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Clinical Trials/NCT06373900
NCT06373900
Completed
Not Applicable

Wound Closure After Total Knee Arthroplasty: Comparison of Polypropylene and Polyglactin 910 Suture. A Randomised Controlled Trial.

Indus Hospital and Health Network1 site in 1 country40 target enrollmentFebruary 13, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Wound Heal
Sponsor
Indus Hospital and Health Network
Enrollment
40
Locations
1
Primary Endpoint
Wound Infection Grade
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Comparison of wound complication and scar formation in patient undergone bilateral total knee replacement comparison between polypropylene and polyglactin 910 suture. patient randomised according to SNOS protocol into group A and B for their right and left knee closure with each suture. patient followed on 3rd, 7th, 15th and 30th post operative day for wound healing, wound dehiscence and scar formation.

Detailed Description

All patients aged 50-80 years, belonging to either sex, diagnosed with end-stage osteoarthritis or post-traumatic arthritis, and scheduled for bilateral primary total knee arthroplasty at the Department of Orthopedics, Indus Hospital and Health Network, Karachi were enrolled in the study. Exclusion criteria included patients having existing skin, neuromuscular, or connective tissue disorders, rheumatoid arthritis, immunosuppression, morbid obesity, and pregnancy. All patients provided voluntary informed written consent before enrolment in the study. In all patients undergoing primary TKA, one knee was closed using polypropylene, whereas the other was closed with Polyglactin 910 sutures. All surgeries were performed by the same surgical team using a standard medial parapatellar approach. The number of sutures and wound closure techniques were standardized across both groups.

Registry
clinicaltrials.gov
Start Date
February 13, 2022
End Date
March 30, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Indus Hospital and Health Network
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age 50 to 80 years
  • Both gender
  • Inform consent
  • End stage osteoarthritis

Exclusion Criteria

  • Age less the 50 and more then 80
  • BMI more then 40
  • Rheumatoid Arthritis
  • lack of consent
  • Pregnant female

Outcomes

Primary Outcomes

Wound Infection Grade

Time Frame: 30 days after surgery

wound infection grade assessed on post operative day 3rd, 7th, 15th and 30th as simple stitch abscess, surrounding cellulitis, any systematic symptoms or suture removed.

Wound characteristics and complications

Time Frame: 30 days after surgery

Post operative patient followed on 3rd, 7th, 15th and 30th day for the assessment of any erythema, wound dehiscence, discharge, blister around the wound, warmth and tenderness

Hollander Cosmetic Wound Evaluation Score

Time Frame: 30 days after surgery

Hollander score assessed on 3rd, 7th, 15th and 30th post operative day as step off border, contour, scar width, scar width, edge inversion and overall cosmesis

Study Sites (1)

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