Surgery
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Patients with at least one abdominal incision that is =5cm (open or laparoscopic extraction site), with an anticipated clean-contaminated, contaminated, or dirty surgical wound. Definitions and examples of contamination are given in Table 1. - Patients undergoing emergency (surgery on an unplanned admission) or elective (surgery on a planned admission) operations. - Any operative indication for abdominal surgery (excluding caesarean section; see exclusion criteria). - Patient able and willing to provide written informed consent (signature or a fingerprint) prior to surgery (including emergency cases). - Patients aged XX years and over. (This criteria MUST be made country-specific. Each country will decide the lower (and upper, if applicable according to local regulations age limit for the trial. This will be dependent on country-specific regulatory approvals. Age eligibility will vary by country. The lowest possible age of eligibility is 5 years old in all territories.)
Exclusion criteria
Exclusion criteria: - Patient unable to complete post-operative follow-up (i.e., will not be contactable after discharge). - Patients undergoing clean surgical procedures. - Patients undergoing an obstetrics procedure, including caesarean sections.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surgical site infection within 30-days after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| SSI at or prior to discharge from hospital ;Mortality (and likely cause);Length of hospital stay for index admission ;Readmission;Return to normal activities (e.g. work, school, or family duties) ;Unplanned wound opening ;Re-operation for SSI | — |
Countries
Benin, Rwanda
Contacts
Trials Management Team Leader