- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07439575
Wound Closure Materials and Techniques in Hip and Knee Arthroplasty
Evaluation of Different Suture Materials and Closure Techniques in Lower Extremity Arthroplasty: Effects on Wound Healing, Functional Outcomes, and Complications
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Total hip and knee arthroplasty are commonly performed surgical procedures in the management of end-stage degenerative joint diseases. Optimal wound closure is critical in reducing postoperative complications such as prolonged wound drainage, wound dehiscence, surgical site infection, and delayed wound healing. Various suture materials and closure techniques are routinely used in clinical practice; however, consensus regarding the most effective method remains limited.
This prospective randomized study is designed to compare different suture materials and wound closure techniques in patients undergoing primary or aseptic revision total hip and knee arthroplasty. Participants will be randomly assigned in a 1:1 ratio to one of two wound closure strategies differing in both suture material and closure technique following total hip or knee arthroplasty. The study aims to determine their effects on wound healing, functional outcomes, and postoperative complications.
A minimum of 90 adult patients will be enrolled. Eligible patients will be randomized into two groups according to the wound closure material and technique used. All surgical procedures will be performed by the same surgical team following standardized perioperative protocols in order to minimize confounding variables.
Preoperative demographic data will be recorded. Intraoperative variables including operative time and intraoperative blood loss will be documented. Postoperative assessments will include wound drainage duration, signs of local inflammation, wound dehiscence, surgical site infection, bleeding complications, and cosmetic evaluation. Functional outcomes will be assessed using validated hip and knee scoring systems where applicable.
Patients will be followed for 90 days postoperatively. All data will be recorded in a secure database and analyzed using appropriate statistical methods. Continuous variables will be assessed for normal distribution and analyzed using parametric or non-parametric tests as appropriate. Categorical variables will be analyzed using Chi-square or Fisher's exact test. Multivariate logistic regression analysis will be performed to identify independent predictors of wound-related complications. A p-value < 0.05 will be considered statistically significant.
The findings of this study are expected to contribute to the optimization of wound closure strategies in lower extremity arthroplasty and improve postoperative outcomes.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Bahattin Kemah, MD
- Phone Number: +905337198121
- Email: bahattinkemah.md@gmail.com
Study Locations
-
-
Istanbul
-
Istanbul, Istanbul, Turkey (Türkiye), 34764
- Recruiting
- Ümraniye Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Barbed Suture Group
Patients undergoing total hip or knee arthroplasty in whom wound closure is performed using barbed suture material and continuous closure technique.
|
Wound closure using barbed suture material with continuous technique following total hip or knee arthroplasty.
|
|
Active Comparator: Conventional Suture Group
Patients undergoing total hip or knee arthroplasty in whom wound closure is performed using conventional suture material and standard closure technique.
|
Wound closure using conventional suture material with interrupted or standard closure technique following total hip or knee arthroplasty.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of wound-related complications within 90 days postoperatively
Time Frame: Within 90 days after surgery
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Operative Time
Time Frame: Intraoperative (Day of surgery)
|
Duration of surgery measured in minutes from skin incision to wound closure.
|
Intraoperative (Day of surgery)
|
|
Intraoperative Blood Loss
Time Frame: Intraoperative (Day of surgery)
|
Estimated blood loss measured in milliliters during surgery.
|
Intraoperative (Day of surgery)
|
|
Duration of Postoperative Wound Drainage
Time Frame: Within 90 days after surgery
|
Number of days with visible wound drainage after surgery.
|
Within 90 days after surgery
|
|
Surgical Site Infection Rate
Time Frame: Within 90 days after surgery
|
Incidence of superficial or deep surgical site infection diagnosed according to clinical criteria within 90 days postoperatively.
|
Within 90 days after surgery
|
|
Wound Dehiscence
Time Frame: Within 90 days after surgery
|
Incidence of partial or complete wound separation within 90 days postoperatively.
|
Within 90 days after surgery
|
|
Functional Outcome Score
Time Frame: Preoperatively and at 3 months postoperatively
|
Functional outcomes will be assessed using the Harris Hip Score (HHS) (range 0-100, with 100 indicating best possible function; higher scores indicate better clinical outcomes) for patients undergoing total hip arthroplasty, and the Knee Society Score (KSS) (range 0-100, with 100 indicating best possible function; higher scores indicate better clinical outcomes) for patients undergoing total knee arthroplasty.
|
Preoperatively and at 3 months postoperatively
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bahattin Kemah, MD, Umraniye Education and Research Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WOMBAT-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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