Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202504577239686 Date of Registration: 24/04/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A Comparative Study of The Efficacy of Honey and Eusol in the Management of Traumatic Maxillofacial Soft Tissue Injuries at a Tertiary Hospital in Kaduna State, Nigeria.
Official scientific title A Comparative Study of The Efficacy of Honey and Eusol in the Management of Traumatic Maxillofacial Soft Tissue Injuries at a Tertiary Hospital in Kaduna State, Nigeria.
Brief summary describing the background and objectives of the trial This was a prospective, interventional and comparative study aimed at comparing the efficacy of honey and EUSOL, in the management of traumatic maxillofacial soft tissue wounds. It was carried out at the Department of Oral and Maxillofacial Surgery, Ahmadu Bello University Teaching Hospital, Shika-Zaria, Kaduna State, Nigeria, between December 18th 2019 and October 31st 2020. An ethical approval was obtained from the Health and Research Ethics Committee (HREC) of the hospital before commencement.The objectives of this study are: 1. To compare pain scores following dressings of traumatic maxillofacial wounds with honey and EUSOL, using the numerical rating scale (Appendix I). 2. To compare the time it takes for the wounds to heal following dressing with honey and EUSOL. 3. To compare the quality of scar following dressings of traumatic maxillofacial wounds with honey and EUSOL, using the Patient and Observer Scar Assessment Scale .
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 19/11/2019
Actual trial start date 19/11/2019
Anticipated date of last follow up 31/10/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Allocation Sequence/Code was not concealed Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Wound dressing 21 days Wound were dressed either using honey or EUSOL 40 Active-Treatment of Control Group
Experimental Group Honey dressing 1 - 2mls 12 hrly 21 days The honey was smear over the wound by the trained nurse 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Only consenting patients of 10 to 70 years of age were included in this study. 2. All consecutive patients presenting to our facility with traumatic maxillofacial wounds of less than 48 hours in duration. 3. Only traumatic maxillofacial soft tissue wounds measuring 1 cm to 20 cm (in its largest diameter) were included in this study. Patients presenting with comorbid conditions known to affect wound healing e.g. HIV/AIDS, Diabetes, and anemia. 2. Unconscious patients and those presenting with cognitive pathologies. 3. Patients who have undergone radiotherapy to the maxillofacial region. 4. Patients on steroid therapy. 5. Traumatic soft tissue injuries that can be closed primarily. 6. Extraoral wounds communicating with oral cavity. 7. Deep avulsive injuries with bony exposure. 8. Animal bite injuries. 9. Known allergy to either honey or EUSOL. Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 10 Year(s) 70 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 12/10/2020 ABUTH HREC
Ethics Committee Address
Street address City Postal code Country
Sokoto Road Zaria 006 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Patients level of pain 21 days intra-operative
Secondary Outcome Patients satisfaction 21 days and beyond intra and post operative
Primary Outcome wound healing with epitheliazation 21 days intra operative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
AHMADU BELLO UNIVERSITY TEACHING HOSPITAL SOKOTO ROAD ZARIA Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr BOULAMA G MA Sokoto Road Zaria Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Prof B Fomete Sokoto road Zaria Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr Goni ABM Sokoto Road Zaria Nigeria
Prof Ajike SO Sokoto Road Zaria Nigeria
Prof Ibrahim A Sokoto Road Zaria Nigeria
Prof Adebayo ET Kanta Road Kaduna Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adamu Goni a.goniboulama@gmail.com +22792030202 Tchangareye, Koira Tegui
City Postal code Country Position/Affiliation
Niamey Niger Consultant
Role Name Email Phone Street address
Public Enquiries Benjamin Fomete benfometey@hotmail.com +2348034515494 Sokoto Road
City Postal code Country Position/Affiliation
Zaria Nigeria Consultant
Role Name Email Phone Street address
Scientific Enquiries Ezekiel Adebayo taiwo_adebayo@yahoo.com +2348033309149 kanta road
City Postal code Country Position/Affiliation
kaduna Nigeria Consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes the study is completed Study Protocol Raw data available for sharing with researchers and organizations open
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 07/04/2025
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 07/04/2025
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 15/04/2025 Title not to be in capital letter A COMPARATIVE STUDY OF THE EFFICACY OF HONEY AND EUSOL IN THE MANAGEMENT OF TRAUMATIC MAXILLOFACIAL SOFT TISSUE INJURIES AT A TERTIARY HOSPITAL IN KADUNA STATE, NIGERIA. A Comparative Study of The Efficacy of Honey and Eusol in the Management of Traumatic Maxillofacial Soft Tissue Injuries at a Tertiary Hospital in Kaduna State, Nigeria.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 15/04/2025 Title not to be in capital letter A COMPARATIVE STUDY OF THE EFFICACY OF HONEY AND EUSOL IN THE MANAGEMENT OF TRAUMATIC MAXILLOFACIAL SOFT TISSUE INJURIES AT A TERTIARY HOSPITAL IN KADUNA STATE, NIGERIA. A Comparative Study of The Efficacy of Honey and Eusol in the Management of Traumatic Maxillofacial Soft Tissue Injuries at a Tertiary Hospital in Kaduna State, Nigeria.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 08/04/2025 PACTR Admin 19 Nov 2019
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 15/04/2025 specification was missing Primary Outcome, Patients level of pain, 21 days Primary Outcome, Patients level of pain, 21 days intra-operative
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 15/04/2025 specification needed Secondary Outcome, Patients satisfaction, 21 days Secondary Outcome, Patients satisfaction, 21 days and beyond intra and post operative
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 15/04/2025 the specification was not there Primary Outcome, wound healing with epitheliazation, 21 days intra operative
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 15/04/2025 statement on sharing was not captured properly available Raw data available for sharing with researchers and organizations