Wound Healing in Primary TKA

Rothman Institute Orthopaedics

Status: Invitation-only

Conditions: Wound Complication; Total Knee Replacement

Treatments: Procedure: Skin closure using skin adhesive; Procedure: Skin closure without skin adhesive

Study type: Interventional

Funder types: Other

Identifiers

NCT06007599

MAUS2023-2092

Details and patient eligibility

About

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.

Enrollment: 216 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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216 participants in 2 patient groups

Group A: suture with skin adhesive

Active Comparator group

Description:

After surgery the closure technique utilized by the surgeons will be subcuticular running 3-0 monocryl sutures without skin adhesive

Treatment:

Procedure: Skin closure using skin adhesive

Group B: suture without skin adhesive

Active Comparator group

Description:

After surgery the closure technique utilized by the surgeons will be subcuticular running 3-0 monocryl sutures with skin adhesive.

Treatment:

Procedure: Skin closure without skin adhesive