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

Surgical Site Infection Clinical Trial

— sSSI-2RWEPs  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04860570
• Other study ID #: PI 21-2140 MEDINA
• Status: Recruiting
• Start date: October 25, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: Hospital Medina del Campo
• Contact: Johnn Henry Herrera Kok, MD
• Phone: +34 637729249
• Email: drjhherrerak[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 671
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Appendicitis
• Appendicitis
• Communicable Diseases
• Infections
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Device:
• Double-ring wound-edge protector
Double-ring wound-edge protector: Alexis Applied Medical ®, Rancho Santa Margarita, California.

Locations

Country	Name	City	State
Spain	Hospital Comarcal de Medina del Campo	Medina Del Campo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Medina del Campo

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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