Wound Closure After Total Knee Replacement

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

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

Study Overview

• Status: Terminated
• Conditions: Wound of Knee
• Intervention / Treatment: Other: Staples versus sutures

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 Type: Interventional
• Enrollment (Actual): 211
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75100
      • The Indus Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; Right knee wound closure by staples and Left Knee wound closure by sutures	Other: 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.
Experimental: Arm 2; Right knee wound closure by sutures and Left Knee wound closure by staples	Other: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Indus Hospital and Health Network

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2018
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: December 24, 2018
• First Submitted That Met QC Criteria: December 24, 2018
• First Posted (Actual): December 27, 2018

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: IRD_IRB_2017_06_006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No