Acute Appendicitis, Surgical Site Infection
Conditions
Keywords
Acute appendicitis, double-ring wound-edge protector, superficial surgical site infection
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.
Interventions
DEVICEDouble-ring wound-edge protector
Double-ring wound-edge protector: Alexis Applied Medical ®, Rancho Santa Margarita, California.
Sponsors
Hospital Medina del Campo
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to 100 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Superficial surgical site infection (sSSI) | 30 days after surgery | To compare the incidence of sSSI in both groups (OA+2RWEP versus LA) during postoperative period to determine wether 2RWEP are useful in reducing sSSI after open appendectomy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Organ-space surgical site infection (oeSSI) | 30 days | To compare the incidence of oeSSI in both groups (OA+2RWEP versus LA) during postoperative period to determine wether 2RWEP are useful in reducing oeSSI after open appendectomy. |
| Hospital stay | 30 days | To compare the length of hospital stay in both groups (OA+2RWEP versus LA) to determine wether 2RWEP are useful in reducing hospital stay. |
Countries
Spain
Contacts
Primary ContactJohnn Henry Herrera Kok, MD
Backup ContactJuan Carlos Martín Del Olmo, MD, phD
Outcome results
None listed