Wound Healing in Primary TKA

Not Applicable

• Conditions: Total Knee Replacement; Wound Complication
• Interventions: Procedure: Skin closure using skin adhesive; Procedure: Skin closure without skin adhesive

• Registration Number: NCT06007599
• Lead Sponsor: Rothman Institute Orthopaedics

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-08
• Study Start: 2023-08-16
• Study First Submitted: 2023-08-17
• Study First Submitted QC: 2023-08-17
• Last Update Submitted: 2023-08-17
• Study First Posted: 2023-08-23
• Last Update Posted: 2023-08-23
• Primary Completion: 2024-10-30
• Study Completion: 2024-10-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 216

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group A: suture with skin adhesive	Skin closure using skin adhesive	After surgery the closure technique utilized by the surgeons will be subcuticular running 3-0 monocryl sutures without skin adhesive
Group B: suture without skin adhesive	Skin closure without skin adhesive	After surgery the closure technique utilized by the surgeons will be subcuticular running 3-0 monocryl sutures with skin adhesive.

Primary Outcome Measures

Name	Time	Method
Patient satisfaction	90 days	Assessed using the POSAS (patient and observer scar assessment scale) questionnaire
wound complications	90 days	Assessed using Photographic documentation of the wound

Trial Locations

Locations (1)

Rothman Orthopaedic Institute; 🇺🇸 Philadelphia, Pennsylvania, United States