A study to determine the rate of infection of wounds from abdominal operations across Nigeria
| ISRCTN | ISRCTN14422305 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14422305 |
- Submission date
- 05/07/2024
- Registration date
- 25/07/2024
- Last edited
- 29/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Infection occurring on the wound following operations on the abdomen of patients can be associated with increased costs, prolonged stay in the hospital, and other harm to the patient. It increases healthcare costs for society, which is unbearable in poorer countries such as Nigeria. For this and many other reasons, many interventions are carried out for prevention.
In Nigeria, we do not have reliable national data about these infections, making it difficult to plan on how to reduce them. This study is being carried out by a collaborative group of surgeons spanning 54 hospitals in 32 states of Nigeria.
Who can participate?
All children and adult patients undergoing emergency or elective abdominal operations
What does the study involve?
After any abdominal operation on children and adults, surgeons will purposefully inspect the wound when discharging patients from the hospital and on day 30 after the operation. They will record cases that have infections and identify conditions associated with their infections
What are the possible benefits and risks of participating?
None
Where is the study run from?
Association of Surgeons of Nigeria
When is the study starting and how long is it expected to run for?
December 2023 to October 2024
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Prof. Adewale Adisa, ao.adisa@oauife.edu.ng
Contact information
Public, Scientific, Principal Investigator
Department of Surgery
Obafemi Awolowo University
Ile-Ife
220005
Nigeria
 ORCID ID |
0000-0003-1927-3992 |
|---|---|
| Phone | +234 8033889425 |
| ao.adisa@oauife.edu.ng |
Study information
| Study design | Prospective observational multicenter study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Surgical site infection following abdominal operations: a prospective, multicenter cohort study across Nigeria |
| Study acronym | Nigeria SSI study |
| Study objectives | Surgical site infection is high following abdominal operations across Nigeria |
| Ethics approval(s) |
Approved 21/12/2023, National Health Research Ethics Committee of Nigeria (Federal Ministry of Health, Abuja, 900211, Nigeria; +234 095238367; deskofficer@nhrec.net), ref: NHREC/01/01/2007-21/12/2023 |
| Health condition(s) or problem(s) studied | Abdominal operations |
| Intervention | Eligible patients will be consented for recruitment. Their demographic data and operation details will be recorded immediately after operation. Wounds will be observed for evidence of infection on the day of discharge and on day 30 after the operation. Bacteria cultured from any infected wounds will be recorded. Follow up and observations ends on day 30. |
| Intervention type | Other |
| Primary outcome measure | Surgical site infection (SSI) 30 days post operation, defined according to Centre for Disease Control criteria |
| Secondary outcome measures | Measured using patient records: 1. Profile of organisms detected from wound swab 2. Patient-reported time taken to return to normal activities 3. Patient-reported time taken to return to work. 4.. Mortality at day 30 after operation and its relationship to SSIs |
| Overall study start date | 21/12/2023 |
| Completion date | 31/10/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | All |
| Lower age limit | 1 Month |
| Upper age limit | 90 Years |
| Sex | Both |
| Target number of participants | 2000 |
| Total final enrolment | 2400 |
| Key inclusion criteria | 1. Patient able and willing to provide written informed consent (signature or a fingerprint) or assent from parent or guardian 2. All children and adult patients undergoing emergency or elective abdominal operations 3. Benign, malignant and trauma cases can all be included 4. Abdominal incision with an anticipated clean-contaminated, contaminated or dirty surgical wound 5. Anticipated abdominal incision of 3cm in children or 5cm or more in adults 6. Both open surgery and laparoscopic surgery can be included 7. All secondary, tertiary, public, and privately funded hospitals that perform abdominal surgeries will be eligible |
| Key exclusion criteria | 1. Abdominal operations with clean surgical wound, such as simple hernia repair 2. Patients undergoing caesarean section will be excluded 3. Patients who are unable to complete follow-up at post-operative day 30 4. Patient already enrolled in another trial assessing surgical site infection |
| Date of first enrolment | 01/05/2024 |
| Date of final enrolment | 31/08/2024 |
Locations
Countries of recruitment
- Nigeria
Study participating centres
Ile-Ife
220005
Nigeria
Lagos
2000
Nigeria
Nnnewi
888000
Nigeria
Ilorin
111000
Nigeria
Kano
30245
Nigeria
Sponsor information
University/education
Department of Surgery, LUTH
Lagos
100254
Nigeria
| Phone | +234 08095482418 |
|---|---|
| adesojiademuyiwa@yahoo.co.uk | |
| Website | http://www.ason-ngr.org/ |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/03/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | We would publish the result in an international, peer-reviewed, scientific journal. The Nigerian Federal Ministry of Health will have the results presented. We will also present this at Nigeria surgical meetings |
| IPD sharing plan | The dataset generated and or analyzed during this study will be available upon request from ao.adisa@oauife.edu.ng |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 11/07/2024 | No | No |
Additional files
Editorial Notes
05/07/2024: Trial's existence confirmed by National Health Research Ethics Committee of Nigeria.
