Neck AbscessNCT06562257
Honey as an Adjunctive Wound Care Modality for Deep Neck Space Abscess
A study testing Honey and PHMB Solution in people with Neck Abscess, run by Gadjah Mada University at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neck Abscess
- What is being tested?
- Honey and PHMB Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteIndonesia
- Study dates
- 19 Jun 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Deep neck abscess patients over 18 years old with or without comorbidities except for malignant diseases
Who cannot join
- Patients who refused intervention
- Patients who underwent vacuum-assisted closure (VAC)
- Patients with incomplete medical records
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Dr. Sardjito General Hospital
Yogyakarta, D.I Yogyakarta, 55281
About this study
Official title: Topical Honey as Adjunctive Therapy to Standard Dressing in Deep Neck Abscess: A Single-Blind Randomized Controlled Trial
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.
Read the detailed description
Deep neck abscess is one of the diseases in the field of otorhinolaryngology-head and neck surgery that has high morbidity, mortality, and costs. Management of deep neck abscesses involves incision and drainage, abscess exploration, systemic administration of broad-spectrum antibiotics, management of comorbid factors, and postoperative wound care until healing. Standard dressing for wound care has been time-consuming and costly. Honey is one type of dressing modality that has been widely used in wound care for various parts of the body and diseases. Honey is expected to be a more cost-efficient treatment modality that supports accelerated wound healing, leading to better outcomes and cost savings.
The research design used is a single-blind randomized controlled trial (RCT), where researchers randomly assign one intervention to respondents to compare the effects of honey and Prontosan on the wound healing process. The population and sample of the study include all patients with deep neck abscesses treated at Dr. Sardjito General Hospital, the teaching hospital of the Faculty of Medicine Gadjah Mada University and other hospitals equipped with board-certified Otorhinolaryngologists. The participants in the control group were treated with standard dressing, while participants in the study group were treated with standard dressing along with honey dressing.
- Conditions
- Neck Abscess
- Being tested
- Honey, PHMB Solution
- Keywords
- Deep neck space infection, Deep neck space abscess, Wound healing, Honey dressing, Bates Jensen Wound Assessment Tool
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HoneyOther
Also called Nusantara Honey
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.
PHMB SolutionOther
Also called Prontosan
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: PHMB Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Assessment
The wound was assessed by the research assistant using the Bates-Jensen Wound Assessment Tool
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 consist of blood pressure (mmHg), heart rate per minute, respiration rate per minute, temperature (°C), and saturation (%) which are useful for monitoring patients in this study.
Measured: Vital Signs were performed everyday throughout patient's admission in the wards.
Blood Gas Analysis
Blood gas analysis showed by measuring pH, pCO2 (mmHg), HCO3 (mmol/L), pO2 (mmHg), and BE (mmol/L) status.
Measured: Blood gas analysis were performed throughout patient's admission in the wards.
Complete Blood Count (CBC)
Complete blood count performed included, Hemoglobin (g/dL), RBC (10^6/uL), WBC (10^3/uL), Platelet (10^3/uL), and blood type.
Measured: CBC were performed throughout patient's admission in the wards.
Liver Function Tests
Liver function tests typically include SGOT (U/L), SGPT (U/L), bilirubin serum (mg/dL), INR (international normalized ratio), prothrombin time (PT) and activated partial thromboplastine time (APTT) in second.
Measured: Liver function tests were performed throughout patient's admission in the wards.
Kidney Function Tests
Kidney function test such as albumin (g/dL), BUN (mg/dl), creatinine serum (mg/dL), uric acid (mg/dL) and electrolytes (mmol/L): sodium, potassium, chloride .
Measured: Kidney function tests were performed throughout patient's admission in the wards.
Blood Glucose Test
A blood glucose test measure the amount of glucose in patient blood to hel diagnose or monitor diabetes either as a comorbidity or not ny doing a finger-picker test or a blood draw from patient vein
Measured: Blood glucose test was performed throughout patient's admission in the wards.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start19 Jun 2024
- Primary completion30 Jun 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neck AbscessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gadjah Mada University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DIAN PARAMITA WULANDARI, Gadjah Mada University
- Investigators
- Dian Paramita Wulandari, Principal investigator, Universitas Gadjah Mada - Dr. Sardjito General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06562257
- Sponsor's protocol ID
- KE/FK/0668/EC/2024
- Status last verified
- Jun 2026
- First submitted
- 14 Aug 2024
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40810438
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Honey as Adjunctive Therapy to Standard Dressing in Deep Neck Abscess: A Single-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06562257
- Acronym / sponsor ID
- KE/FK/0668/EC/2024
- Conditions
- Neck Abscess
- Keywords
- Deep neck space infection, Deep neck space abscess, Wound healing, Honey dressing, Bates Jensen Wound Assessment Tool
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Gadjah Mada UniversityUniversity, hospital or other
- Study start
- 19 Jun 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Deep neck abscess is one of the diseases in the field of otorhinolaryngology-head and neck surgery that has high morbidity, mortality, and costs. Management of deep neck abscesses involves incision and drainage, abscess exploration, systemic administration of broad-spectrum antibiotics, management of comorbid factors, and postoperative wound care until healing. Standard dressing for wound care has been time-consuming and costly. Honey is one type of dressing modality that has been widely used in wound care for various parts of the body and diseases. Honey is expected to be a more cost-efficient treatment modality that supports accelerated wound healing, leading to better outcomes and cost savings.
The research design used is a single-blind randomized controlled trial (RCT), where researchers randomly assign one intervention to respondents to compare the effects of honey and Prontosan on the wound healing process. The population and sample of the study include all patients with deep neck abscesses treated at Dr. Sardjito General Hospital, the teaching hospital of the Faculty of Medicine Gadjah Mada University and other hospitals equipped with board-certified Otorhinolaryngologists. The participants in the control group were treated with standard dressing, while participants in the study group were treated with standard dressing along with honey dressing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group (Standard Dressing and Honey) | Experimental | Other: Honey, Other: PHMB SolutionIn 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. |
| Control Group (Standard Dressing) | Active comparator | Other: PHMB SolutionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Deep neck abscess patients over 18 years old with or without comorbidities except for malignant diseases
Key exclusion criteria (3 listed)
- Patients who refused intervention
- Patients who underwent vacuum-assisted closure (VAC)
- Patients with incomplete medical records
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HoneyAlso: Nusantara HoneyHoney 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. | Other | Treatment Group (Standard Dressing and Honey) |
| PHMB SolutionAlso: ProntosanPHMB 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. | Other | Control Group (Standard Dressing), Treatment Group (Standard Dressing and Honey) |
Primary outcome
Wound Assessment
Time frame: BWATs was measured on the first, seventh, and fourteenth days from abscess incision.
The wound was assessed by the research assistant using the Bates-Jensen Wound Assessment Tool
Wound Measurements
Time frame: The wound was measured on the first, seventh, and fourteenth days from abscess incision.
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.
Bacterial Colony
Time frame: Pus aspiration was performed by the resident doctor who conducted the dressing on the first and fourteenth days from abscess incision
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.
Cytokine and Growth Factor Expression
Time frame: Tissue sampling was performed by the resident doctor who conducted the dressing on the first and fourteenth days from abscess incision
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.
6 secondary outcomes
Vital Sign Examinations
Time frame: Vital Signs were performed everyday throughout patient's admission in the wards.
Blood Gas Analysis
Time frame: Blood gas analysis were performed throughout patient's admission in the wards.
Complete Blood Count (CBC)
Time frame: CBC were performed throughout patient's admission in the wards.
Liver Function Tests
Time frame: Liver function tests were performed throughout patient's admission in the wards.
Kidney Function Tests
Time frame: Kidney function tests were performed throughout patient's admission in the wards.
Blood Glucose Test
Time frame: Blood glucose test was performed throughout patient's admission in the wards.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Derived from this study: PubMed 40810438Wulandari 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dian Paramita Wulandari principal investigator
Universitas Gadjah Mada - Dr. Sardjito General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Honey and PHMB Solution in people with Neck Abscess, run by Gadjah Mada University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Assessment (time frame: BWATs was measured on the first, seventh, and fourteenth days from abscess incision.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06562257, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.