Wound Closure After Total Knee Replacement
Primary Purpose
Wound of Knee
Status
Unknown status
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Staples versus sutures
Sponsored by
About this trial
This is an interventional treatment trial for Wound of Knee
Eligibility 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)
Sites / Locations
- The Indus HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm 1
Arm 2
Arm Description
Right knee wound closure by staples and Left Knee wound closure by sutures
Right knee wound closure by sutures and Left Knee wound closure by staples
Outcomes
Primary Outcome Measures
Wound healing
Wound healing will be assessed using Hollander Score
Complications
Secondary Outcome Measures
Full Information
NCT ID
NCT03788239
First Posted
December 24, 2018
Last Updated
December 24, 2018
Sponsor
Indus Hospital and Health Network
1. Study Identification
Unique Protocol Identification Number
NCT03788239
Brief Title
Wound Closure After Total Knee Replacement
Official Title
Wound Closure After Total Knee Replacement: Comparison Between Staples and Sutures.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 19, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indus Hospital and Health Network
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound of Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
211 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Right knee wound closure by staples and Left Knee wound closure by sutures
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
Right knee wound closure by sutures and Left Knee wound closure by staples
Intervention Type
Other
Intervention Name(s)
Staples versus sutures
Intervention Description
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 Measure Information:
Title
Wound healing
Description
Wound healing will be assessed using Hollander Score
Time Frame
Surgery till 1 year post-op
Title
Complications
Time Frame
Surgery till 1 year post-op
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Facility Information:
Facility Name
The Indus Hospital
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75100
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Waseem Memon
Phone
03313334112
Email
dr.waseemmemon@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Wound Closure After Total Knee Replacement
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