Osteoarthritis, Hip, Osteoarthritis, Knee
Conditions
Keywords
Total Knee Arthroplasty, Total Hip Arthroplasty, Wound Closure, Barbed Suture, Surgical Site Infection, Wound Healing, Arthroplasty
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.
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.
Interventions
PROCEDUREBarbed Suture Wound Closure
Wound closure using barbed suture material with continuous technique following total hip or knee arthroplasty.
PROCEDUREConventional Suture Wound Closure
Wound closure using conventional suture material with interrupted or standard closure technique following total hip or knee arthroplasty.
Sponsors
Bahattin Kemah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomly assigned in a 1:1 ratio to one of two wound closure methods following total hip or knee arthroplasty.
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of wound-related complications within 90 days postoperatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative Time | Intraoperative (Day of surgery) | Duration of surgery measured in minutes from skin incision to wound closure. |
| Intraoperative Blood Loss | Intraoperative (Day of surgery) | Estimated blood loss measured in milliliters during surgery. |
| Duration of Postoperative Wound Drainage | Within 90 days after surgery | Number of days with visible wound drainage after surgery. |
| Surgical Site Infection Rate | Within 90 days after surgery | Incidence of superficial or deep surgical site infection diagnosed according to clinical criteria within 90 days postoperatively. |
| Wound Dehiscence | Within 90 days after surgery | Incidence of partial or complete wound separation within 90 days postoperatively. |
| Functional Outcome Score | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTBahattin Kemah, MD
PRINCIPAL_INVESTIGATORBahattin Kemah, MD
Umraniye Education and Research Hospital
Outcome results
None listed