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.: PACTR202103828782352 Date of Approval: 26/03/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Antibiotic coverage for abdominal surgical procedures: A comparative study between two regimens and wound outcome.
Official scientific title Antibiotic coverage for abdominal surgical procedures: A comparative study between two regimens and wound outcome.
Brief summary describing the background and objectives of the trial Surgical site infections (SSI) are major complications after surgical procedures and it has enormous impact on quality of life and contribute substantially to the financial cost of patient care especially where hospital stay is prolonged in order to treat the infections.The cost implication of treating a patient with surgical site infections have been estimated to be double to the cost of treating a patient without surgical site infections
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied surgical wound infection
Purpose of the trial Treatment: Drugs
Anticipated trial start date 03/08/2020
Actual trial start date 07/12/2020
Anticipated date of last follow up 31/05/2021
Actual Last follow-up date 15/03/2022
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants) 290
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 Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group treatment intravenous ampiclox 500mg, gentamicin 80mg and metronidazole 500mg 5 days A combination of with first dose given at induction of anaesthesia and continued till the second postoperative day of surgery, and thereafter changed to oral form to complete a five day course. However, the gentamicin will be continued as parenteral to complete the five day course. 150 Active-Treatment of Control Group
Experimental Group Control IV ceftriaxone 1g daily 5 days Control group; intravenous ceftriaxone 1g given at induction of anaesthesia and continued as daily intravenous injection till the fifth day of surgery. 150
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All women scheduled for various types of abdominal surgeries in the Obstetrics and Gynaecology wards. Patient that refuse to give consent Patients who are on any form of antibiotics fourteen days before the surgery. 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) 16 Year(s) 80 Year(s) Female
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 20/07/2020 Olabisi Onabanjo University Teaching Hospital Health research ethics committee
Ethics Committee Address
Street address City Postal code Country
hospital road Sagamu 223401 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome prevalence, pattern of microbial isolate and compare the cost implication of two peri-operative antimicrobial regimen used in prophylaxis of surgical site infection in obstetrics and gynaecology wards. 4 weeks post operation
Secondary Outcome The cost implication of two peri-operative antimicrobial regimen used in prophylaxis of surgical site infection in obstetrics and gynaecology wards. 4 weeks post operation
Secondary Outcome Microorganism Growth 5 days post surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Obstetrics and gynecology Olabisi Onabanjo University teaching Hospital Hospital road Sagamu Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Prof SuleOdu AO Hospital road Sagamu Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor All researchers involved in the study Hospital Road Sagamu Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Prof Sule Odu AO Hospital Road Sagamu Nigeria
Prof Olatunji AO Hospital Road Sagamu Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adewale Sule Odu adewalesuleodu@yahoo.com 2348034098564 hospital
City Postal code Country Position/Affiliation
sagamu Nigeria OOUTH
Role Name Email Phone Street address
Public Enquiries Adeniyi Akiseku niyikepler@yahoo.com 2348036103799 Hospital Road
City Postal code Country Position/Affiliation
Sagamu Nigeria OOUTH
Role Name Email Phone Street address
Scientific Enquiries Adetola Olatunji detolatunji@gmail.com 2348033189157 Hospital Road
City Postal code Country Position/Affiliation
Sagamu Nigeria OOUTH
Role Name Email Phone Street address
Scientific Enquiries Peter Adefuye peteradefuye2000@gmail.com 2348108156752 Hospital Road
City Postal code Country Position/Affiliation
Sagamu Nigeria OOUTH
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes summary results or link will be shared once the study is completed Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 2 years Open
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