Actively Recruiting
Early Versus Delayed Bathing of Orthopaedic Surgical Wounds: a Prospective Randomized Controlled Study
Led by Hospital for Special Surgery, New York · Updated on 2026-03-30
56
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
H
Hospital for Special Surgery, New York
Lead Sponsor
N
New York Presbyterian Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of early versus delayed bathing on orthopedic surgical wounds in patients undergoing surgery for fractures. This randomized controlled trial aims to compare patient satisfaction and infection rates between two bathing schedules for surgical wounds. The study is conducted at a single center and includes adults with isolated acute fractures requiring surgery, excluding complicated wounds and certain medical conditions. Participants are randomly assigned to one of two groups. Group A will start early normal bathing by removing dressings and showering with body soap on postoperative day 3, with wounds uncovered. Group B will follow traditional delayed bathing, beginning showering after wound examination and suture removal, approximately 10 to 20 days after surgery, with wounds covered. Patients who decline randomization may participate observationally with the same follow-up. Participants will be followed up at 2, 6, and 12 weeks after surgery. Researchers will collect data on patient satisfaction using a Likert Scale and monitor for infections, distinguishing between superficial and deep infections, as well as peri-incisional inflammation like adhesive rash. The total study duration for each participant includes these follow-up visits, assessing both safety and satisfaction outcomes.
CONDITIONS
Brief Title
Early Versus Delayed Bathing of Orthopaedic Surgical Wounds
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients over 18 years of age
- Patients who are not pregnant
- Isolated acute fractures of the upper or lower extremities (humerus, radius, ulna, femur, tibia, or fibula)
- Diagnosis of a fracture requiring surgical treatment
- 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)
You will not qualify if you...
- Fractures associated with presumed infection
- Patients with multiple fractures
- Fractures in patients with underlying immune compromise
- Fractures in patients with peripheral vascular disease
- Use of vacuum-assisted closure (VAC)
- Surgery performed through previous surgical wound
- Patients who are homeless
- Fractures in patients with diabetes mellitus
- Complicated wounds (traumatic wounds, open injuries, need for post-operative wound care, or external fixation)
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment and consent
Duration - Up to 20 days post surgery
Participants are randomized to begin early bathing on postoperative day 3 or delayed bathing after wound exam and suture removal between days 10 to 20 post surgery.
Participants follow bathing instructions at home; no specific visits required for bathing adherence
Duration - 12 weeks post surgery
Participants have follow-up visits to assess patient satisfaction, infection, and peri-incisional inflammation after surgery.
3 visits (at 2, 6, and 12 weeks post-operatively)
Trial Site Locations
Total: 1 location
1
NewYork-Presbyterian/Weill Cornell Medical Center
New York, New York, United States, 10065
Actively Recruiting
Research Team
W
William M Ricci, MD
C
Craig E Klinger, BA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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