Comparison of Surgical Site Infection After Skin Closure by Prolene or Staples in Bilateral Knee Arthroplasty Patients

Summary

Knee arthroplasty also known as the total knee replacement is an orthopedic surgical procedure done to resurface the knee that has been severely damaged by arthritis. The optimal goal of skin closure after the procedure is to promote rapid healing and an acceptable cosmetic result while minimizing the risk of infection. Skin closure after knee arthroplasty is done by using either of the two widely used sutures i.e. polypropylene (Prolene) sutures or the skin staple sutures. The literature is very scarce on knee arthroplasty patients and the results of the studies conducted have been inconclusive of the studies conducted on the patients of knee arthroplasty. Moreover, there are no standard guidelines as to which type of suture should be used. The type of sutures is being selected on the orders and wishes of the surgeon at the time of skin closure. Prolene sutures are made up of a synthetic steroisomer known as polypropylene. It is a monofilament non-absorbable, sterile surgical suture. They are indicated for use in general soft tissue. It Provides permanent tensile strength retention in tissue, even in the presence of infection. These sutures are exceptionally smooth for an easy passage through the tissue. Prolene sutures are widely used in cardiovascular, orthopedics, ophthalmic, and neurological surgical procedures. Another type of sutures that are used to close the surgical wound are the staple sutures. They are used as an alternative to the traditional Prolene sutures. They are non-absorbable and usually used on surgical wounds that are big, complex or hard to close by using Prolene. These are specialized staples made up of titanium, stainless steel or plastic.

Interventions:

The study will have 2 intervention arms. The patients will be randomized to receive either Prolene sutures for wound closure or staple sutures for wound closure. After the application of the intervention, routine care would be given to the patients postoperatively.

Hypothesis:

The investigators hypothesize that there is no difference in the incidence of surgical site infection in bilateral TKR patients with wound closure by Prolene vs staple.

Study Design:

This study will be conducted as an open blinded, parallel design, equivalence randomized controlled trial. The patients would be randomized to receive either of the two interventions i.e. Prolene or Staple sutures.

Conditions

• Total Knee Replacement

Interventions

PROCEDURE

Polypropylene (PROLENE) sutures

After total knee replacement, the skin closure of the patients in this group will be done using polypropylene (PROLENE) sutures.

PROCEDURE

Staple Sutures

After total knee replacement, the skin closure of the patients in this group will be done using staple sutures.

Sponsors & Collaborators

• Aga Khan University

  collaborator OTHER

• Indus Hospital and Health Network

  lead OTHER

Principal Investigators

• Ahsun Jiwani, MSc. Epibio · The Indus Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-11-30

Primary Completion

2021-10-31

Completion

2021-12-31