Prophylaxis of Surgical Wound Infection With Topical Antibiotics

NCT ID: NCT04476212

Last Updated: 2023-04-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 560 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-27
• Study Completion Date: 2023-12-31

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.

Detailed Description

Several Surgical site infection (SSI) prevention guidelines have been published over the last 10 years. Topical prophylaxis of the surgical wound with antibiotics or antiseptics is one of the most controversial measures proposed for SSI prevention. Two guidelines (British, Spanish Ministry of Health) explicitly recommend not irrigating surgical wounds with any product. The World Health Organization considers irrigation with antibiotics as an unresolved issue and, together with the Centers for Disease Control, recommends irrigation with a solution of povidone iodine. The other four guides do not mention the measure. In Catalonia, a SSI prevention bundle recommends wound irrigation with saline, with a low level of recommendation.

Therefore, topical prophylaxis with operational wound washings with different solutions has been poorly studied, evokes contradictory recommendations and is not included in the majority of clinical practice guidelines for SSI prevention.

However, there we detected a high level of use of wound irrigation at the end of an intervention in actual clinical practice. In a survey conducted by 2017 by our group and answered by 845 general surgeons of the Spanish Association of Surgeons, before closing the skin, most surgeons (80.6%) irrigate the subcutaneous layer of the wound, either with saline (51.2%), an antiseptic solution (23.8%) or an antibiotic solution (1.5%). Only 19.4% of respondents do not irrigate. In another survey in 2018, focused on colorectal surgeons of two Spanish associations, similar rates of irrigation with saline, antiseptic or antibiotic were used (55%, 28.9% and 2.2%, respectively) The hypothesis of the study is that topical prophylaxis of the surgical wound with irrigation with an antibiotic solution decreases the rate of postoperative infection in patients undergoing abdominal surgery with different levels of contamination.

The study will compare the efficacy of topical prophylaxis in the surgical wound with an irrigation with an antibiotic solution in the incidence of SSI in abdominal surgery.

It is a randomized, controlled, multicenter, blind study by observer and patient, with two parallel study groups, phase IV.

Design of studies The project includes several prospective comparative studies on the effect of irrigation of surgical wounds with an antibiotic solution on the incisional SSI rate in abdominal surgery. The studies share a unique methodology applied to various types of abdominal surgery with different expected SSI rates and different risk factors.

In the trials, the irrigation of the wound with 0.9% physiological serum will be compared with the irrigation with an active principle solution of a pharmaceutical specialty of proven efficacy by parenteral route, administered topically and dissolved in physiological serum.

Four studies on different types of operations are defined according to the risk of infection:

• Study 1. Complex abdominal wall surgery
• Study 2. Cesarean section
• Study 3. Colorectal elective surgery
• Study 4. Emergency abdominal surgery For each study two groups will be formed, the study group (irrigation with antibiotic solution) and the control group (irrigation with saline).

The project has received the Spanish Drug Agency authorization as a low intervention study, a grant from the Spanish Ministry of Health and the Ethics Committee authorization of the Hospital General of Granollers.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Intervention

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

Group Type: EXPERIMENTAL

Topical antibiotic prophylaxis

Intervention Type: 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

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Granollers

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Josep Maria Badia, PhD

Role: PRINCIPAL_INVESTIGATOR

Fundació Privada Hospital Asil de Granollers

Felipe Ojeda, PhD

Role: PRINCIPAL_INVESTIGATOR

Fundació Privada Hospital Asil de Granollers

Locations

Fundació Privada Hospital Asil de Granollers

Granollers, Barcelona, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Josep Maria Badia, PhD

Role: CONTACT

jmbadia@fhag.es

(+34) 938 425 000 ext. 2571

Gemma Molist, PhD

Role: CONTACT

recerca@fjah.es

(+34) 938 425 000 ext. 2973

Facility Contacts

Josep Maria Badia, PhD

Role: primary

jmbadia@fhag.es

(+34) 938 425 000 ext. 2571

Gemma Molist, PhD

Role: backup

recerca@fhag.es

(+34) 938 425 000 ext. 2973

Other Identifiers

20171013

Identifier Type: -

Identifier Source: org_study_id