NCT04860570

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 671 (estimated)
• Sponsor: Hospital Medina del Campo · Academic / Other
• Sex: All
• Age: 15 Years – 100 Years
• Healthy volunteers: Accepted

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.

Conditions

• Acute Appendicitis
• Surgical Site Infection

Interventions

Type	Name	Description
DEVICE	Double-ring wound-edge protector	Double-ring wound-edge protector: Alexis Applied Medical ®, Rancho Santa Margarita, California.

Timeline

• Start date: 2024-10-25
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2021-04-27
• Last updated: 2023-12-07

Locations

1 site across 1 country: Spain