Prophylaxis of Surgical Wound Infection With Topical Antibiotics

NCT04476212 | Unknown DMC

• 1 other identifier: 20171013
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Surgical site infection; Prevention; Topical prophylaxis; Wound irrigation; Topical antibiotic prophylaxis; Abdominal surgery

Outcome Measures

Primary Outcomes (1)

• Surgical Site infection rate

  signs of infection at any level of surgical site

  30 days

Secondary Outcomes (1)

• Complications after surgery

  30 days

Study Arms (2)

Intervention

EXPERIMENTAL

In the experimental arm, the surgical wound will be irrigated using an antibiotic solution (amoxicillin-clavulanate) for topical prophylaxis

Other: Topical antibiotic prophylaxis

Control

NO INTERVENTION

In the control arm, the surgical wound will be irrigated with saline, which is our routine at present.

Interventions

Topical antibiotic prophylaxis OTHER

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients admitted for elective abdominal wall surgery by open route
• Patients admitted for urgent or elective cesarean section
• Patients undergoing elective surgery of the colon or rectum for neoplastic pathology (open or laparoscopy)
• Patients undergoing emergency abdominal surgery (open or laparoscopy)

You may not qualify if:

• Patients under treatment with immunosuppressors, corticosteroids and patients on hemodialysis
• Patients with primary peritonitis and liver cirrhosis
• Patients with suspected allergy to the antibiotic used in the study
• Patients who have recently undergone open abdomen surgery (up to 30 days pre-intervention) or to which the wound can not be closed surgical according to the surgeon's criteria
• Patients with American Society of Anaesthesiology classification 5.

Sponsors & Collaborators

• Hospital de Granollers: lead

Study Sites (1)

Fundació Privada Hospital Asil de Granollers

Granollers, Barcelona, 08402, Spain

RECRUITING

MeSH Terms

Conditions

Surgical Wound Infection; Infections; Hernia, Abdominal

Interventions

Antibiotic Prophylaxis

Condition Hierarchy (Ancestors)

Wound Infection; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hernia; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Chemoprevention; Drug Therapy; Therapeutics; Premedication

Study Officials

• Josep Maria Badia, PhD

  Fundació Privada Hospital Asil de Granollers

  PRINCIPAL INVESTIGATOR

• Felipe Ojeda, PhD

  Fundació Privada Hospital Asil de Granollers

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Josep Maria Badia, PhD

CONTACT

(+34) 938 425 000; jmbadia@fhag.es

Gemma Molist, PhD

CONTACT

(+34) 938 425 000; recerca@fjah.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: There will be masking for the patient, for the surgeon responsible for the case, for the investigator responsible for each study, for the coordinator of the center and for the main investigator. After the closure of the abdominal fascia, the patients will be randomized to one of the study groups. The circulating nurse will open the randomization envelope and prepare the solution indicated on the outside of the operating room. He/she will record the case on the database and will be the only person with knowledge of the group allocation of the case.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: It is a randomized, controlled, multicenter, blind study by observer and patient, with two parallel study groups, phase IV. The irrigation of the wound with 0.9% physiological serum will be compared with the irrigation with a solution of amoxicillin-clavulanate, administered topically and dissolved in saline.

Study Record Dates

• First Submitted: January 31, 2019
• First Posted: July 20, 2020
• Study Start: December 27, 2018
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 13, 2023

Record last verified: 2023-04

Locations

ES (1)