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Wound Healing in Primary TKA

Surgical Wound Healing With and Without the Use of Skin Adhesive in Primary TKA

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06007599
Enrollment
216
Registered
2023-08-23
Start date
2023-08-16
Completion date
2024-10-30
Last updated
2023-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Knee Replacement, Wound Complication

Brief 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. 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.

Interventions

PROCEDURESkin closure using skin adhesive

Wound closure using subcuticular running 3-0 monocryl sutures with skin adhesive

PROCEDURESkin closure without skin adhesive

Wound closure using subcuticular running 3-0 monocryl sutures without skin adhesive

Sponsors

Rothman Institute Orthopaedics
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Patients older than 18 years old that will undergo primary TKA with a midline approach

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
wound complications90 daysAssessed using Photographic documentation of the wound
Patient satisfaction90 daysAssessed using the POSAS (patient and observer scar assessment scale) questionnaire

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026