Wound Closure After Total Knee Replacement

Not Applicable

Terminated

• Conditions: Wound of Knee
• Interventions: Other: Staples versus sutures

• Registration Number: NCT03788239
• Lead Sponsor: Indus Hospital and Health Network

Brief Summary

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

Detailed Description

.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.

Study Timeline

• Study Start: 2018-12-19
• Study First Submitted: 2018-12-24
• Study First Submitted QC: 2018-12-24
• Study First Posted: 2018-12-27
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 211

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Staples versus sutures	Right knee wound closure by sutures and Left Knee wound closure by staples
Arm 1	Staples versus sutures	Right knee wound closure by staples and Left Knee wound closure by sutures

Primary Outcome Measures

Name	Time	Method
Wound healing	Surgery till 1 year post-op	Wound healing will be assessed using Hollander Score
Complications	Surgery till 1 year post-op

Trial Locations

Locations (1)

The Indus Hospital; 🇵🇰 Karachi, Sindh, Pakistan