Are Double-ring Wound-edge Protectors Effective for Preventing Superficial Surgical Site Infection After Open Appendectomy? (sSSI-2RWEPs)

Hospital Medina del Campo

Status: Enrolling

Conditions: Surgical Site Infection; Acute Appendicitis

Treatments: Device: Double-ring wound-edge protector

Study type: Observational

Funder types: Other

Identifiers

NCT04860570

PI 21-2140 MEDINA

Details and patient eligibility

About

This study aims to evaluate the utility of double-ring wound-edge protectors to prevent the development of superficial surgical site infections after open appendectomy.

Full description

This is a multi-centric retrospective study comparing patients of similar characteristics with diagnosis of acute appendicitis that have been treated either by open appendectomy using a double-ring wound-edge protector or by laparoscopic appendectomy between January 2011 and December 2016 at Hospital Recoletas Campo Grande de Valladolid and Hospital Comarcal de Medina del Campo.

The main objective of the study is to compare the incidence of superficial surgical site infection in both groups.

All patients included in the study must meet inclusion criteria and all data will be collected anonymously in order to comply with local law on personal data protection (Organic Law 15/1999 from 13 December about personal data protection).

The authors of the study expect results of the study to be comparable with those in current literature regarding surgical site infections, hospital stay and procedure safety.

Enrollment: 671 estimated patients

Sex: All

Ages: 15 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age of at least 15 years old.
• Clinical diagnosis of acute appendicitis.
• Treated by: Open appendectomy + double-ring wound-edge protector or Laparoscopic appendectomy.
• Note: with the aim of avoiding selection bias, all patients presenting risk factors for surgical site infections (eg obesity, diabetes, malnourishment, immunosupression, etc.) will be included in the present study.

Exclusion criteria

• Patients who did not receive prophylactic antibiotic.
• Source of abdominal pathology other than the caecal appendix.
• Follow-up period less than 30 days.

Trial design

671 participants in 2 patient groups

Open Appendectomy (OA) + Double-ring wound-edge protector (2RWEP)

Description:

Intervention group: Patients with diagnosis of acute appendicitis treated by open appendectomy using a double-ring wound-edge protector.

Treatment:

Device: Double-ring wound-edge protector

Laparoscopic Appendectomy (LA)

Description:

Control group: Patients with diagnosis of acute appendicitis treated by laparoscopic appendectomy.