Wound Closure After Total Knee Replacement

NCT ID: NCT03788239

Last Updated: 2024-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

211 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-19

Study Completion Date

2021-12-31

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.

Conditions

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Wound of Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Right knee wound closure by staples and Left Knee wound closure by sutures

Group Type EXPERIMENTAL

Staples versus sutures

Intervention Type OTHER

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.

Arm 2

Right knee wound closure by sutures and Left Knee wound closure by staples

Group Type EXPERIMENTAL

Staples versus sutures

Intervention Type OTHER

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.

Interventions

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Staples versus sutures

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.

Intervention Type OTHER

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)
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Indus Hospital and Health Network

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Indus Hospital

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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IRD_IRB_2017_06_006

Identifier Type: -

Identifier Source: org_study_id

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