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

NCT06220344 | Completed Phase 2 DMC

• 1 other identifier: HITEC-IMS-01-2022
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Signs of Wound Infection

  Presence of exudate, warmth, pus, erythema, dehiscence, contact bleeding, and any systemic sign like fever, rash, and myalgia.

  3rd day, 7th day, 15th day.

Study Arms (2)

Honey

EXPERIMENTAL

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

Biological: Honey Dressing

Aseptic Iodine

ACTIVE COMPARATOR

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

Drug: Iodine Dressing

Interventions

Honey Dressing 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.

Honey

Iodine Dressing 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.

Also known as: Iodine solution dressing

Aseptic Iodine

Eligibility Criteria

• Age: 12 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Patients with:
• Anemia
• BMI\>30
• Local Infection in wound area.
• Venous leg ulcers
• Diabetes
• Immunocompromised (Oncological patients)
• Patient under negative pressure therapy

Sponsors & Collaborators

• HITEC-Institute of Medical Sciences: lead

Study Sites (1)

Heavy Industry Taxila Hospital

Rawalpindi, Punjab Province, 407070, Pakistan

Location

MeSH Terms

Conditions

Wound Infection; Surgical Wound

Condition Hierarchy (Ancestors)

Infections; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: House Officer Neurosurgery

Study Record Dates

• First Submitted: January 14, 2024
• First Posted: January 23, 2024
• Study Start: December 2, 2022
• Primary Completion: March 3, 2023
• Study Completion: March 3, 2023
• Last Updated: January 25, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)