Back to resultsWound Healing in Primary TKA
Primary Purpose
Total Knee Replacement, Wound Complication
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Skin closure using skin adhesive
Skin closure without skin adhesive
Sponsored by
About this trial
This is an interventional treatment trial for Total Knee Replacement
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 BMI ≥ 40 uncontrolled diabetes (measured by a Hgb A1c above 8) reported allergy to skin adhesive immunodeficiencies bleeding disorders anticoagulation other than ASA
Sites / Locations
- Rothman Orthopaedic Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A: suture with skin adhesive
Group B: suture without skin adhesive
Arm Description
After surgery the closure technique utilized by the surgeons will be subcuticular running 3-0 monocryl sutures without skin adhesive
After surgery the closure technique utilized by the surgeons will be subcuticular running 3-0 monocryl sutures with skin adhesive.
Outcomes
Primary Outcome Measures
wound complications
Assessed using Photographic documentation of the wound
Patient satisfaction
Assessed using the POSAS (patient and observer scar assessment scale) questionnaire
Secondary Outcome Measures
Full Information
NCT ID
NCT06007599
First Posted
August 17, 2023
Last Updated
August 17, 2023
Sponsor
Rothman Institute Orthopaedics
1. Study Identification
Unique Protocol Identification Number
NCT06007599
Brief Title
Wound Healing in Primary TKA
Official Title
Surgical Wound Healing With and Without the Use of Skin Adhesive in Primary TKA
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 16, 2023 (Actual)
Primary Completion Date
October 30, 2024 (Anticipated)
Study Completion Date
October 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rothman Institute Orthopaedics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Knee Replacement, Wound Complication
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
216 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A: suture with skin adhesive
Arm Type
Active Comparator
Arm Description
After surgery the closure technique utilized by the surgeons will be subcuticular running 3-0 monocryl sutures without skin adhesive
Arm Title
Group B: suture without skin adhesive
Arm Type
Active Comparator
Arm Description
After surgery the closure technique utilized by the surgeons will be subcuticular running 3-0 monocryl sutures with skin adhesive.
Intervention Type
Procedure
Intervention Name(s)
Skin closure using skin adhesive
Intervention Description
Wound closure using subcuticular running 3-0 monocryl sutures with skin adhesive
Intervention Type
Procedure
Intervention Name(s)
Skin closure without skin adhesive
Intervention Description
Wound closure using subcuticular running 3-0 monocryl sutures without skin adhesive
Primary Outcome Measure Information:
Title
wound complications
Description
Assessed using Photographic documentation of the wound
Time Frame
90 days
Title
Patient satisfaction
Description
Assessed using the POSAS (patient and observer scar assessment scale) questionnaire
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
BMI ≥ 40
uncontrolled diabetes (measured by a Hgb A1c above 8)
reported allergy to skin adhesive
immunodeficiencies
bleeding disorders
anticoagulation other than ASA
Facility Information:
Facility Name
Rothman Orthopaedic Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Wound Healing in Primary TKA
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