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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06014411
Other study ID # 2023-1723
Secondary ID 21-04023565
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


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
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