Wound Closure After Total Knee Replacement

Study Overview
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Brief Summary
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To compare the wound healing after total knee replacement wound closure with staples versus subcuticular prolene suture.

Detailed Description
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.Informed consent will be taken from all the patients who meet the inclusion and exclusion criteria and then will be randomized into one of the two study arms (Arm 1: will undergo wound closure with staples and Arm 2 wound closure with subcuticular prolene suture). before the start of surgery. The primary investigator will open the sealed envelopes provided by the Indus Hospital Research Center's Clinical Research Unit (CRU) that provides the study arm allocation. The envelopes will follow the SNOSE protocol i.e. they will be sequentially numbered, opaque sealed envelopes. Before opening the envelope, the primary investigator will write the patient's medical record number, date and will sign the envelope. The envelope will contain carbon paper which will transfer the data allocation paper inside.

Official Title
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Wound Closure After Total Knee Replacement: Comparison Between Staples and Sutures.

Conditions
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Wound of Knee

Intervention / Treatment
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* Other: Staples versus sutures


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing primary total knee replacements for osteoarthritis or post-traumatic arthritis (diagnosed on X-rays and history) Bilateral knee surgeries Patients giving informed consent Exclusion Criteria: Patients having previous skin, neuromuscular or connective tissue disorder (confirmed by history) Patients taking steroids (confirmed by history) Body mass index > 30 (increases chances of wound dehiscence) Lack of consent Pregnant females (confirmed by history)

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Right knee wound closure by staples and Left Knee wound closure by sutures | Other: Staples versus sutures<br>* Prolene suture: non-absorbable, sterile surgical suture composed of an isotactic crystalline steroisomer of polypropylene, a synthetic linear polyolefin. After completion of the procedure, deep tissues will closed with subcuticular prolene suture. Compared to the absorbable sutures, prolene is known to cause less infection since it is a monofilament material. Staples: specialized staples used in surgery in place of sutures to close skin wounds. After completion of the procedure, deep tissues were closed with absorbable braided suture, then the skin will be closed by staples.<br>|
| Experimental: Arm 2<br>Right knee wound closure by sutures and Left Knee wound closure by staples | Other: Staples versus sutures<br>* Prolene suture: non-absorbable, sterile surgical suture composed of an isotactic crystalline steroisomer of polypropylene, a synthetic linear polyolefin. After completion of the procedure, deep tissues will closed with subcuticular prolene suture. Compared to the absorbable sutures, prolene is known to cause less infection since it is a monofilament material. Staples: specialized staples used in surgery in place of sutures to close skin wounds. After completion of the procedure, deep tissues were closed with absorbable braided suture, then the skin will be closed by staples.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing | Wound healing will be assessed using Hollander Score | Surgery till 1 year post-op | 
| Complications |  | Surgery till 1 year post-op |