Wound Closure Materials and Techniques in Hip and Knee Arthroplasty

NCT07439575 | Recruiting

• 1 other identifier: WOMBAT-2025
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective randomized clinical study aims to evaluate the effects of different suture materials and wound closure techniques on wound healing, functional outcomes, and postoperative complications in patients undergoing total hip and knee arthroplasty. A total of at least 90 adult patients undergoing primary or aseptic revision lower extremity arthroplasty will be randomized into two groups according to the wound closure material and technique used. All surgeries will be performed by the same surgical team following standardized operative protocols. Primary outcomes include wound-related complications such as prolonged wound drainage, wound dehiscence, surgical site infection, and local inflammatory findings within 90 days postoperatively. Secondary outcomes include operative time, bleeding amount, cosmetic outcomes, and functional scores. The results of this study are expected to help determine the most effective and safe wound closure method in lower extremity arthroplasty.

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip

Keywords

Total Knee Arthroplasty; Total Hip Arthroplasty; Wound Closure; Barbed Suture; Surgical Site Infection; Wound Healing; Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Incidence of wound-related complications within 90 days postoperatively

  Wound-related complications include prolonged wound drainage, wound dehiscence, surgical site infection, and local inflammatory findings occurring within 90 days following total hip or knee arthroplasty.

  Within 90 days after surgery

Secondary Outcomes (6)

• Operative Time

  Intraoperative (Day of surgery)

• Intraoperative Blood Loss

  Intraoperative (Day of surgery)

• Duration of Postoperative Wound Drainage

  Within 90 days after surgery

• Surgical Site Infection Rate

  Within 90 days after surgery

• Wound Dehiscence

  Within 90 days after surgery

Study Arms (2)

Barbed Suture Group

EXPERIMENTAL

Patients undergoing total hip or knee arthroplasty in whom wound closure is performed using barbed suture material and continuous closure technique.

Procedure: Barbed Suture Wound Closure

Conventional Suture Group

ACTIVE COMPARATOR

Patients undergoing total hip or knee arthroplasty in whom wound closure is performed using conventional suture material and standard closure technique.

Procedure: Conventional Suture Wound Closure

Interventions

Barbed Suture Wound Closure PROCEDURE

Wound closure using barbed suture material with continuous technique following total hip or knee arthroplasty.

Barbed Suture Group

Conventional Suture Wound Closure PROCEDURE

Wound closure using conventional suture material with interrupted or standard closure technique following total hip or knee arthroplasty.

Conventional Suture Group

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 30 years
• Patients undergoing primary total hip arthroplasty or total knee arthroplasty
• Patients undergoing aseptic revision total hip or knee arthroplasty
• Surgery performed by the same surgical team
• Ability to provide informed consent

You may not qualify if:

• Age \< 30 years
• Patients receiving immunosuppressive therapy
• Patients with complicated diabetes mellitus
• Chronic venous insufficiency
• Peripheral arterial disease
• Arthroplasty performed due to malignancy
• Active or previous surgical site infection

Sponsors & Collaborators

• Bahattin Kemah: lead

Study Sites (1)

Umraniye Training and Research Hospital

Istanbul, Istanbul, 34764, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip; Surgical Wound Infection

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bahattin Kemah, MD

  Umraniye Education and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bahattin Kemah, MD

CONTACT

+905337198121; bahattinkemah.md@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Orthopedic Surgeon, Department of Orthopedics

Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two wound closure methods following total hip or knee arthroplasty.

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: February 27, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)