Honey as A Wound Care Modality in Treating Deep Neck Space Abscess

NCT06562257 | Recruiting DMC

• 1 other identifier: KE/FK/0668/EC/2024
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the effectiveness of honey as a treatment for deep neck space abscesses, comparing it to standard wound care methods. Conducted as a randomized clinical trial, it aims to determine whether honey can offer a viable alternative or improvement in managing this condition. The research assesses outcomes related to healing, infection control, and overall patient recovery.

Conditions

Neck Abscess

Keywords

Deep neck space infection; Deep neck space abscess; Wound healing; Honey dressing; Bates Jensen Wound Assessment Tool

Outcome Measures

Primary Outcomes (4)

• Wound Assessment

  The wound was assessed by the research assistant using the Bates-Jensen Wound Assessment Tool

  BWATs was measured on the first, seventh, and fourteenth days from abscess incision.

• Wound Measurements

  Wound measurements included length, width, and depth in cm, with the largest width and length used for data to report wound area in cm\^2. The wound depth was measured using a probe perpendicular to the wound's length and width.

  The wound was measured on the first, seventh, and fourteenth days from abscess incision.

• Bacterial Colony

  Bacterial culture results and the number of bacterial colonies served as indicators of infection improvement. Swabs from the wound bed were sent to the Microbiology laboratory.

  Pus aspiration was performed by the resident doctor who conducted the dressing on the first and fourteenth days from abscess incision

• Cytokine and Growth Factor Expression

  Immunopathological evaluation of wound healing involved tissue samples sent to the Anatomical Pathology laboratory for analysis of IL-1, TNF-α, and VEGF expression. Tissue sampling was performed using nasopharyngeal biopsy forceps, and the preserved tissue was sent for analysis.

  Tissue sampling was performed by the resident doctor who conducted the dressing on the first and fourteenth days from abscess incision

Secondary Outcomes (6)

• Vital Sign Examinations

  Vital Signs were performed everyday throughout patient's admission in the wards.

• Blood Gas Analysis

  Blood gas analysis were performed throughout patient's admission in the wards.

• Complete Blood Count (CBC)

  CBC were performed throughout patient's admission in the wards.

• Liver Function Tests

  Liver function tests were performed throughout patient's admission in the wards.

• Kidney Function Tests

  Kidney function tests were performed throughout patient's admission in the wards.

Study Arms (2)

Treatment Group (Standard Dressing and Honey)

EXPERIMENTAL

In the treatment group, we combined standard procedures with the application of Nusantara Honey. A 120 cm gauze roll was soaked in a bowl containing 12 cc of Nusantara Honey for precisely 1 minute until saturation. Once the wound bed had risen sufficiently, the honey-soaked gauze was applied and covered with sterile gauze.

Other: Honey; Other: PHMB Solution

Control Group (Standard Dressing)

ACTIVE COMPARATOR

The control group adhered to the established standard operating procedure (SOP) at the Larynx Pharynx subdivision of Dr. Sardjito Hospital. This protocol involved several steps of wound debridement, saline irrigation, gauze roll application, and Prontosan administration.

Other: PHMB Solution

Interventions

Honey OTHER

Honey has a long-standing reputation for promoting wound healing and offers a more economical treatment modality. Nusantara Honey, a GMP-certified product available on the market, met our criteria for quality and safety.

Also known as: Nusantara Honey

Treatment Group (Standard Dressing and Honey)

PHMB Solution OTHER

PHMB is an antimicrobial polymer that is effective against intracellular and biofilm forms of S. aureus. PHMB is quite effective in the treatment of wounds in deep neck abscesses.

Also known as: Prontosan

Control Group (Standard Dressing); Treatment Group (Standard Dressing and Honey)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Deep neck abscess patients over 18 years old with or without comorbidities except for malignant diseases

You may not qualify if:

• Patients who refused intervention
• Patients who underwent vacuum-assisted closure (VAC)
• Patients with incomplete medical records

Sponsors & Collaborators

• Gadjah Mada University: lead

Study Sites (1)

Dr. Sardjito General Hospital

Yogyakarta, D.I Yogyakarta, 55281, Indonesia

RECRUITING

Related Publications (1)

• Wulandari DP, Subronto YW, Surono A. Honey as a Wound Care Modality in Treating Deep Neck Space Abscesses: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Aug 14;14:e75475. doi: 10.2196/75475.

  PMID: 40810438 DERIVED

MeSH Terms

Interventions

Honey

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Dian Paramita Wulandari

  Universitas Gadjah Mada - Dr. Sardjito General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dian Paramita Wulandari

CONTACT

+62 811259775; dian.paramita.w@ugm.ac.id

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both patients and the principal investigator will remain blinded throughout the completed treatment period. Treatment allocations will only be disclosed after the final database lock. The patients are primarily handled by a principal investigator and resident doctor who is in charge of the evaluation of inclusion or exclusion criteria, adverse events, relapses, and side effects
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 20, 2024
• Study Start: June 19, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)