Early Versus Delayed Bathing of Orthopaedic Surgical Wounds

NCT06014411 | Recruiting

• 2 other identifiers: 2023-172321-04023565
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Surgical Wound; Post Operative Wound Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Infection rate of orthopaedic surgical wounds between early and delayed bathing

  Weeks 12 post surgery

Study Arms (2)

Delayed Bathing

ACTIVE COMPARATOR

Delayed bathing-- patients will be told to begin showering after wound exam and suture removal (10-20 day postoperative).

Other: Time to bathing (delayed)

Early Bathing

ACTIVE COMPARATOR

Early bathing--Patients will be told to remove dressings and begin showering with body soap on postoperative day 3.

Other: Time to bathing (early)

Interventions

Time to bathing (early) OTHER

Early bathing--Patients will be told to remove dressings and begin showering with body soap on postoperative day 3.

Early Bathing

Time to bathing (delayed) OTHER

Delayed bathing-- patients will be told to begin showering after wound exam and suture removal (10-20 day postoperative).

Delayed Bathing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead
• New York Presbyterian Hospital: collaborator

Study Sites (1)

NewYork-Presbyterian/Weill Cornell Medical Center

New York, New York, 10065, United States

RECRUITING

MeSH Terms

Conditions

Surgical Wound; Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wounds and Injuries; Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• William M Ricci, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Central Study Contacts

William M Ricci, MD

CONTACT

212-606-1026; ricciw@hss.edu

Craig E Klinger, BA

CONTACT

212-606-1641; klingerc@hss.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Orthopaedic Trauma Service

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: August 28, 2023
• Study Start: January 29, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

US (1)