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Wound Closure After Total Knee Replacement

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ClinicalTrials.gov Identifier: NCT03788239
Recruitment Status : Recruiting
First Posted : December 27, 2018
Last Update Posted : December 27, 2018
Sponsor:
Information provided by (Responsible Party):
Indus Hospital

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

Condition or disease Intervention/treatment Phase
Wound of Knee Other: Staples versus sutures Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 211 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Wound Closure After Total Knee Replacement: Comparison Between Staples and Sutures.
Actual Study Start Date : December 19, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


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.





Primary Outcome Measures :
  1. Wound healing [ Time Frame: Surgery till 1 year post-op ]
    Wound healing will be assessed using Hollander Score

  2. Complications [ Time Frame: Surgery till 1 year post-op ]


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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03788239


Locations
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Pakistan
The Indus Hospital Recruiting
Karachi, Sindh, Pakistan, 75100
Contact: Waseem Memon    03313334112    dr.waseemmemon@gmail.com   
Sponsors and Collaborators
Indus Hospital

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Responsible Party: Indus Hospital
ClinicalTrials.gov Identifier: NCT03788239     History of Changes
Other Study ID Numbers: IRD_IRB_2017_06_006
First Posted: December 27, 2018    Key Record Dates
Last Update Posted: December 27, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Wounds and Injuries