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NCT03401749 · ClinicalTrials.gov registry record · Phase 4

Preadmission Skin Wipe Use for Surgical Site Infection Prophylaxis in Adult Orthopaedic Surgery Patients

A Phase 4 study, sponsored by University of Alabama at Birmingham.

Terminated
Registry status
Phase 4
Development phase
203
Enrollment target

NCT03401749: Clinical Trial Phase 4 study, sponsored by University of Alabama at Birmingham.

NCT03401749 is a Phase 4 study that was terminated before completion, run by University of Alabama at Birmingham. The registered enrollment target is 203 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03401749, a Phase 4 study, was terminated before completion, sponsored by University of Alabama at Birmingham.

TERMINATED
Registry status
Phase 4
Development phase
203 participants
Enrollment target

Study Summary

Intervention: This study will involve three different study arms with different interventions prior to surgery: (1) shower only, (2) shower plus Theraworx wipes, (3) shower plus chlorhexidine wipes Study Design: Single center RCT Sample Size: 500 patients, aged 18+ Objectives: Primary Objectives: 1. Monitor for safety and adverse effects. 2. Evaluate for differences in peri-operative skin cultures between treatment groups; 3. Compare surgical site infection rates between groups. Secondary Objectives: 1. Assess for patient compliance for each different treatment arms. 2. Measure patient satisfaction. 3. Measure nurse satisfaction. 4. Visual assessment of wound healing Expected Results: We expect no statistically significant difference in peri-operative cultures or surgical site infection rates between groups.

Primary Outcome

Clinical development of a surgical site infection in the postoperative period.

Interventions

  • DRUG Chlorhexidine Gluconate 2% Wipe
  • OTHER Theraworx Bath Wipes

Trial Details

FieldValue
Enrollment Target 203 participants
Start Date 2018-11-01
Est. Completion 2020-12-01
Phase Phase 4
University of Alabama at Birmingham

1,160 total trials

Why NCT03401749 stopped before completion

NCT03401749 is an interventional study that assigns participants to a tested intervention. The registered 203 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (61% lower).

The record links to 0 conditions, and to 2 interventions - of which Chlorhexidine Gluconate 2% Wipe is the first listed.

NCT03401749 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03401749 about?

NCT03401749 is a clinical study titled "Preadmission Skin Wipe Use for Surgical Site Infection Prophylaxis in Adult Orthopaedic Surgery Patients". Intervention: This study will involve three different study arms with different interventions prior to surgery: (1) shower only, (2) shower plus Theraworx wipes, (3) shower plus chlorhexidine wipes Study Design: Single center RCT Sample Size: 500 patients, aged 18+ Objectives: Primary Objectives:...

What is the current status of trial NCT03401749?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 203 participants. The study started on 2018-11-01. Estimated completion is 2020-12-01.

What interventions are being tested in trial NCT03401749?

The interventions under investigation include: Chlorhexidine Gluconate 2% Wipe (DRUG), Theraworx Bath Wipes (OTHER).

Who is sponsoring clinical trial NCT03401749?

This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03401749's enrollment target sits among peer trials

203 403rd of 2000 higher than 1,597 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03401749, the US trial registry maintained by the National Library of Medicine. NCT03401749 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.