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Prophylaxis of Surgical Wound Infection With Topical Antibiotics

NCT04476212 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 560

Last updated 2023-04-13

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 abdominal surgery with different risk of infection. Method. Project comprising several randomized double-blind clinical trials with a common methodology. Procedures with varying degrees of contamination, as emergency abdominal surgery, cesareans and complex abdominal wall reconstructions will be studied. Follow-up will be 30 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

  • Surgical Site Infection
  • Surgery--Complications
  • Colorectal Surgery
  • Cesarean Section; Infection
  • Hernia, Abdominal

Interventions

OTHER

Topical antibiotic prophylaxis

The surgical wound will be irrigated with an antibiotic solution, and then we will apply the same solution using gauze for two minutes on the wound

Sponsors & Collaborators

  • Hospital de Granollers

    lead OTHER

Principal Investigators

  • Josep Maria Badia, PhD · Fundació Privada Hospital Asil de Granollers

  • Felipe Ojeda, PhD · Fundació Privada Hospital Asil de Granollers

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-27
Primary Completion
2023-12-31
Completion
2023-12-31

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 NCT04476212 on ClinicalTrials.gov