Comparison of two wound closure methods after knee joint replacement in diabetic patients

• Register: IRCT
• Last refreshed on: 22 January 2024
• Main ID: IRCT20230928059543N1
• Date of registration: 2024-01-12
• Prospective Registration: Yes
• Primary sponsor: Shiraz University of Medical Sciences
• Public title: Comparison of two wound closure methods after knee joint replacement in diabetic patients
• Scientific title: Comparison of Surgical wound dehiscence and Infection rate in two Methods of Skin stapler and Nylon suture in Wound closure of Diabetic patients undergoing Total knee arthroplasty (TKA)
• Date of first enrolment: 2024-03-01
• Target sample size: 120
• Recruitment status: Pending
• URL: http://en.irct.ir/trial/74754
• Study type: interventional
• Study design: Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The participants will be randomly assigned to two groups of closure with nylon suture and closure with staples using Random Allocation computer Software (RAS)version 4.9 (Internet address: https://random-allocation-software.software.informer.com/2.0/ ). Random allocation by the permutation block method is listed in 15 blocks of 8 with random allocation software, the list provided is attached to the proposal.
• Phase: N/A

Countries of recruitment

Iran (Islamic Republic of)

Contacts

• Name: Armin Fereidouni
• Affiliation: Shiraz University of Medical Sciences

• Name: Armin Fereidouni
• Affiliation: Shiraz University of Medical Sciences

Key inclusion & exclusion criteria

Inclusion criteria: Willingness to participate in the study
Definitive diagnosis of diabetes through the examination of the patient's tests by an internal medicine specialist and the use of diabetes medications
presence of fasting blood sugar between 70 and 130 mg/dL
Age range from 40 to 90 years
Exclusion criteria: History of cancer and chemotherapy, uncontrolled internal and vascular diseases
Reduction of blood albumin
Taking systemic corticosteroid drugs before surgery
Having a history of knee surgery or the presence of scars and wounds in the knee area
Getting infectious and viral diseases (colds and COVID-19) before and after surgery
Increased blood urea
Suffering from immunosuppressive diseases

Age minimum: 40 years
Age maximum: 90 years
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetes.
Diabetes mellitus due to underlying condition

Intervention(s)

Intervention 1: Control group: The first intervention group includes people who use nylon thread to close their wounds after knee replacement surgery. In the first group, surgical wound closure using 2-0 nylon thread (Supalon), monofilament with polyamide-6, which is produced by Supa company in Iran, will be done in a simple interrupted manner. Skin closure will be done at a 45-degree knee bend angle. Intervention 2: Intervention group: This group includes people whose wounds will be closed with skin staples after knee joint replacement surgery. In this group, surgical wound closure will be performed using a special covidin skin surgical stapler (Appose ULC 35W).

Primary Outcome(s)

Wound infection. Timepoint: The evaluation of the results of the patient's wound in terms of the rate of wound infection will be followed up and recorded 2 to 8 weeks after the operation. Method of measurement: Surgical wound infection checklist.

Wound dehiscence. Timepoint: The evaluation of the results of the patient's wound in terms of the rate of wound dehiscence will be followed up and recorded 2 to 8 weeks after the operation. Method of measurement: Surgical wound dehiscence checklist.

Source(s) of Monetary Support

Shiraz University of Medical Sciences

Ethics review

Status: Approved
Approval date: 11/11/2023
Contact:

Ethics Committee of Shiraz University of Medical Sciences