Osteoarthritis, KneeNCT07439575
Wound Closure Materials and Techniques in Hip and Knee Arthroplasty
A study testing Barbed Suture Wound Closure and Conventional Suture Wound Closure in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by Bahattin Kemah at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Osteoarthritis, Hip
- What is being tested?
- Barbed Suture Wound Closure and Conventional Suture Wound Closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Umraniye Training and Research Hospital
Istanbul, Istanbul, 34764
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip
- Being tested
- Barbed Suture Wound Closure, Conventional Suture Wound Closure
- Keywords
- Total Knee Arthroplasty, Total Hip Arthroplasty, Wound Closure, Barbed Suture, Surgical Site Infection, Wound Healing, Arthroplasty
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Barbed Suture Wound ClosureProcedure or surgery
Wound closure using barbed suture material with continuous technique following total hip or knee arthroplasty.
Conventional Suture Wound ClosureProcedure or surgery
Wound closure using conventional suture material with interrupted or standard closure technique following total hip or knee arthroplasty.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Conventional Suture Wound Closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 90 days after surgery
Secondary outcomes (6)
Operative Time
Duration of surgery measured in minutes from skin incision to wound closure.
Measured: Intraoperative (Day of surgery)
Intraoperative Blood Loss
Estimated blood loss measured in milliliters during surgery.
Measured: Intraoperative (Day of surgery)
Duration of Postoperative Wound Drainage
Number of days with visible wound drainage after surgery.
Measured: 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.
Measured: Within 90 days after surgery
Wound Dehiscence
Incidence of partial or complete wound separation within 90 days postoperatively.
Measured: 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.
Measured: Preoperatively and at 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Nov 2025
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bahattin Kemah
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Bahattin Kemah, Umraniye Education and Research Hospital
- Investigators
- Bahattin Kemah, MD, Principal investigator, Umraniye Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07439575
- Sponsor's protocol ID
- WOMBAT-2025
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect patient confidentiality and comply with institutional policies.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Different Suture Materials and Closure Techniques in Lower Extremity Arthroplasty: Effects on Wound Healing, Functional Outcomes, and Complications
- ClinicalTrials.gov ID
- NCT07439575
- Acronym / sponsor ID
- WOMBAT-2025
- Conditions
- Osteoarthritis, Knee, Osteoarthritis, Hip
- Keywords
- Total Knee Arthroplasty, Total Hip Arthroplasty, Wound Closure, Barbed Suture, Surgical Site Infection, Wound Healing, Arthroplasty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Bahattin KemahOther government
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Barbed Suture Group | Experimental | Procedure: Barbed Suture Wound ClosurePatients 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 | Procedure: Conventional Suture Wound ClosurePatients undergoing total hip or knee arthroplasty in whom wound closure is performed using conventional suture material and standard closure technique. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Age < 30 years
- Patients receiving immunosuppressive therapy
- Patients with complicated diabetes mellitus
- Chronic venous insufficiency
- Peripheral arterial disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Barbed Suture Wound ClosureWound closure using barbed suture material with continuous technique following total hip or knee arthroplasty. | Procedure or surgery | Barbed Suture Group |
| Conventional Suture Wound ClosureWound closure using conventional suture material with interrupted or standard closure technique following total hip or knee arthroplasty. | Procedure or surgery | Conventional Suture Group |
Primary outcome
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.
6 secondary outcomes
Operative Time
Time frame: Intraoperative (Day of surgery)
Intraoperative Blood Loss
Time frame: Intraoperative (Day of surgery)
Duration of Postoperative Wound Drainage
Time frame: Within 90 days after surgery
Surgical Site Infection Rate
Time frame: Within 90 days after surgery
Wound Dehiscence
Time frame: Within 90 days after surgery
Functional Outcome Score
Time frame: Preoperatively and at 3 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect patient confidentiality and comply with institutional policies.
Related trials for Osteoarthritis, Knee
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bahattin Kemah, MD principal investigator
Umraniye Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Barbed Suture Wound Closure and Conventional Suture Wound Closure in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by Bahattin Kemah at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bahattin Kemah, MD (+905337198121, bahattinkemah.md@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of wound-related complications within 90 days postoperatively (time frame: Within 90 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.