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

NCT05508152 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2023-09-22

No results posted yet for this study

Summary

Surgical site infection (SSI) is the main complication of surgery. The prevention of superficial SSI by topical prophylaxis is controversial. Human studies on wound lavage with topical solutions (saline, antiseptics or antibiotics) are old and do not yield conclusive results. In experimental conditions there is evidence in favor of the efficiency wound lavage with saline and antibiotic solutions. Clinical studies are needed to demonstrate the safety and efficacy of antibiotic lavage.

Objective. Study of the efficacy of topical antibiotic therapy in the prevention of SSI in patients undergoing incisional hernia repair after abdominal surgery.

Method. Randomized double-blind clinical trial comparing two groups of topical prophylaxis. Follow-up will be 90 days after operation. Data will be collected anonymously and the relationships between the variables will be analyzed using Pearson's chi-square, survival analysis and analysis of risk factors as appropriate. The effect of topical antibiotic on hospital stay, resistance patterns in SSI, and antibiotic serum levels will be analyzed.

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.

Sponsors & Collaborators

  • Hospital de Granollers

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2023-01-30
Completion
2023-06-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05508152 on ClinicalTrials.gov