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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04492852
Recruitment Status : Unknown
Verified July 2020 by Ahsun Jiwani, Indus Hospital and Health Network.
Recruitment status was:  Not yet recruiting
First Posted : July 30, 2020
Last Update Posted : August 3, 2020
Sponsor:
Collaborator:
Aga Khan University
Information provided by (Responsible Party):
Ahsun Jiwani, Indus Hospital and Health Network

Brief 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.


Condition or disease Intervention/treatment Phase
Total Knee Replacement Procedure: Polypropylene (PROLENE) sutures Procedure: Staple Sutures Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Estimated Study Start Date : November 2020
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: Interventional Arm 1
After total knee replacement, the skin closure of the patients in this group will be done using polypropylene (PROLENE) sutures.
Procedure: Polypropylene (PROLENE) sutures
After total knee replacement, the skin closure of the patients in this group will be done using polypropylene (PROLENE) sutures.

Active Comparator: Interventional Arm 2
After total knee replacement, the skin closure of the patients in this group will be done using staple sutures.
Procedure: Staple Sutures
After total knee replacement, the skin closure of the patients in this group will be done using staple sutures.




Primary Outcome Measures :
  1. Surgical Site Infection [ Time Frame: 6 weeks for superficial infections and 1 year for deep infections ]
    Primary outcome of the study is the incidence of surgical site infection (superficial or deep) within 6 weeks for superficial infections and 1 year for deep infections.


Secondary Outcome Measures :
  1. Post Operative complications [ Time Frame: Within 2 weeks of surgery ]
    The secondary outcomes of the study include the incidence of post-operative complication that includes; seroma, hematoma, pain, or bleeding

  2. Pain Score [ Time Frame: post-operative follow up at 14th post-op day ]
    assess and compare the pain scores at the time of suture removal using the Visual Analogue Scale (VAS) pain scale. score of '0' represents no pain whereas a score of '10' represents severe/unbearable pain.



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients of age 40-70 years
  • Undergoing bilateral knee arthroplasty at AKUH Karachi.
  • Both the genders would be included.
  • Patients having American Society of Anesthesiologists (ASA) level of I, II and III
  • Patients having functional class of I, II and III pre-operatively
  • Patients opting to undergo Bilateral knee arthroplasty under care of the selected surgeon (A) for the study.
  • Patients undergoing bilateral TKR electively

Exclusion Criteria:

  • Patients unwilling to consent.
  • Patients unable to comprehend due to the language barrier
  • Patients who have a Glasgow Coma Scale i.e. GCS<15 (cognitive impairment)
  • Patients undergoing a knee revision surgery
  • Patients having a previous incision/scar in the operative field will be excluded
  • Patients having documented allergy to Prolene or stainless steel
  • Patients having a documented underlying malignancy
  • Patients undergoing unilateral TKR or staged bilateral TKR
  • Patients undergoing emergency TKR.
  • Patients having undergoing surgery due to trauma or fracture

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04492852


Contacts
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Contact: Dr Shahryar Noordin +922134864350 ext 4350 shahryar.noordin@aku.edu
Contact: Dilshad Begum +922134862303 ext 2303 dilshad.begum@aku.edu

Sponsors and Collaborators
Indus Hospital and Health Network
Aga Khan University
Investigators
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Principal Investigator: Ahsun Jiwani, MSc. Epibio The Indus Hospital
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ahsun Jiwani, Junior Biostatistician, Indus Hospital and Health Network
ClinicalTrials.gov Identifier: NCT04492852    
Other Study ID Numbers: 456-784-7
First Posted: July 30, 2020    Key Record Dates
Last Update Posted: August 3, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ahsun Jiwani, Indus Hospital and Health Network:
Knee Replacement
Prolene
Staples
Surgical Site Infection
Skin Closure
Additional relevant MeSH terms:
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Infections
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes