Impact of a new way of antibiotic enforcement applied in the patient's skin and wound used to reduce wound infections on elective abdominal wall surgery.
Phase 1
- Conditions
- Surgical site infection on incisional hernia remains still high (8-14%). Its apperance is related to long and costfull treatments (daily cures, antibiotics and hospital readmission) and it is also contributes to a higher one-year recurrence rate.Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2018-001860-45-ES
- Lead Sponsor
- Hospital Plató
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 228
Inclusion Criteria
Adults operated on elective incisional hernia surgery who would like to participate on the study and sign informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 114
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 114
Exclusion Criteria
Under-age patients (<18 years-old); no acceptance or removal for the patient; documented allergy to aminoglycosids.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To analise the use of topical Gentamicin on surgical site infection rate on elective incisional hernia surgery.;Secondary Objective: To analise the use of topical Gentamicin on one-year recurrence rate on elective incisional hernia surgery.;Primary end point(s): Incisional Surgical Site Infection (superficial and deep) rate after elective incisional hernia repair.;Timepoint(s) of evaluation of this end point: 7 and 30days; 6 and 12 months.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): One-year recurrence rate after elective incisional hernia repair.;Timepoint(s) of evaluation of this end point: 12 months