Early Versus Delayed Bathing of Orthopaedic Surgical Wounds
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital for Special Surgery, New York
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Time to bathing (delayed)
Other interventionDelayed bathing-- patients will be told to begin showering after wound exam and suture removal (10-20 day postoperative).
Time to bathing (early)
Other interventionEarly bathing--Patients will be told to remove dressings and begin showering with body soap on postoperative day 3.
Treatment groups
56 Participants
are divided into 2 treatment groupsGroup A: Delayed BathingActive comparator 1 intervention
Group B: Early BathingActive comparator 1 intervention
Trial outcomes
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."
Time frame
Weeks 2, 6 and 12 post surgerySecondary outcomes
1
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
Time frame
Weeks 12 post surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Hospital for Special Surgery, New York
Lead sponsor
New York Presbyterian Hospital
Collaborator
Source ClinicalTrials.gov