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AzTrials

Wound HealNCT06373900

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

A study testing wound closure in people with Wound Heal and Wound Dehiscence, run by Indus Hospital and Health Network at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Wound Heal, Wound Dehiscence, Wound Complication
What is being tested?
wound closure
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 sitePakistan
Study dates
13 Feb 2022to 30 Mar 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Indus Hospital and Health Network

    Karachi, Sindh, 74900

Other trials in Pakistan

About this study

Official title: Wound Closure After Total Knee Arthroplasty: Comparison of Polypropylene and Polyglactin 910 Suture. A Randomised Controlled Trial.

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.

Read the detailed description

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.

Being tested
wound closure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • wound closureProcedure or surgery

    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.

Study groups in NCT06373900
Study groupRoleWhat they receive
Group AActive comparatorwound closure with polypropylene
Receives: Procedure: wound closure
Group BActive comparatorwound closure with polyglactin 910 suture
Receives: Procedure: wound closure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 30 days after surgery

  2. 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.

    Measured: 30 days after surgery

  3. 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

    Measured: 30 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2024
  2. Study start13 Feb 2022
  3. Primary completion19 Feb 2022
  4. Study completion30 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06373900
Sponsor's protocol ID
IndusH
Status last verified
Apr 2024
First submitted
25 Mar 2024
Last updated
18 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35310806

  • 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.

    PubMed 31663286

  • 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.

    PubMed 25579802

  • 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.

    PubMed 17403800

  • 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.

    PubMed 22864619

  • 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.

    PubMed 29166680

  • 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.

    PubMed 21142740

  • 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.

    PubMed 30705543

  • 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.

    PubMed 16434531

  • 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.

    PubMed 30350827

  • 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.

    PubMed 34129758

  • 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.

    PubMed 22011354

  • 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.

    PubMed 27190132

  • 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.

    PubMed 7741347

  • 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.

    PubMed 25733009

Questions about this trial

What is this clinical trial studying?

A study testing wound closure in people with Wound Heal and Wound Dehiscence, run by Indus Hospital and Health Network at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Wound characteristics and complications (time frame: 30 days after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06373900, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.

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