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Clinical Trials/NCT06007599
NCT06007599
Enrolling By Invitation
Not Applicable

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

Rothman Institute Orthopaedics1 site in 1 country216 target enrollmentAugust 16, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Total Knee Replacement
Sponsor
Rothman Institute Orthopaedics
Enrollment
216
Locations
1
Primary Endpoint
Patient satisfaction
Status
Enrolling By Invitation
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 16, 2023
End Date
October 30, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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
  • uncontrolled diabetes (measured by a Hgb A1c above 8)
  • reported allergy to skin adhesive
  • immunodeficiencies
  • bleeding disorders
  • anticoagulation other than ASA

Outcomes

Primary Outcomes

Patient satisfaction

Time Frame: 90 days

Assessed using the POSAS (patient and observer scar assessment scale) questionnaire

wound complications

Time Frame: 90 days

Assessed using Photographic documentation of the wound

Study Sites (1)

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