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

NCT ID: NCT06373900

Last Updated: 2024-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-13

Study Completion Date

2022-03-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Wound Heal Wound Dehiscence Wound Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants
SNOS protocol

Study Groups

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Group A

wound closure with polypropylene

Group Type ACTIVE_COMPARATOR

wound closure

Intervention Type PROCEDURE

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.

Group B

wound closure with polyglactin 910 suture

Group Type ACTIVE_COMPARATOR

wound closure

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Indus Hospital and Health Network

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nek Mohammad

Role: PRINCIPAL_INVESTIGATOR

The Indus Hospital and Health Network

Locations

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Indus Hospital and Health Network

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

References

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Khan MA, Memon MW, Chinoy A, Javed S, Barkat R, Jiwani A. Wound closure after total knee replacement: Comparison between staples and sutures. Pak J Med Sci. 2022 Jan;38(2):340-344. doi: 10.12669/pjms.38.ICON-2022.5782.

Reference Type BACKGROUND
PMID: 35310806 (View on PubMed)

Li JW, Ma YS, Xiao LK. Postoperative Pain Management in Total Knee Arthroplasty. Orthop Surg. 2019 Oct;11(5):755-761. doi: 10.1111/os.12535.

Reference Type RESULT
PMID: 31663286 (View on PubMed)

Culliford D, Maskell J, Judge A, Cooper C, Prieto-Alhambra D, Arden NK; COASt Study Group. Future projections of total hip and knee arthroplasty in the UK: results from the UK Clinical Practice Research Datalink. Osteoarthritis Cartilage. 2015 Apr;23(4):594-600. doi: 10.1016/j.joca.2014.12.022. Epub 2015 Jan 9.

Reference Type RESULT
PMID: 25579802 (View on PubMed)

Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.

Reference Type RESULT
PMID: 17403800 (View on PubMed)

Maradit Kremers H, Visscher SL, Moriarty JP, Reinalda MS, Kremers WK, Naessens JM, Lewallen DG. Determinants of direct medical costs in primary and revision total knee arthroplasty. Clin Orthop Relat Res. 2013 Jan;471(1):206-14. doi: 10.1007/s11999-012-2508-z.

Reference Type RESULT
PMID: 22864619 (View on PubMed)

Faour M, Sodhi N, Khlopas A, Piuzzi NS, Stearns KL, Krebs VE, Higuera CA, Mont MA. Knee Position during Surgical Wound Closure in Total Knee Arthroplasty: A Review. J Knee Surg. 2018 Jan;31(1):6-12. doi: 10.1055/s-0037-1608838. Epub 2017 Nov 22.

Reference Type RESULT
PMID: 29166680 (View on PubMed)

Tajirian AL, Goldberg DJ. A review of sutures and other skin closure materials. J Cosmet Laser Ther. 2010 Dec;12(6):296-302. doi: 10.3109/14764172.2010.538413.

Reference Type RESULT
PMID: 21142740 (View on PubMed)

Agarwala S, Vijayvargiya M. Concealed cosmetic closure in total knee replacement surgery - A prospective audit assessing appearance and patient satisfaction. J Clin Orthop Trauma. 2019 Jan-Feb;10(1):111-116. doi: 10.1016/j.jcot.2017.11.002. Epub 2017 Nov 13.

Reference Type RESULT
PMID: 30705543 (View on PubMed)

Khan 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.

Reference Type RESULT
PMID: 16434531 (View on PubMed)

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.

Reference Type RESULT
PMID: 30350827 (View on PubMed)

Elbardesy H, Gul R, Guerin S. Subcuticular sutures versus staples for skin closure after primary hip arthroplasty. Acta Orthop Belg. 2021 Mar;87(1):55-64.

Reference Type RESULT
PMID: 34129758 (View on PubMed)

Newman JT, Morgan SJ, Resende GV, Williams AE, Hammerberg EM, Dayton MR. Modality of wound closure after total knee replacement: are staples as safe as sutures? A retrospective study of 181 patients. Patient Saf Surg. 2011 Oct 19;5(1):26. doi: 10.1186/1754-9493-5-26.

Reference Type RESULT
PMID: 22011354 (View on PubMed)

Yuenyongviwat V, Iamthanaporn K, Hongnaparak T, Tangtrakulwanich B. A randomised controlled trial comparing skin closure in total knee arthroplasty in the same knee: nylon sutures versus skin staples. Bone Joint Res. 2016 May;5(5):185-90. doi: 10.1302/2046-3758.55.2000629.

Reference Type RESULT
PMID: 27190132 (View on PubMed)

Hollander JE, Singer AJ, Valentine S, Henry MC. Wound registry: development and validation. Ann Emerg Med. 1995 May;25(5):675-85. doi: 10.1016/s0196-0644(95)70183-4.

Reference Type RESULT
PMID: 7741347 (View on PubMed)

Wyles CC, Jacobson SR, Houdek MT, Larson DR, Taunton MJ, Sim FH, Sierra RJ, Trousdale RT. The Chitranjan Ranawat Award: Running Subcuticular Closure Enables the Most Robust Perfusion After TKA: A Randomized Clinical Trial. Clin Orthop Relat Res. 2016 Jan;474(1):47-56. doi: 10.1007/s11999-015-4209-x.

Reference Type RESULT
PMID: 25733009 (View on PubMed)

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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IndusH

Identifier Type: -

Identifier Source: org_study_id

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