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

April 15, 2024 updated by: Indus Hospital and Health Network

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74900
        • Indus Hospital and Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
wound closure with polypropylene
Procedure: wound closure
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.
Active Comparator: Group B
wound closure with polyglactin 910 suture
Procedure: wound closure
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days after surgery
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.
30 days after surgery
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
30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indus Hospital and Health Network

Investigators

  • Principal Investigator: Nek Mohammad, The Indus Hospital and Health Network

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2022

Primary Completion (Actual)

February 19, 2022

Study Completion (Actual)

March 30, 2022

Study Registration Dates

First Submitted

March 25, 2024

First Submitted That Met QC Criteria

April 15, 2024

First Posted (Actual)

April 18, 2024

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IndusH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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