Total Knee ReplacementNCT06007599
Wound Healing in Primary TKA
A study testing Skin closure using skin adhesive and Skin closure without skin adhesive in people with Total Knee Replacement and Wound Complication, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
Wound complications after total knee arthroplasty (TKA) can arise from many patient-specific factors, such as vascular or immune-related medical conditions, obesity, and smoking, among others. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Total Knee Replacement, Wound Complication
- What is being tested?
- Skin closure using skin adhesive and Skin closure without skin adhesive
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2023to 30 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients older than 18 years old that will undergo primary TKA with a midline approach
Who cannot join
- Previous knee arthroplasty surgeries or midline scars
- TKA secondary to oncologic or traumatic etiologies
- BMI ≥ 40
- uncontrolled diabetes (measured by a Hgb A1c above 8)
- reported allergy to skin adhesive
- immunodeficiencies
- bleeding disorders
- anticoagulation other than ASA
Trial locations and contacts
1 site in 1 country.
United States1 site
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: Surgical Wound Healing With and Without the Use of Skin Adhesive in Primary TKA
Wound complications after total knee arthroplasty (TKA) can arise from many patient-specific factors, such as vascular or immune-related medical conditions, obesity, and smoking, among others. The development of early wound complications can lead to increased length of hospital stay and more serious complications, including deep infection and major subsequent surgery. However, there are modifiable variables that could affect the risk of getting wound complications, such as the closure technique. This study aims to analyze the difference in rates of wound complications using two different closure techniques in primary TKA.
- Conditions
- Total Knee Replacement, Wound Complication
- Being tested
- Skin closure using skin adhesive, Skin closure without skin adhesive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin closure using skin adhesiveProcedure or surgery
Wound closure using subcuticular running 3-0 monocryl sutures with skin adhesive
Skin closure without skin adhesiveProcedure or surgery
Wound closure using subcuticular running 3-0 monocryl sutures without skin adhesive
| Study group | Role | What they receive |
|---|---|---|
| Group A: suture with skin adhesive | Active comparator | After surgery the closure technique utilized by the surgeons will be subcuticular running 3-0 monocryl sutures without skin adhesive Receives: Procedure: Skin closure using skin adhesive |
| Group B: suture without skin adhesive | Active comparator | After surgery the closure technique utilized by the surgeons will be subcuticular running 3-0 monocryl sutures with skin adhesive. Receives: Procedure: Skin closure without skin adhesive |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound complications
Assessed using Photographic documentation of the wound
Measured: 90 days
Patient satisfaction
Assessed using the POSAS (patient and observer scar assessment scale) questionnaire
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start16 Aug 2023
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ReplacementStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06007599
- Sponsor's protocol ID
- MAUS2023-2092
- Status last verified
- Aug 2023
- First submitted
- 17 Aug 2023
- Last updated
- 23 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Wound Healing With and Without the Use of Skin Adhesive in Primary TKA
- ClinicalTrials.gov ID
- NCT06007599
- Acronym / sponsor ID
- MAUS2023-2092
- Conditions
- Total Knee Replacement, Wound Complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 16 Aug 2023 (actual)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 23 Aug 2023 (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.
Wound complications after total knee arthroplasty (TKA) can arise from many patient-specific factors, such as vascular or immune-related medical conditions, obesity, and smoking, among others. The development of early wound complications can lead to increased length of hospital stay and more serious complications, including deep infection and major subsequent surgery. However, there are modifiable variables that could affect the risk of getting wound complications, such as the closure technique. This study aims to analyze the difference in rates of wound complications using two different closure techniques in primary TKA.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: suture with skin adhesive | Active comparator | Procedure: Skin closure using skin adhesiveAfter surgery the closure technique utilized by the surgeons will be subcuticular running 3-0 monocryl sutures without skin adhesive |
| Group B: suture without skin adhesive | Active comparator | Procedure: Skin closure without skin adhesiveAfter surgery the closure technique utilized by the surgeons will be subcuticular running 3-0 monocryl sutures with skin adhesive. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients older than 18 years old that will undergo primary TKA with a midline approach
Key exclusion criteria (8 listed)
- Previous knee arthroplasty surgeries or midline scars
- TKA secondary to oncologic or traumatic etiologies
- BMI ≥ 40
- uncontrolled diabetes (measured by a Hgb A1c above 8)
- reported allergy to skin adhesive
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 |
|---|---|---|
| Skin closure using skin adhesiveWound closure using subcuticular running 3-0 monocryl sutures with skin adhesive | Procedure or surgery | Group A: suture with skin adhesive |
| Skin closure without skin adhesiveWound closure using subcuticular running 3-0 monocryl sutures without skin adhesive | Procedure or surgery | Group B: suture without skin adhesive |
Primary outcome
wound complications
Time frame: 90 days
Assessed using Photographic documentation of the wound
Patient satisfaction
Time frame: 90 days
Assessed using the POSAS (patient and observer scar assessment scale) questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
Related trials for Total Knee Replacement
Recruiting
Knee Replacement Rehabilitation Care Pathways
Knee Replacement, Total
RecruitingPhase 3
Suzetrigine in TKA
Total Knee Arthroplasty (TKA), Total Knee Arthroplasty \(TKA\)
Recruiting
Binaural Beats for Postoperative Pain and Anxiety Reduction
TKA, THA
Recruiting
Comparison of the Effects of Apixaban on Thrombin Generation in Patients With de Novo Multiple Myeloma
Multiple Myeloma, Total Knee Replacement
Not yet recruiting
A Study on the Physiological Outcomes of the Enhanced Recovery After Surgery Model in Older Adults Undergoing Total Knee Arthroplasty
Total Knee Arthroplasty (Replacement)
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin closure using skin adhesive and Skin closure without skin adhesive in people with Total Knee Replacement and Wound Complication, run by Rothman Institute Orthopaedics at 1 site in United States.
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 1 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 23 Aug 2023. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
wound complications (time frame: 90 days). The study lists 2 primary outcomes in all. 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 23 Aug 2023; AzTrials last refreshed its copy on 31 Oct 2026.