Wound Closure Materials and Techniques in Hip and Knee Arthroplasty
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30+
SponsorBahattin Kemah
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Age < 30 years
Patients receiving immunosuppressive therapy
Patients with complicated diabetes mellitus
Chronic venous insufficiency
Trial design
Design model
Parallel
Treatments tested in this trial
Barbed Suture Wound Closure
Procedure/SurgeryWound closure using barbed suture material with continuous technique following total hip or knee arthroplasty.
Conventional Suture Wound Closure
Procedure/SurgeryWound closure using conventional suture material with interrupted or standard closure technique following total hip or knee arthroplasty.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Barbed Suture GroupExperimental treatment 1 intervention
Group B: Conventional Suture GroupActive comparator 1 intervention
Trial outcomes
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.
Time frame
Within 90 days after surgerySecondary outcomes
1
Operative Time
Duration of surgery measured in minutes from skin incision to wound closure.
Time frame
Intraoperative (Day of surgery)2
Intraoperative Blood Loss
Estimated blood loss measured in milliliters during surgery.
Time frame
Intraoperative (Day of surgery)3
Duration of Postoperative Wound Drainage
Number of days with visible wound drainage after surgery.
Time frame
Within 90 days after surgery4
Surgical Site Infection Rate
Incidence of superficial or deep surgical site infection diagnosed according to clinical criteria within 90 days postoperatively.
Time frame
Within 90 days after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Bahattin Kemah
Lead sponsor
Umraniye Education and Research Hospital
Sponsor institution
Source ClinicalTrials.gov