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 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202103707607761 Date of Registration: 05/03/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title EFFECTIVENESS OF BIODRESS, HONEY AND POVIDON-IODINE OINTMENT ON ACUTE WOUNDS HEALING IN ENUGU STATE, NIGERIA: A RANDOMIZED CONTROLLED TRIAL
Official scientific title EFFECTIVENESS OF BIODRESS, HONEY AND POVIDON-IODINE OINTMENT ON ACUTE WOUNDS HEALING IN ENUGU STATE, NIGERIA: A RANDOMIZED CONTROLLED TRIAL
Brief summary describing the background and objectives of the trial Purpose of the Study The purpose of the study is to compare the outcome of acute wounds managed with Biodress, Honey and Povidone-iodine ointment after cleansing the wounds with normal saline (cleansing agent). The outcome parameters to be measured are the healing rate, presence of wound complications, ease of product use, cost of wound care, quality of life. Analysis: 1- Epithelisation/Healing- Wound diameter/size, Wound bed 2- Pain on presentation (during dressings) 3- Wound complications (infection, pruritus, edema, allergy) – using the Delphi approach 4- Cost of wound care – unit cost of the dressing materials (biodress, honey, povidone) as well as other materials (dressing packs, normal saline) 5- Ease of use – average time it takes to remove old dressings, and average time it takes to dress the wound. 6- Length of hospital stay 7- Quality of life - using WoundQOL (With permission from the authors) 8- Treatment failure
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning,Musculoskeletal Diseases,Skin and Connective Tissue Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Evidence-based practice looking out for effectiveness, complications as well as cost effectiveness
Anticipated trial start date 09/06/2020
Actual trial start date 15/06/2020
Anticipated date of last follow up 25/02/2021
Actual Last follow-up date 09/03/2021
Anticipated target sample size (number of participants) 42
Actual target sample size (number of participants) 42
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Biodress dressing changed alternate daily monitored for 6 weeks a moisture balanced dressing material 14
Control Group honey alternate daily dressing monitored from presentation to 6 weeks post injury honey for food. usually used in these centers for wound management. seeking for evidence 14 Dose Comparison
Control Group Povidone iodine ointment alternate daily dressing from presentation to 6 weeks post injury povidone iodine used for wound management 14 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Patients that will present with acute wounds at the facility during the study period. 2- Acute wounds of not more than 48 hours 3- Wounds with signs of colonization 4- Burn wounds 5- Patients with acute wounds who consent or their caregivers consented to participate in the study. Patients with acute wounds who are ill patients that have an underlying medical or surgical conditions that will interfere with wound healing (immunocompromised state, malignancy, uncontrolled diabetes, severe anaemia and hypoproteinemia), Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year 12 Month(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 08/08/2019 ESUT Teaching Hospital Ethics Commitee Board
Ethics Committee Address
Street address City Postal code Country
enugu enugu PMB 1030 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome parameter to be measured is wound closure. other parameters are the healing rate, presence of wound complications, ease of product use, cost of wound care, quality of life. weekly and finally at 6 weeks
Secondary Outcome other parameters are the healing rate, presence of wound complications, ease of product use, cost of wound care, quality of life. weekly and then at 6 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
accident and Emergency dept of both hospital. Enugu State University of Science and Technology Teaching Hospital and National Orthopaedic Hospital Enugu enugu enugu Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
MRS. ANETEKHAI CHINENYE J. ENUGU ENUGU Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor PHARMACIST AMARA CHIKWENDU MD. HEALTHLINE LIMITED ENUGU Nigeria PROVIDED THE BIODRESS FOR THE STUDY FREE
COLLABORATORS
Name Street address City Postal code Country
DR ONAH IFEANYI NATIONAL ORTHOPAEDIC HOSPITAL ENUGU ENUGU Nigeria
DR MBAH UC ENUGU STATE UNIVERSITY OF SCINECE AND TECHNOLOGY/ NOHE ENUGU Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator CHINENYE ANETEKAHI NEE OGBOGU nenyeogbogu@gmail.com +2348030854835 8 federal avenue extension trans ekulu enugu
City Postal code Country Position/Affiliation
enugu Nigeria academic UNN
Role Name Email Phone Street address
Public Enquiries ONAH IFEANYI anyionah@yahoo.com +2348032791048 NOHE
City Postal code Country Position/Affiliation
ENUGU Nigeria CHIEF CONSULTANT PLASTIC SURGEON NOHE AND ESUTTH
Role Name Email Phone Street address
Scientific Enquiries AGNES ANARADO agnes.anarado@unn.edu.ng +2348068178477 UNEC
City Postal code Country Position/Affiliation
ENUGU Nigeria PROFESSOR OF NURSING UNEC AND SUPERVISOR
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data will be made available to individual participant. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be made available. The study Protocol will be made available too following publication. Data will be available for researchers who provide a methodologically sound proposal. After 6months the data will be available in out University’s data warehouse but without investigator support other than deposited metadata. Study Protocol after publication (6 months) university's data ware house
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information