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Delayed Bathing for Surgical Wound (EVDB Trial)

N/A

Recruiting

Led By William M Ricci, MD

Research Sponsored by Hospital for Special Surgery, New York

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 2, 6 and 12 post surgery

Awards & highlights

EVDB Trial Summary

This trial will study whether bathing early or waiting to bathe after orthopaedic surgery affects wound healing. Patients getting surgery for fractures will be randomly assigned to bathe early (without soaking the wound)

Who is the study for?

This trial is for adults over 18 with fresh fractures in arms or legs (like the humerus, radius, ulna, femur, tibia, or fibula) that need surgery but don't need a splint afterward. Pregnant individuals and those with complicated wounds aren't eligible.Check my eligibility

What is being tested?

The study compares two ways of caring for surgical wounds after orthopaedic surgery: Group A will start showering early without covering their wounds while Group B will wait longer before bathing and keep their wounds covered.See study design

What are the potential side effects?

Potential side effects may include differences in wound healing times or rates of infection between the groups who bathe early versus those who delay bathing.

EVDB Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a recent single fracture in my arm or leg.

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I have a broken bone that needs surgery.

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I had a fracture that didn't need a splint after surgery.

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My wounds are simple, not from a major injury, and didn't need complex surgery.

EVDB Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 2, 6 and 12 post surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 2, 6 and 12 post surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 2, 6 and 12 post surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Patient satisfaction associated with early and delayed surgical site bathing

Secondary outcome measures

Infection rate of orthopaedic surgical wounds between early and delayed bathing

EVDB Trial Design

2Treatment groups

Active Control

Group I: Delayed BathingActive Control1 Intervention

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

Group II: Early BathingActive Control1 Intervention

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hospital for Special Surgery, New YorkLead Sponsor

243 Previous Clinical Trials

59,274 Total Patients Enrolled

New York Presbyterian HospitalOTHER

74 Previous Clinical Trials

49,164 Total Patients Enrolled

William M Ricci, MDPrincipal InvestigatorHospital for Special Surgery, New York

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit for the number of participants enrolled in this clinical trial?

"The data available on clinicaltrials.gov indicates that this research endeavor is presently in pursuit of potential participants. The trial was initially listed on January 29, 2024, with the most recent update recorded on February 14, 2024. A total of 56 patients are sought after across a solitary study site."

Answered by AI

Are medical professionals currently seeking participants for this trial?

"From the details disclosed on clinicaltrials.gov, it is apparent that this medical research study is actively seeking participants. The trial was introduced on January 29th, 2024 and most recently revised on February 14th, 2024."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Early Versus Delayed Bathing of Orthopaedic Surgical Wounds

William Ricci 2024. "Early Versus Delayed Bathing of Orthopaedic Surgical Wounds". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06014411.