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NCT Number: NCT06014411

Early Versus Delayed Bathing of Orthopaedic Surgical Wounds

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Time to bathing (delayed)

Other

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

Time to bathing (early)

Other

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

Primary outcomes

  1. Patient satisfaction associated with early and delayed surgical site bathing

    Time frame: Weeks 2, 6 and 12 post surgery

    The primary endpoint of the study will be a statistically significant difference in patient satisfaction as measured using a Likert Scale between the two groups. Scale will be on scale 0-10. A score of 10 will be "Very Satisfied" and a score of 0 will be "Very Dissatisfied."

Secondary outcomes

  1. Infection rate of orthopaedic surgical wounds between early and delayed bathing

    Time frame: Weeks 12 post surgery

    The secondary endpoint in this study will be a statistically significant or clinically important difference in infection rate of orthopaedic surgical wounds between the early and delayed bathing groups

Study contacts

Contact information is provided by the study sponsor or research team.

Craig E Klinger, BA

CONTACT

[email protected]

212-606-1641

William M Ricci, MD

CONTACT

[email protected]

212-606-1026

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Collaborators

  • New York Presbyterian Hospital

Registry information

Official study title

Early Versus Delayed Bathing of Orthopaedic Surgical Wounds: a Prospective Randomized Controlled Study

Acronym: EVDB

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 28, 2023
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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