search
Back to results

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
Indus Hospital and Health Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound of Knee

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
December 24, 2018
Last Updated
December 24, 2018
Sponsor
Indus Hospital and Health Network
search

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

We'll reach out to this number within 24 hrs