Total Knee Replacement Clinical Trial
Official title:
Comparison of Surgical Site Infection After Skin Closure by Prolene or Staples in Bilateral Knee Arthroplasty Patients: A Parallel Design Randomized Controlled Trial
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.
Study Enrollment Procedures:
Enrollment will be a continuous process with screening and enrolling eligible patients
admitted through the clinic electively for primary TKR. Informed consent will be taken from
the patient as per routine protocol before the arthroplasty procedures in the hospital.
Research objectives, methodology, risks, and benefits will be explained in detail. Consent
for the participation in the study will only be taken by the primary investigator at his
clinic or the surgical resident on call preoperatively along with the consent for the
surgical procedure.
Pre-Randomization Evaluations Screening:
The screening will involve the routine history taking and physical examination by the doctor
and nursing staff in the clinic. Screening won't involve performing procedures that are not
part of routine management.
On-study/on-intervention evaluations:
After screening and assessing the eligibility, patients will be randomly allocated by a 1:1
ratio to the two intervention groups i.e. prolene or staple using a computer-generated
randomization sequence by the clinical trials unit (CTU), which they will provide to the PI,
after patients' admission in the hospital. Patients will be followed from the time they reach
the ward after surgery until their hospital discharge, which is usually around 7 days.
Data Collection:
The data collection will be done by the surgical site infection (SSI) nurses from the
infection control department of AKUH. These nurses are well-trained to assess the surgical
site infections in all the surgery patients admitted to the hospital. Training of data
collectors will be done by the PI to ensure the reliability and validity of the study. The
data collectors will be strictly instructed to respect the autonomy of participants. Data
collection will be done by the data collectors under the supervision of the PI and CTU.
Questionnaires will be checked for consistency and logical data entries. Data entry will be
done, and counter checked by the PI at regular intervals.
Data Storage:
Data collected will be coded and kept confidential without the identifiable information of
patients. The confidentiality of the study participants will be maintained throughout the
study period. Data collected will be kept confidential without identifiable information of
patients who are identified by a number assigned. The hard copy forms will be retained in a
secured location with the PI after data entry into computer software and will be kept as per
hospital protocol. The password-protected drives will be used to store data with only the PI
having access to it. The data will be available for AKUH ethical review committee on request
and might be published in a journal without disclosing any identifiable information of
patients. Filled questionnaires will be stored for 5 years after the study is completed as
per the policy of the institute.
Sample Size:
The sample size was calculated via open epi software version 3.01. The level of significance
was kept at 5% with a power of 80%. The percentage of exposed (staple sutures) with outcome
(surgical site infection) was 66%. The percentage of non-exposed (Prolene sutures) with
outcome (surgical site infection) was 33%. The estimated risk ratio taken from a study was 2.
After adding the non-response rate of 10% the final sample size came out to be 82 patients
with 41 patients in each arm.
Plan of Analysis:
Statistical analysis will be done by using STATA software version 15. The normality
assumption for the quantitative variables would be assessed using the shapiro wilk test. Mean
± SD will be computed for all the normally distributed quantitative variables. The median and
interquartile range would be reported for the non-normally distributed quantitative
variables. The categorical variables would be expressed in frequencies and percentages. The
Cox Proportional Hazard regression will be used for the univariate and multivariable
analysis. Univariate analysis will be conducted, and crude risk ratios and their 95%
confidence intervals will be obtained. All significant independent variables at the
univariate stage will be regressed in a multivariable cox proportional hazard regression
using the stepwise method in the multivariable model and the adjusted risk ratios will be
obtained.
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