trial
- NCT number
- NCT03119389
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 14,418 participants, actual
- Lead sponsor
- University of Maryland, Baltimore
- Conditions
- Hand Hygiene
- Interventions
- Donning Non-Sterile Gloves without HH
- First posted
- 2017-04-18
- Last updated
- 2020-05-19
- Results first posted
- 2020-05-19
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Composite Compliance With Expected Infection Prevention Practices Upon Entry to Contact Precaution-patient Rooms | 1 year | Healthcare workers in the usual care group will be recorded as compliant if hand hygiene AND glove use is observed at room entry; healthcare workers in the intervention group only need to have glove use observed to be considered compliant. |
| Secondary | Proportion of Healthcare Worker Who Use Glove on Entry Into Contact Precaution Rooms | 1 year | Proportion of healthcare worker compliance with glove use upon entry to Contact Precaution-patient rooms for both groups |
| Secondary | Proportion of Healthcare Workers Who Perform Hand Hygiene on Entry Into Non-contact Precaution Room | 1 year | Proportion of healthcare worker compliance with hand hygiene upon entry into non-contact precaution patient rooms |
| Secondary | Proportion of Healthcare Worker Who Perform Hand Hygiene on Exit From Any Room | 1 year | Proportion of healthcare worker compliance with hand hygiene upon exit from any patient room |
| Other | Mean Total Bacterial Colony Count | 1 year | Mean bacterial colony count from gloves of healthcare workers in the intervention and control units |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Composite Compliance With Expected Infection Prevention Practices Upon Entry to Contact Precaution-patient Rooms | 1 year | The number analyzed is the number of observations made within each group of units randomized | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Healthcare Worker Who Use Glove on Entry Into Contact Precaution Rooms | 1 year | The number analyzed is the number of observations made within each group of units randomized | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Healthcare Workers Who Perform Hand Hygiene on Entry Into Non-contact Precaution Room | 1 year | The number analyzed is the number of observations made within each group of units randomized | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Healthcare Worker Who Perform Hand Hygiene on Exit From Any Room | 1 year | The number analyzed is the number of observations made within each group of units randomized | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Mean Total Bacterial Colony Count | 1 year | The number analyzed is the number of observations made within each group of units randomized | Colony forming units | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Composite Compliance With Expected Infection Prevention Practices Upon Entry to Contact Precaution-patient Rooms | Donning Non-Sterile Gloves Without Hand Hygiene | 1297 | Participants | ||
| Number of Participants With Composite Compliance With Expected Infection Prevention Practices Upon Entry to Contact Precaution-patient Rooms | Hand Hygiene Before Donning Non-Sterile Gloves | 954 | Participants | ||
| Proportion of Healthcare Worker Who Use Glove on Entry Into Contact Precaution Rooms | Donning Non-Sterile Gloves Without Hand Hygiene | 1297 | Participants | ||
| Proportion of Healthcare Worker Who Use Glove on Entry Into Contact Precaution Rooms | Hand Hygiene Before Donning Non-Sterile Gloves | 1530 | Participants | ||
| Proportion of Healthcare Workers Who Perform Hand Hygiene on Entry Into Non-contact Precaution Room | Donning Non-Sterile Gloves Without Hand Hygiene | 1111 | Participants | ||
| Proportion of Healthcare Workers Who Perform Hand Hygiene on Entry Into Non-contact Precaution Room | Hand Hygiene Before Donning Non-Sterile Gloves | 951 | Participants | ||
| Proportion of Healthcare Worker Who Perform Hand Hygiene on Exit From Any Room | Donning Non-Sterile Gloves Without Hand Hygiene | 1525 | Participants | ||
| Proportion of Healthcare Worker Who Perform Hand Hygiene on Exit From Any Room | Hand Hygiene Before Donning Non-Sterile Gloves | 1587 | Participants | ||
| Mean Total Bacterial Colony Count | Donning Non-Sterile Gloves Without Hand Hygiene | 16.3 | Full Range 0 to 300 | Colony forming units | |
| Mean Total Bacterial Colony Count | Hand Hygiene Before Donning Non-Sterile Gloves | 9.5 | Full Range 0 to 300 | Colony forming units |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | HH Before Donning Non-Sterile Gloves | 6,791 | 7 |
| Overall Study | STARTED | Donning Non-Sterile Gloves Without HH | 7,627 | 6 |
| Overall Study | COMPLETED | HH Before Donning Non-Sterile Gloves | 6,791 | 7 |
| Overall Study | COMPLETED | Donning Non-Sterile Gloves Without HH | 7,627 | 6 |
| Overall Study | NOT COMPLETED | HH Before Donning Non-Sterile Gloves | 0 | 0 |
| Overall Study | NOT COMPLETED | Donning Non-Sterile Gloves Without HH | 0 | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | HH Before Donning Non-Sterile Gloves | 0 | 6,700 |
| Total, all-cause mortality | Donning Non-Sterile Gloves Without HH | 0 | 6,158 |
| Total, other adverse events | HH Before Donning Non-Sterile Gloves | 0 | 6,700 |
| Total, other adverse events | Donning Non-Sterile Gloves Without HH | 0 | 6,158 |
| Total, serious adverse events | HH Before Donning Non-Sterile Gloves | 0 | 6,700 |
| Total, serious adverse events | Donning Non-Sterile Gloves Without HH | 0 | 6,158 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37883088 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Donning Non-Sterile Gloves Without Hand Hygiene vs Hand Hygiene Before Donning Non-Sterile Gloves: Proportion of Healthcare Worker Who Perform Hand Hygiene on Exit From Any Room | Trial comparisons |
Donning Non-Sterile Gloves Without Hand Hygiene vs Hand Hygiene Before Donning Non-Sterile Gloves: Number of Participants With Composite Compliance With Expected Infection Prevention Practices Upon Entry to Contact Precaution-patient Rooms | Trial comparisons |
| Donning Non-Sterile Gloves Without Hand Hygiene vs Hand Hygiene Before Donning Non-Sterile Gloves: Proportion of Healthcare Workers Who Perform Hand Hygiene on Entry Into Non-contact Precaution Room | Trial comparisons |
| HH Before Donning Non-Sterile Gloves vs Donning Non-Sterile Gloves Without HH: deaths from any cause | Trial comparisons |
| Donning Non-Sterile Gloves Without Hand Hygiene vs Hand Hygiene Before Donning Non-Sterile Gloves: Proportion of Healthcare Worker Who Use Glove on Entry Into Contact Precaution Rooms | Trial comparisons |
| HH Before Donning Non-Sterile Gloves vs Donning Non-Sterile Gloves Without HH: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03119389
GET https://conductscience.org/api/trials/v1/NCT03119389/registered