Wound Closure After Total Knee Replacement

Wound of Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03788239
• Other study ID #: IRD_IRB_2017_06_006
• Status: Terminated
• Phase: N/A
• Start date: December 19, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2024
• Source: Indus Hospital and Health Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 211
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Wound of Knee
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
Pakistan	The Indus Hospital	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Indus Hospital and Health Network

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound healing	Wound healing will be assessed using Hollander Score	Surgery till 1 year post-op
Primary	Complications		Surgery till 1 year post-op