Are Double-ring Wound-edge Protectors Effective for Preventing Superficial Surgical Site Infection After Open Appendectomy?

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Acute Appendicitis, Surgical Site Infection

Intervention / Treatment
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* Device: Double-ring wound-edge protector


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Open Appendectomy (OA) + Double-ring wound-edge protector (2RWEP)<br>Intervention group: Patients with diagnosis of acute appendicitis treated by open appendectomy using a double-ring wound-edge protector. | Device: Double-ring wound-edge protector<br>* Double-ring wound-edge protector: Alexis Applied Medical ®, Rancho Santa Margarita, California.<br>|
| Laparoscopic Appendectomy (LA)<br>Control group: Patients with diagnosis of acute appendicitis treated by laparoscopic appendectomy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Superficial surgical site infection (sSSI) | 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. | 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Organ-space surgical site infection (oeSSI) | 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. | 30 days | 
| Hospital stay | To compare the length of hospital stay in both groups (OA+2RWEP versus LA) to determine wether 2RWEP are useful in reducing hospital stay. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute appendicitis, double-ring wound-edge protector, superficial surgical site infection