Wound Healing in Primary TKA

August 17, 2023 updated by: Rothman Institute Orthopaedics

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

216

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Rothman Orthopaedic Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A: suture with skin adhesive
After surgery the closure technique utilized by the surgeons will be subcuticular running 3-0 monocryl sutures without skin adhesive
Procedure: Skin closure using skin adhesive
Wound closure using subcuticular running 3-0 monocryl sutures with skin adhesive
Active Comparator: Group B: suture without skin adhesive
After surgery the closure technique utilized by the surgeons will be subcuticular running 3-0 monocryl sutures with skin adhesive.
Procedure: Skin closure without skin adhesive
Wound closure using subcuticular running 3-0 monocryl sutures without skin adhesive

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
wound complications
Time Frame: 90 days
Assessed using Photographic documentation of the wound
90 days
Patient satisfaction
Time Frame: 90 days
Assessed using the POSAS (patient and observer scar assessment scale) questionnaire
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rothman Institute Orthopaedics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 16, 2023

Primary Completion (Estimated)

October 30, 2024

Study Completion (Estimated)

October 30, 2024

Study Registration Dates

First Submitted

August 17, 2023

First Submitted That Met QC Criteria

August 17, 2023

First Posted (Actual)

August 23, 2023

Study Record Updates

Last Update Posted (Actual)

August 23, 2023

Last Update Submitted That Met QC Criteria

August 17, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAUS2023-2092

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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