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.: PACTR202107584849418 Date of Approval: 16/07/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Management of wound blisters following Carpet viper envenomation in northeastern Nigeria
Official scientific title De-blister versus not-de-blister of bite wound blisters following Carpet viper envenomation in northeastern Nigeria: a proof of concept study
Brief summary describing the background and objectives of the trial Carpet viper is responsible for at least 66% of snakebite envenoming in northeastern Nigeria with the significant number of the patients presenting with blister 32.8%. It has been hypothesized that venom antigen and inflammatory chemicals in blister fluid might have a depot effect and through gradual release might lead to persistent of poisoning and poor outcome. Antivenom when administered intravenously leads to neutralization and decline of venom antigen level, repletion or normalization of clotting factors, INR, 20WBCT, and resolution of symptoms, however, its diffusion and bioavailability in the blister fluid remain poorly understood. We have shown in a preliminary study that the 33% of SBE patients who present with blisters have poorer outcomes than those without blisters. Therefore, it is hypothesized that deblistering of blister wounds may mitigate the depot effect and subsequently improve on morbidity and mortality. The aims of the study therefore, are to; 1. Understand the pharmacokinetics of venom proteins and antivenom IgG in blister fluid and sera. 2. To determine whether de-roofing versus not-de-roofing of bite wound blisters leads to better outcome.
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,Skin and Connective Tissue Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/08/2021
Actual trial start date 01/08/2021
Anticipated date of last follow up 31/01/2022
Actual Last follow-up date 30/01/2022
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 80
Recruitment status Not yet recruiting
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 Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Deblistering of wound blisters Not applicable Through hospital stay In the study arm, patients that present with blister/s following Carpet viper envenoming will be deblistered through aspiration by inserting the bevel of the needle at the base of the blister. Deroofing will be avoided. 40
Control Group No intervention At discharge No intervention 40 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Carpet viper envenomed patient with evidence of incoagulable blood in the 20minutes Whole Blood Clotting Test (20WBCT). 2- Mild to Moderately envenomed patient. 1- Severely envenomed patient 2- Unconscious patients 3- Children less than 12 years 4- Patients with severe delayed gangrenous body part 5- Other severe co-morbidities 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 12 Year(s) 80 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
No 17/06/2021 Bayero University Kano. College of Health Sciences Research Ethics Committee.
Ethics Committee Address
Street address City Postal code Country
College of Health Science, Bayero University Kano. New Hospital Road, Aminu Kano Teaching Hospital. Kano 70001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Effect of de-blister on mortality and morbidity following Carpet viper envenoming. At hospital discharge.
Secondary Outcome Complications of an intact blister and de-blistered wound e.g. infection, bleeding., pain, gangrene, compartment syndrome, amputation At discharge
Secondary Outcome Length of hospital stay At discharge
Secondary Outcome Vials of antivenom needed to restore clotting At discharge
Secondary Outcome Cost of care At discharge
Secondary Outcome ELIZA kinetics of venom Ag/Ab in blister At discharge
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kaltungo Snakebite Treatment Center Kaltungo, Gombe State Gombe Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Bayero University Kano Bayero University Kano, Gwarzo Road, Kano State. Kano Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Bayero University Kano BUK Road, Kano. Kano 70001 Nigeria University
COLLABORATORS
Name Street address City Postal code Country
Abdulrazaq Garba Habib Bayero University Kano, Gwarza Road. Kano Nigeria
Bashir Muhammad Dansanda New Hospital Road, Aminu Kano Teaching Hospital Kano Nigeria
Saidu Balla Abubakar Kaltungo town, Kaltungo Local Government Area Gombe Nigeria
Hadiza Lawan Department of Medical Laboratory Science, New Hospital Road, Aminu Kano Teaching Hospital Kano Nigeria
Muhammad Sulaiman Kaltungo Snakebite Hospital, Kaltungo. Gombe Nigeria
Agom Dauda Kaltungo Snakebite Hospital, Kaltungo. Gombe Nigeria
Bashir AZ Chedi Faculty of Pharmaceutical Sciences, Gwarzo Road Kano Nigeria
Abdulmajid Yakubu Department of Public Health, New Hospital Road, Aminu Kano Teaching Hospital Kano Nigeria
Muhammad Hamza Bayero University Kano, Gwarzo Road Kano Nigeria
Abdulhakim Dayyabu Kano State Ministry of Health Kano Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Garba Iliyasu ilyasug@yahoo.com +23408033371017 New Hospital Road, Aminu Kano Teaching Hospital, Kano
City Postal code Country Position/Affiliation
Kano 70001 Nigeria Infectious Disease and Tropical Medicine Unit College of Health Sciences Bayero University Kano
Role Name Email Phone Street address
Public Enquiries Abdulrazaq G Habib abdulrazaq_habib@yahoo.co.uk +23408036921712 New Hospital Road, Department of Medicine, Aminu Kano Teaching Hospital
City Postal code Country Position/Affiliation
Kano 70001 Nigeria Infectious Disease and Tropical Medicine Unit Department of Medicine Bayero University kano
Role Name Email Phone Street address
Scientific Enquiries Garba Iliyasu ilyasug@yahoo.com +23408033371017 New Hospital Road, Aminu Kano Teaching Hospital
City Postal code Country Position/Affiliation
Kano 70001 Nigeria Infectious Disease and Tropical Medicine Unit Department of Medicine College of Health Science Bayero University Kano
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All relevant individual participant data will be shared according to WHO requirement. These data will include; study protocol, informed consent, and summary of results. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol The relevant IPD will be available through out the duration of the study and 2 years after the completion of the study IPD will be available under on request in a controlled basis. The request should be channeled to the principle investigation and there will be approval from the Research Ethics Committee that approved the study.
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