NCT06373900

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 13, 2022

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2022

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2024

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 18, 2024

Completed
Last Updated

April 18, 2024

Status Verified

April 1, 2024

Enrollment Period

6 days

First QC Date

March 25, 2024

Last Update Submit

April 15, 2024

Conditions

Wound HealWound DehiscenceWound Complication

Outcome Measures

Primary Outcomes (3)

  • Wound characteristics and complications

    Post operative patient followed on 3rd, 7th, 15th and 30th day for the assessment of any erythema, wound dehiscence, discharge, blister around the wound, warmth and tenderness

    30 days after surgery

  • Wound Infection Grade

    wound infection grade assessed on post operative day 3rd, 7th, 15th and 30th as simple stitch abscess, surrounding cellulitis, any systematic symptoms or suture removed.

    30 days after surgery

  • Hollander Cosmetic Wound Evaluation Score

    Hollander score assessed on 3rd, 7th, 15th and 30th post operative day as step off border, contour, scar width, scar width, edge inversion and overall cosmesis

    30 days after surgery

Study Arms (2)

Group A

ACTIVE COMPARATOR

wound closure with polypropylene

Procedure: wound closure

Group B

ACTIVE COMPARATOR

wound closure with polyglactin 910 suture

Procedure: wound closure

Interventions

wound closurePROCEDURE

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 AGroup B

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 50 to 80 years
  • Both gender
  • Inform consent
  • End stage osteoarthritis

You may not qualify if:

  • Age less the 50 and more then 80
  • BMI more then 40
  • Rheumatoid Arthritis
  • lack of consent
  • Pregnant female

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indus Hospital and Health Network

Karachi, Sindh, 74900, Pakistan

Location

Related Publications (15)

  • 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.

    PMID: 35310806BACKGROUND

  • 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.

    PMID: 31663286RESULT

  • 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.

    PMID: 25579802RESULT

  • 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.

    PMID: 17403800RESULT

  • 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.

    PMID: 22864619RESULT

  • 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.

    PMID: 29166680RESULT

  • 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.

    PMID: 21142740RESULT

  • 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.

    PMID: 30705543RESULT

  • 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.

    PMID: 16434531RESULT

  • 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: 30350827RESULT

  • 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.

    PMID: 34129758RESULT

  • 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.

    PMID: 22011354RESULT

  • 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.

    PMID: 27190132RESULT

  • 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.

    PMID: 7741347RESULT

  • 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.

    PMID: 25733009RESULT

Study Officials

  • Nek Mohammad

    The Indus Hospital and Health Network

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
SNOS protocol
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2024

First Posted

April 18, 2024

Study Start

February 13, 2022

Primary Completion

February 19, 2022

Study Completion

March 30, 2022

Last Updated

April 18, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)