Ignite Creation Date:
2024-05-06 @ 7:26 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06014411
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2023-08-21
Brief Title:
Early Versus Delayed Bathing of Orthopaedic Surgical Wounds
Sponsor:
Hospital for Special Surgery New York
Organization:
Hospital for Special Surgery New York
Study Overview
Official Title:
Early Versus Delayed Bathing of Orthopaedic Surgical Wounds a Prospective Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EVDB
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 21-04023565 | OTHER | Weill Cornell Medicine IRB | None |