Clinical trial NCT06014411: Early Versus Delayed Bathing of Orthopaedic Surgical Wounds
Official title: Early Versus Delayed Bathing of Orthopaedic Surgical Wounds: a Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Surgical Wound
Post Operative Wound Infection
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
Collaborators: name: New York Presbyterian Hospital
First posted: 2023-08-28
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Patient satisfaction associated with early and delayed surgical site bathing
timeFrame: Weeks 2, 6 and 12 post surgery
Secondary outcomes:
measure: Infection rate of orthopaedic surgical wounds between early and delayed bathing
timeFrame: Weeks 12 post surgery
Other outcomes:
Locations:
city: New York
country: United States
facility: NewYork-Presbyterian/Weill Cornell Medical Center
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: William M Ricci, MD
role: PRINCIPAL_INVESTIGATOR
References: