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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Barbed Suture Wound Closure | Procedure | Wound closure using barbed suture material with continuous technique following total hip or knee arthroplasty. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Operative Time | Duration of surgery measured in minutes from skin incision to wound closure. | Intraoperative (Day of surgery) |
| Intraoperative Blood Loss | Estimated blood loss measured in milliliters during surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bahattin Kemah, MD | Contact | +905337198121 | bahattinkemah.md@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Bahattin Kemah, MD | Umraniye Education and Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Umraniye Training and Research Hospital | Recruiting | Istanbul | Istanbul | 34764 | Turkey (Türkiye) |
Individual participant data will not be shared to protect patient confidentiality and comply with institutional policies.
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D015207 | Osteoarthritis, Hip |
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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Participants will be randomly assigned in a 1:1 ratio to one of two wound closure methods following total hip or knee arthroplasty.
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| Conventional Suture Wound Closure | Procedure | Wound closure using conventional suture material with interrupted or standard closure technique following total hip or knee arthroplasty. |
|
| Intraoperative (Day of surgery) |
| Duration of Postoperative Wound Drainage | Number of days with visible wound drainage after surgery. | Within 90 days after surgery |
| Surgical Site Infection Rate | Incidence of superficial or deep surgical site infection diagnosed according to clinical criteria within 90 days postoperatively. | Within 90 days after surgery |
| Wound Dehiscence | Incidence of partial or complete wound separation within 90 days postoperatively. | Within 90 days after surgery |
| Functional Outcome Score | 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 |
| D012216 |
| Rheumatic Diseases |
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |