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Completed

NCT Number: NCT06373900

Wound Closure After Total Knee Arthroplasty: Comparison of Polypropylene and Polyglactin 910 Suture.

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.

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Key information

Conditions

Wound Heal Wound Complication Wound Dehiscence

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indus Hospital and Health Network

Karachi, Sindh, 74900, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

wound closure

Procedure

Group A wound will be closed with Polypropylene and Group B wound will be closed with Polyglactin 910 suture. both wound closure followed for healing, infection and scar formation till 30th post operative day.

Primary outcomes

  1. 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

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Indus Hospital and Health Network

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 18, 2024
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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