Prophylaxis of Surgical Wound Infection in Incisional Hernia Repair With Topical Antibiotics (PROTOP-PAR)

PHASE3CompletedINTERVENTIONAL
Enrollment

260

Participants

Timeline

Start Date

February 1, 2021

Primary Completion Date

January 30, 2023

Study Completion Date

June 30, 2023

Conditions
Postoperative Hernia
Interventions
DRUG

Wound irrigation with amoxicillin-clavulanate in saline solution

"Randomization will be made by means of the RedCap online program. At the arrival of the patient in the surgical area, the nursing team will be informed whether or not the patient has entered the protocol of the studio.~For each included case, the perioperative nurse will access RedCap and will proceed to include and randomize the case.~Once the patient's data has been introduced, the circulating nurse will enter the intervention group in a registration database, keeping it blinded to the surgical team.~In the experimental arm of the study, the circulating nurse will prepare a solution of amoxicillin-clavulanate acid (1000 mg of antibiotic in 500 mL of saline) outside the operating room. In case of open surgery, the thickness of the subcutaneous fat layer will be measured and recorded. After the closure of the aponeurosis, and before the closure of the skin, the wound will be irrigated with the antibiotic solution, and the soaked gauze placed on the wound for 3 minutes."

DRUG

Wound irrigation with a saline solution

"Randomization will be made by means of the RedCap online program. At the arrival of the patient in the surgical area, the nursing team will be informed whether or not the patient has entered the protocol of the studio. For each included case, the perioperative nurse will access RedCap and will proceed to include and randomize the case.~Once the patient's data has been introduced, the circulating nurse will enter the intervention group in a registration database, keeping it blinded to the surgical team.~If the case belongs to the sham group, at the end of the intervention, the circulating nurse will prepare a sham solution contaning only normal saline outside the operating room. In case of open surgery, the thickness of the subcutaneous fat layer will be measured and recorded. After the closure of the aponeurosis, and before the closure of the skin, the wound will be irrigated with saline, and the soaked gauze placed on the wound for 3 minutes."

Trial Locations (1)

08402

Hospital General de Granollers, Granollers

All Listed Sponsors
lead

Hospital de Granollers

OTHER

NCT05508152 - Prophylaxis of Surgical Wound Infection in Incisional Hernia Repair With Topical Antibiotics (PROTOP-PAR) | Biotech Hunter | Biotech Hunter