Wound Healing in Primary TKA

• Sponsor: Rothman Institute Orthopaedics (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT06007599
• Collaborator: (none)
• Enrollment: 216
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 14.5
• Patients Per Site Per Month: 14.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Total Knee Replacement; Wound Complication	Procedure: Skin closure using skin adhesive; Procedure: Skin closure without skin adhesive	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 216 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Surgical Wound Healing With and Without the Use of Skin Adhesive in Primary TKA
• Actual Study Start Date: Aug 16, 2023
• Anticipated Primary Completion Date: Oct 30, 2024
• Anticipated Study Completion Date: Oct 30, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. wound complications [90 days]

   Assessed using Photographic documentation of the wound

2. Patient satisfaction [90 days]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rothman Orthopaedic Institute	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

• Rothman Institute Orthopaedics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rothman Institute Orthopaedics
• ClinicalTrials.gov Identifier: NCT06007599
• Other Study ID Numbers: MAUS2023-2092
• First Posted: Aug 23, 2023
• Last Update Posted: Aug 23, 2023
• Last Verified: Aug 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Wounds and Injuries

Study Results

No Results Posted as of Aug 23, 2023