Early Versus Delayed Bathing of Orthopaedic Surgical Wounds (EVDB)

Early Versus Delayed Bathing of Orthopaedic Surgical Wounds: a Prospective Randomized Controlled Study

This is a single center randomized control trial assessing the effect of early versus delayed bathing on orthopaedic surgical wounds in patients undergoing surgical treatment of fractures. Patients will be recruited by screening all patients undergoing surgical treatment for fractures at our institution. Patients who provide written consent will be randomized to one of two treatment arms after confirming eligibility criteria. Group A will be advised to begin early normal bathing (non-submerged showering) with uncovered surgical wounds. Group B will be advised to follow traditional delayed bathing with covered wounds.

Those who do not wish to participate in the randomized trial will be invited to participate observationally (no randomization) and have the same prospective follow-up.

Study Overview

• Status: Recruiting
• Conditions: Surgical Wound; Post Operative Wound Infection
• Intervention / Treatment: Other: Time to bathing (delayed); Other: Time to bathing (early)

Detailed Description

The study is a single center, non-inferiority, parallel group, randomized control trial assessing the effect of early versus delayed bathing on orthopaedic surgical wounds in patients undergoing surgical treatment of fractures. Patients will be recruited by screening all patients undergoing surgical treatment for fractures at our institution. Patients who provide written consent will be randomized to one of two treatment arms after confirming eligibility criteria. Group A will be advised to begin early normal bathing (non-submerged showering) with uncovered surgical wounds. Group B will be advised to follow traditional delayed bathing with covered wounds.

Patients will have follow-up with data collection at two, six and 12 weeks post-operatively. The primary outcome measure will be patient satisfaction as measured by a Likert Scale. The Likert Scale as utilized will be a patient reported outcome measure consisting of one question allowing the subject to express their attitude towards a particular subject: "How satisfied are you with your surgical treatment" with possible answers consisting of: "very satisfied", "somewhat satisfied", "neutral", "somewhat unsatisfied", and "very unsatisfied". The secondary outcome measures will be development of an infection (subcategorized as either superficial or deep) and development of peri-incisional inflammation (eg. adhesive rash).

Primary Objective: The primary objective of the study is to compare patient satisfaction as measured using a Likert Scale associated with early and delayed surgical site bathing.

Secondary Objectives: The secondary objective is to compare the infection rate of orthopaedic surgical wounds between early and delayed bathing.

Those who do not wish to participate in the randomized trial will be invited to participate observationally (no randomization) and have the same prospective follow-up.

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: William M Ricci, MD; Phone Number: 212-606-1026; Email: ricciw@hss.edu
• Study Contact Backup: Name: Craig E Klinger, BA; Phone Number: 212-606-1641; Email: klingerc@hss.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • NewYork-Presbyterian/Weill Cornell Medical Center
      • Contact: William M Ricci, MD; Phone Number: 212-606-1026; Email: ricciw@hss.edu
      • Contact: Craig E Klinger, BA; Phone Number: 212-606-1641; Email: klingerc@hss.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients over 18 years of age
• Patient who are not pregnant
• Isolated acute fractures of the upper or lower extremities (humerus, radius, ulna, femur, tibia, or fibula)
• Diagnosis of a fracture meeting indication for operative intervention
• Any fracture not requiring a splint for post-operative management
• Non-complicated wounds (non-traumatic wounds, closed injuries, fractures not requiring external fixation, and acute fracture surgery)

Exclusion Criteria:

• Fractures associated with presumed infection
• Patients with multiple fractures
• Fractures in patients with underlying associated immune compromise
• Fractures in patients with underlying peripheral vascular disease
• Use of VAC
• Surgery performed through previous surgical wound
• Patient homeless
• Fractures in patients with underlying diabetes mellitus
• Complicated wounds (traumatic wounds, need for post-op wound care, open injuries, need for external fixation)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Delayed Bathing; Delayed bathing-- patients will be told to begin showering after wound exam and suture removal (10-20 day postoperative).	Other: Time to bathing (delayed); Delayed bathing-- patients will be told to begin showering after wound exam and suture removal (10-20 day postoperative).
Active Comparator: Early Bathing; Early bathing--Patients will be told to remove dressings and begin showering with body soap on postoperative day 3.	Other: Time to bathing (early); Early bathing--Patients will be told to remove dressings and begin showering with body soap on postoperative day 3.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction associated with early and delayed surgical site bathing	The primary endpoint of the study will be a statistically significant difference in patient satisfaction as measured using a Likert Scale between the two groups. Scale will be on scale 0-10. A score of 10 will be "Very Satisfied" and a score of 0 will be "Very Dissatisfied."	Weeks 2, 6 and 12 post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infection rate of orthopaedic surgical wounds between early and delayed bathing	The secondary endpoint in this study will be a statistically significant or clinically important difference in infection rate of orthopaedic surgical wounds between the early and delayed bathing groups	Weeks 12 post surgery

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York
• Collaborators: New York Presbyterian Hospital
• Investigators: Principal Investigator: William M Ricci, MD, Hospital for Special Surgery, New York

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: August 21, 2023
• First Submitted That Met QC Criteria: August 21, 2023
• First Posted (Actual): August 28, 2023

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Postoperative Complications; Pathologic Processes; Infections; Wound Infection; Pathological Conditions, Signs and Symptoms; Surgical Wound; Surgical Wound Infection
• Other Study ID Numbers: 2023-1723; 21-04023565 (Other Identifier: Weill Cornell Medicine IRB #)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No