Early Versus Delayed Bathing of Orthopaedic Surgical Wounds

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-29

Study Completion Date

2026-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Surgical Wound Post Operative Wound Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Delayed Bathing

Delayed bathing-- patients will be told to begin showering after wound exam and suture removal (10-20 day postoperative).

Group Type ACTIVE_COMPARATOR

Time to bathing (delayed)

Intervention Type OTHER

Delayed bathing-- patients will be told to begin showering after wound exam and suture removal (10-20 day postoperative).

Early Bathing

Early bathing--Patients will be told to remove dressings and begin showering with body soap on postoperative day 3.

Group Type ACTIVE_COMPARATOR

Time to bathing (early)

Intervention Type OTHER

Early bathing--Patients will be told to remove dressings and begin showering with body soap on postoperative day 3.

Interventions

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Time to bathing (delayed)

Delayed bathing-- patients will be told to begin showering after wound exam and suture removal (10-20 day postoperative).

Intervention Type OTHER

Time to bathing (early)

Early bathing--Patients will be told to remove dressings and begin showering with body soap on postoperative day 3.

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No