Clinical trial NCT04860570: Are Double-ring Wound-edge Protectors Effective for Preventing Superficial Surgical Site Infection After Open Appendectomy?
Official title: Retrospective, Multi-centric Study Comparing the Incidence of Surgical Site Infections in Patients Receiving Open Appendectomy With Double-ring Wound-edge Protectors Versus Laparoscopic Appendectomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Appendicitis
Surgical Site Infection
Keywords: Acute appendicitis
double-ring wound-edge protector
superficial surgical site infection
Lead sponsor: Hospital Medina del Campo
Sponsor class: OTHER
First posted: 2021-04-27
Enrollment: 671
Sex: ALL
Minimum age (years): 15
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients 15 years old or older, with diagnosis of acute appendicitis who were treated either by open appendectomy using a double-ring wound-edge protector or by laparoscopic appendectomy at Hospital Recoletas Campo Grande de Valladolid and Hospital Comarcal de Medina del Campo.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Superficial surgical site infection (sSSI)
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Organ-space surgical site infection (oeSSI)
timeFrame: 30 days
measure: Hospital stay
timeFrame: 30 days
Other outcomes:
Locations:
city: Medina Del Campo
country: Spain
facility: Hospital Comarcal de Medina del Campo
Study officials:
affiliation: Complejo Asistencial Universitario de León, Spain
name: Johnn Henry Herrera Kok
role: PRINCIPAL_INVESTIGATOR
References: