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

Wound Heal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06373900
• Other study ID #: IndusH
• Status: Completed
• Phase: N/A
• Start date: February 13, 2022
• Est. completion date: March 30, 2022

Study information

• Verified date: April 2024
• Source: Indus Hospital and Health Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. patient followed on 3rd, 7th, 15th and 30th post operative day for wound healing, wound dehiscence and scar formation.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 30, 2022
• Est. primary completion date: February 19, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Wound Complication
• Wound Dehiscence
• Wound Heal
• Wounds and Injuries

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Pakistan	Indus Hospital and Health Network	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Indus Hospital and Health Network

Country where clinical trial is conducted

Pakistan, 

References & Publications (15)

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 — View Citation

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):5 — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Ann Emerg Med 1995 Oct;26(4):532. — View Citation

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. — View Citation

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.88B2.16 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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/s11999-012-25 — View Citation

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: 10.1186/175 — View Citation

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. — View Citation

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; — View Citation

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: 10.1302/204 — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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