RecruitingNot Applicable

Early Versus Delayed Bathing of Orthopaedic Surgical Wounds

United States56 participantsStarted 2024-01-29

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Patient satisfaction associated with early and delayed surgical site bathing

Timeframe: Weeks 2, 6 and 12 post surgery

Trial details

NCT IDNCT06014411

SponsorHospital for Special Surgery, New York

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

William M Ricci, MD

212-606-1026 ricciw@hss.edu

View on ClinicalTrials.gov More Surgical Wound trials