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

NCT ID: NCT04860570

Last Updated: 2023-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

671 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-25

Study Completion Date

2024-12-31

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.

Conditions

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Acute Appendicitis Surgical Site Infection

Keywords

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Acute appendicitis double-ring wound-edge protector superficial surgical site infection

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Open Appendectomy (OA) + Double-ring wound-edge protector (2RWEP)

Intervention group: Patients with diagnosis of acute appendicitis treated by open appendectomy using a double-ring wound-edge protector.

Double-ring wound-edge protector

Intervention Type DEVICE

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

Laparoscopic Appendectomy (LA)

Control group: Patients with diagnosis of acute appendicitis treated by laparoscopic appendectomy.

No interventions assigned to this group

Interventions

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Double-ring wound-edge protector

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

Intervention Type DEVICE

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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Medina del Campo

OTHER

Sponsor Role lead

Responsible Party

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Johnn Henry Herrera Kok

Dr. Johnn Henry Herrera Kok

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Johnn Henry Herrera Kok

Role: PRINCIPAL_INVESTIGATOR

Complejo Asistencial Universitario de León, Spain

Locations

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Hospital Comarcal de Medina del Campo

Medina del Campo, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Johnn Henry Herrera Kok, MD

Role: CONTACT

Phone: +34 637729249

Email: [email protected]

Juan Carlos Martín Del Olmo, MD, phD

Role: CONTACT

Phone: +34 983838000

Email: [email protected]

Facility Contacts

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Johnn Henry Herrera Kok, MD

Role: primary

Juan Carlos Martín Del Olmo, MD, phD

Role: backup

Other Identifiers

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PI 21-2140 MEDINA

Identifier Type: -

Identifier Source: org_study_id