Early Versus Delayed Bathing of Orthopaedic Surgical Wounds

Phase

N/A

Condition

Pressure Ulcer

Treatment

Time to bathing (early)

Time to bathing (delayed)

Clinical Study ID

NCT06014411

2023-1723

21-04023565

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

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 notrequiring external fixation, and acute fracture surgery)

Exclusion

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)

Study Design

Time to bathing (early)

January 29, 2024

March 31, 2026

Study 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.