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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06007599
Other study ID # MAUS2023-2092
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date August 16, 2023
Est. completion date October 30, 2024

Study information

Verified date August 2023
Source Rothman Institute Orthopaedics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Wound complications after total knee arthroplasty (TKA) can arise from many patient-specific factors, such as vascular or immune-related medical conditions, obesity, and smoking, among others. The development of early wound complications can lead to increased length of hospital stay and more serious complications, including deep infection and major subsequent surgery. However, there are modifiable variables that could affect the risk of getting wound complications, such as the closure technique. This study aims to analyze the difference in rates of wound complications using two different closure techniques in primary TKA.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 216
Est. completion date October 30, 2024
Est. primary completion date October 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients older than 18 years old that will undergo primary TKA with a midline approach Exclusion Criteria: - Previous knee arthroplasty surgeries or midline scars - TKA secondary to oncologic or traumatic etiologies - BMI = 40 - uncontrolled diabetes (measured by a Hgb A1c above 8) - reported allergy to skin adhesive - immunodeficiencies - bleeding disorders - anticoagulation other than ASA

Study Design


Intervention

Procedure:
Skin closure using skin adhesive
Wound closure using subcuticular running 3-0 monocryl sutures with skin adhesive
Skin closure without skin adhesive
Wound closure using subcuticular running 3-0 monocryl sutures without skin adhesive

Locations

Country Name City State
United States Rothman Orthopaedic Institute Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary wound complications Assessed using Photographic documentation of the wound 90 days
Primary Patient satisfaction Assessed using the POSAS (patient and observer scar assessment scale) questionnaire 90 days
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