Post Operative Wound Infection, Surgical Wound
Conditions
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.
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.
Interventions
OTHERTime to bathing (delayed)
Delayed bathing-- patients will be told to begin showering after wound exam and suture removal (10-20 day postoperative).
OTHERTime to bathing (early)
Early bathing--Patients will be told to remove dressings and begin showering with body soap on postoperative day 3.
Sponsors
Hospital for Special Surgery, New York
New York Presbyterian Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction associated with early and delayed surgical site bathing | 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
| Measure | Time frame | Description |
|---|---|---|
| Infection rate of orthopaedic surgical wounds between early and delayed bathing | 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 |
Countries
United States
Contacts
CONTACTWilliam M Ricci, MD
CONTACTCraig E Klinger, BA
PRINCIPAL_INVESTIGATORWilliam M Ricci, MD
Hospital for Special Surgery, New York
Outcome results
None listed