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.

Impact of topical antibiotic prophylaxis with Gentamicin on SSI rate on elective incisional hernia surgery: a randomised clinical trial. - Topical antibiotic on elective incisional hernia surgery.

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001860-45-ES

Enrollment

228

Registered

2019-07-04

Start date

2020-01-14

Completion date

Unknown

Last updated

2020-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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.

Interventions

Trade Name: Gentamicin BRAUN 1mg/mL 80 mL Product Name: Gentamicin Product Code: J01GB Pharmaceutical Form: Emulsion for injection/infusion

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: Under-age patients (<18 years-old); no acceptance or removal for the patient; documented allergy to aminoglycosids.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
Secondary end point(s): One-year recurrence rate after elective incisional hernia repair.;Timepoint(s) of evaluation of this end point: 12 months	—

Countries

Spain

Contacts

Public ContactMontserrat Juvany

Hospital Plató

mjuvanygomez@gmail.com0034659007969

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 5, 2026