Early Versus Delayed Bathing of Orthopaedic Surgical Wounds

Surgical Wound Clinical Trial

— EVDB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06014411
• Other study ID #: 2023-1723
• Secondary ID: 21-04023565
• Status: Recruiting
• Phase: N/A
• Start date: January 29, 2024
• Est. completion date: February 2025

Study information

• Verified date: March 2024
• Source: Hospital for Special Surgery, New York
• Contact: William M Ricci, MD
• Phone: 212-606-1026
• Email: ricciw[@]hss.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: February 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Post Operative Wound Infection
• Surgical Wound
• Surgical Wound Infection
• Wound Infection
• Wounds and Injuries

Intervention

Other:
• Time to bathing (delayed)
Delayed bathing-- patients will be told to begin showering after wound exam and suture removal (10-20 day postoperative).
• Time to bathing (early)
Early bathing--Patients will be told to remove dressings and begin showering with body soap on postoperative day 3.

Locations

Country	Name	City	State
United States	NewYork-Presbyterian/Weill Cornell Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York	New York Presbyterian Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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