Honey Dressing - A Preventive Procedure for Post-Surgical Site Infection.

NCT ID: NCT06220344

Last Updated: 2024-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-02
• Study Completion Date: 2023-03-03

Brief Summary

The goal of this clinical trial is to compare the wound healing in the participants who underwent the clean surgical procedure, by applying honey dressing and common Iodine solution dressing, participants will have no other co-morbidities like Diabetes, Anemia, etc. which can make the results biased. The main questions it aims to answer are:

• Do the iodine solutions are enough to counter the infections caused by resistant strains of bacteria?
• What is the efficacy and efficiency of honey dressing in wound care?

Participants will be tasked to

• Ensure strict follow-up in the hospital dressing room
• Half of the participants will apply common iodine solution dressing and the other half will be applied honey dressing.

Researchers will compare Iodine dressing (Control group) with Honey dressing (Experimental group) to see if Honey dressing is better in the prevention of post-surgery wound infection and if it is cost-efficient and its efficacy.

Conditions

Wound Infection; Wound Dehiscence; Wound Bleeding; Wound Surgical

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Honey

Participants will get honey dressings in their follow-up visits to the dressing room.

Group Type: EXPERIMENTAL

Honey Dressing

Intervention Type: BIOLOGICAL

Honey Dressing will be applied from the 1st Post-Op day till the fully healed wound, which is described as no dehiscence, no exudate, no warmth, and sutures removed.

Aseptic Iodine

Participants will get iodine solution dressings in their follow-up visits to the dressing room.

Group Type: ACTIVE_COMPARATOR

Iodine Dressing

Intervention Type: DRUG

Iodine Dressing will be applied from the 1st Post-Op day till the fully healed wound, which is described as no dehiscence, no exudate, no warmth, and sutures removed.

Interventions

Honey Dressing

Honey Dressing will be applied from the 1st Post-Op day till the fully healed wound, which is described as no dehiscence, no exudate, no warmth, and sutures removed.

Intervention Type: BIOLOGICAL

Iodine Dressing

Iodine Dressing will be applied from the 1st Post-Op day till the fully healed wound, which is described as no dehiscence, no exudate, no warmth, and sutures removed.

Intervention Type: DRUG

Other Intervention Names

Iodine solution dressing

Eligibility Criteria

Inclusion Criteria

Patients with sterile/clean post-surgical wounds are admitted in general surgery, neurosurgery, orthopedic, and gynecology wards and require follow-up dressings.

Exclusion Criteria

1. Patients with:

• Anemia
• BMI>30
• Local Infection in wound area.
• Venous leg ulcers
• Diabetes
• Immunocompromised (Oncological patients)

2. Patient under negative pressure therapy

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HITEC-Institute of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Syed Muhammad Ali Haider

House Officer Neurosurgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Heavy Industry Taxila Hospital

Rawalpindi, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

HITEC-IMS-01-2022

Identifier Type: -

Identifier Source: org_study_id