Surgical WoundEVDBNCT06014411
Early Versus Delayed Bathing of Orthopaedic Surgical Wounds
A study testing Time to bathing (delayed) and Time to bathing (early) in people with Surgical Wound and Post Operative Wound Infection, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Wound, Post Operative Wound Infection
- What is being tested?
- Time to bathing (delayed) and Time to bathing (early)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NewYork-Presbyterian/Weill Cornell Medical Center
New York, New York, 10065
William M Ricci, MD, 212-606-1026, ricciw@hss.edu
Craig E Klinger, BA, 212-606-1641, klingerc@hss.edu
About this study
Official title: Early Versus Delayed Bathing of Orthopaedic Surgical Wounds: a Prospective Randomized Controlled Study
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.
Read the 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.
- Conditions
- Surgical Wound, Post Operative Wound Infection
- Being tested
- Time to bathing (delayed), Time to bathing (early)
- Medical subject headings
- Surgical Wound, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Delayed Bathing | Active comparator | Delayed bathing-- patients will be told to begin showering after wound exam and suture removal (10-20 day postoperative). Receives: Other: Time to bathing (delayed) |
| Early Bathing | Active comparator | Early bathing--Patients will be told to remove dressings and begin showering with body soap on postoperative day 3. Receives: Other: Time to bathing (early) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction associated with early and delayed surgical site bathing
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."
Measured: Weeks 2, 6 and 12 post surgery
Secondary outcomes (1)
Infection rate of orthopaedic surgical wounds between early and delayed bathing
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
Measured: Weeks 12 post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start29 Jan 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical WoundStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Collaborators
- New York Presbyterian Hospital
- Responsible party
- Principal investigator, William Ricci, Hospital for Special Surgery, New York
- Investigators
- William M Ricci, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06014411
- Sponsor's protocol ID
- 2023-1723
- Other IDs
- 21-04023565
- Acronym
- EVDB
- Status last verified
- Mar 2026
- First submitted
- 21 Aug 2023
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Delayed Bathing of Orthopaedic Surgical Wounds: a Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06014411
- Acronym / sponsor ID
- EVDB / 2023-1723
- Conditions
- Surgical Wound, Post Operative Wound Infection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Collaborators
- New York Presbyterian Hospital
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delayed Bathing | Active comparator | Other: Time to bathing (delayed)Delayed bathing-- patients will be told to begin showering after wound exam and suture removal (10-20 day postoperative). |
| Early Bathing | Active comparator | Other: Time to bathing (early)Early bathing--Patients will be told to remove dressings and begin showering with body soap on postoperative day 3. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time to bathing (delayed)Delayed bathing-- patients will be told to begin showering after wound exam and suture removal (10-20 day postoperative). | Other | Delayed Bathing |
| Time to bathing (early)Early bathing--Patients will be told to remove dressings and begin showering with body soap on postoperative day 3. | Other | Early Bathing |
Primary outcome
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."
1 secondary outcome
Infection rate of orthopaedic surgical wounds between early and delayed bathing
Time frame: Weeks 12 post surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
William M Ricci, MD principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time to bathing (delayed) and Time to bathing (early) in people with Surgical Wound and Post Operative Wound Infection, run by Hospital for Special Surgery, New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact William M Ricci, MD (212-606-1026, ricciw@hss.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction associated with early and delayed surgical site bathing (time frame: Weeks 2, 6 and 12 post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.