Wound Healing in Primary TKA
Surgical Wound Healing With and Without the Use of Skin Adhesive in Primary TKA
1 other identifier
interventional
216
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 16, 2023
CompletedFirst Submitted
Initial submission to the registry
August 17, 2023
CompletedFirst Posted
Study publicly available on registry
August 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2024
CompletedAugust 23, 2023
August 1, 2023
1.2 years
August 17, 2023
August 17, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
wound complications
Assessed using Photographic documentation of the wound
90 days
Patient satisfaction
Assessed using the POSAS (patient and observer scar assessment scale) questionnaire
90 days
Study Arms (2)
Group A: suture with skin adhesive
ACTIVE COMPARATORAfter 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
ACTIVE COMPARATORAfter surgery the closure technique utilized by the surgeons will be subcuticular running 3-0 monocryl sutures with skin adhesive.
Interventions
Wound closure using subcuticular running 3-0 monocryl sutures with skin adhesive
Wound closure using subcuticular running 3-0 monocryl sutures without skin adhesive
Eligibility Criteria
You may qualify if:
- Patients older than 18 years old that will undergo primary TKA with a midline approach
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2023
First Posted
August 23, 2023
Study Start
August 16, 2023
Primary Completion
October 30, 2024
Study Completion
October 30, 2024
Last Updated
August 23, 2023
Record last verified: 2023-08