NCT03788239

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
211

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 19, 2018

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 24, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 27, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

April 16, 2024

Status Verified

April 1, 2024

Enrollment Period

3 years

First QC Date

December 24, 2018

Last Update Submit

April 15, 2024

Conditions

Wound of Knee

Outcome Measures

Primary Outcomes (2)

  • Wound healing

    Wound healing will be assessed using Hollander Score

    Surgery till 1 year post-op

  • Complications

    Surgery till 1 year post-op

Study Arms (2)

Arm 1

EXPERIMENTAL

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

Other: Staples versus sutures

Arm 2

EXPERIMENTAL

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

Other: Staples versus sutures

Interventions

Staples versus suturesOTHER

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 1Arm 2

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Indus Hospital

Karachi, Sindh, 75100, Pakistan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 24, 2018

First Posted

December 27, 2018

Study Start

December 19, 2018

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

April 16, 2024

Record last verified: 2024-04

Locations

PA(1)