Wound Healing in Primary TKA

Total Knee Replacement Clinical Trial

Official title:

Surgical Wound Healing With and Without the Use of Skin Adhesive in Primary TKA

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06007599
• Other study ID #: MAUS2023-2092
• Status: Enrolling by invitation
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Total Knee Replacement
• Wound Complication
• Wounds and Injuries

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