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

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

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.

Study Overview

• Status: Completed
• Conditions: Wound Infection; Wound Dehiscence; Wound Surgical; Wound Bleeding
• Intervention / Treatment: Biological: Honey Dressing; Drug: Iodine Dressing

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Rawalpindi, Punjab, Pakistan, 407070
      • Heavy Industry Taxila Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Honey; Participants will get honey dressings in their follow-up visits to the dressing room.	Biological: 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.
Active Comparator: Aseptic Iodine; Participants will get iodine solution dressings in their follow-up visits to the dressing room.	Drug: 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.; Other Names: Iodine solution dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: HITEC-Institute of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2022
• Primary Completion (Actual): March 3, 2023
• Study Completion (Actual): March 3, 2023

Study Registration Dates

• First Submitted: January 14, 2024
• First Submitted That Met QC Criteria: January 14, 2024
• First Posted (Actual): January 23, 2024

Study Record Updates

• Last Update Posted (Actual): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Infections; Communicable Diseases; Wounds and Injuries; Surgical Wound; Surgical Wound Infection; Wound Infection; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Trace Elements; Micronutrients; Iodine
• Other Study ID Numbers: HITEC-IMS-01-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No