Comparison of Surgical Site Infection After Skin Closure by Prolene or Staples in Bilateral Knee Arthroplasty Patients
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interventional
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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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2020
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 27, 2020
CompletedFirst Posted
Study publicly available on registry
July 30, 2020
CompletedStudy Start
First participant enrolled
November 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedAugust 3, 2020
July 1, 2020
11 months
July 27, 2020
July 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Surgical Site Infection
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.
6 weeks for superficial infections and 1 year for deep infections
Secondary Outcomes (2)
Post Operative complications
Within 2 weeks of surgery
Pain Score
post-operative follow up at 14th post-op day
Study Arms (2)
Interventional Arm 1
EXPERIMENTALAfter total knee replacement, the skin closure of the patients in this group will be done using polypropylene (PROLENE) sutures.
Interventional Arm 2
ACTIVE COMPARATORAfter total knee replacement, the skin closure of the patients in this group will be done using staple sutures.
Interventions
After total knee replacement, the skin closure of the patients in this group will be done using polypropylene (PROLENE) sutures.
After total knee replacement, the skin closure of the patients in this group will be done using staple sutures.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Indus Hospital and Health Networklead
- Aga Khan Universitycollaborator
Related Publications (7)
Liu S, Wang Y, Kotian RN, Li H, Mi Y, Zhang Y, He X. Comparison of Nonabsorbable and Absorbable Suture in Total Knee Arthroplasty. Med Sci Monit. 2018 Oct 23;24:7563-7569. doi: 10.12659/MSM.910785.
PMID: 30350827BACKGROUNDBarrow J, Divecha H, Board T. Skin closure in arthroplasty surgery: Current practice. Int Wound J. 2018 Dec;15(6):966-970. doi: 10.1111/iwj.12956. Epub 2018 Jul 6.
PMID: 29978557BACKGROUNDSmith TO, Sexton D, Mann C, Donell S. Sutures versus staples for skin closure in orthopaedic surgery: meta-analysis. BMJ. 2010 Mar 16;340:c1199. doi: 10.1136/bmj.c1199.
PMID: 20234041RESULTGatt D, Quick CR, Owen-Smith MS. Staples for wound closure: a controlled trial. Ann R Coll Surg Engl. 1985 Sep;67(5):318-20.
PMID: 3901864RESULTClayer M, Southwood RT. Comparative study of skin closure in hip surgery. Aust N Z J Surg. 1991 May;61(5):363-5. doi: 10.1111/j.1445-2197.1991.tb00235.x.
PMID: 2025190RESULTKhan RJ, Fick D, Yao F, Tang K, Hurworth M, Nivbrant B, Wood D. A comparison of three methods of wound closure following arthroplasty: a prospective, randomised, controlled trial. J Bone Joint Surg Br. 2006 Feb;88(2):238-42. doi: 10.1302/0301-620X.88B2.16923.
PMID: 16434531RESULTHasan O, Jiwani A, Mazhar L, Begum D, Lakdawala R, Noordin S. Comparison of Surgical Site Infection After Skin Closure by Prolene or Staples in Bilateral Simultaneous Knee Arthroplasty Patients: A Parallel Design Randomized Controlled Trial Protocol. Int J Surg Protoc. 2021 Aug 6;25(1):154-159. doi: 10.29337/ijsp.153. eCollection 2021.
PMID: 34430763DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ahsun Jiwani, MSc. Epibio
The Indus Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Junior Biostatistician
Study Record Dates
First Submitted
July 27, 2020
First Posted
July 30, 2020
Study Start
November 1, 2020
Primary Completion
October 1, 2021
Study Completion
December 1, 2021
Last Updated
August 3, 2020
Record last verified: 2020-07