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

Recruiting

• Conditions: Acute Appendicitis; Surgical Site Infection
• Interventions: Device: Double-ring wound-edge protector

• Registration Number: NCT04860570
• Lead Sponsor: Hospital 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.

Study Timeline

• Study First Submitted: 2021-04-22
• Study First Submitted QC: 2021-04-22
• Study First Posted: 2021-04-27
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-06
• Last Update Posted: 2023-12-07
• Study Start: 2024-10-25
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 671

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Open Appendectomy (OA) + Double-ring wound-edge protector (2RWEP)	Double-ring wound-edge protector	Intervention group: Patients with diagnosis of acute appendicitis treated by open appendectomy using a double-ring wound-edge protector.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hospital Comarcal de Medina del Campo; 🇪🇸 Medina Del Campo, Spain