drugset / Trial / NCT03401749

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

NCT03401749

Phase 4 Terminated 203 enrolled University of Alabama at Birmingham
RandomizedParallel-groupDouble-blindPrevention

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.

Timeline

Start
2018-11-01
Primary completion
2020-12-01
Completion
2020-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Chlorhexidine gluconate Other / unclassified 2 % Topical

Indications

No indication recorded.