NewYork-Presbyterian/Weill Cornell Medical Center
New York, 10065, United States
Location status: Recruiting
Location contact
Craig E Klinger, BA
CONTACT
William M Ricci, MD
CONTACT
NCT Number: NCT06014411
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
New York, 10065, United States
Location status: Recruiting
Craig E Klinger, BA
CONTACT
William M Ricci, MD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Delayed bathing-- patients will be told to begin showering after wound exam and suture removal (10-20 day postoperative).
Early bathing--Patients will be told to remove dressings and begin showering with body soap on postoperative day 3.
Time frame: Weeks 2, 6 and 12 post surgery
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."
Time frame: Weeks 12 post surgery
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
Contact information is provided by the study sponsor or research team.
Craig E Klinger, BA
CONTACT
William M Ricci, MD
CONTACT
Hospital for Special Surgery, New York
Other
Early Versus Delayed Bathing of Orthopaedic Surgical Wounds: a Prospective Randomized Controlled Study
Acronym: EVDB
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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