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

NCT04860570 | Unknown

• 1 other identifier: PI 21-2140 MEDINA
• Study Type: observational
• Target: 671
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Appendicitis; Surgical Site Infection

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Organ-space surgical site infection (oeSSI)

  30 days

• Hospital stay

  30 days

Study Arms (2)

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.

Device: Double-ring wound-edge protector

Laparoscopic Appendectomy (LA)

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

Interventions

Double-ring wound-edge protector DEVICE

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

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

Eligibility Criteria

• Age: 15 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients 15 years old or older, with diagnosis of acute appendicitis who were treated either by open appendectomy using a double-ring wound-edge protector or by laparoscopic appendectomy at Hospital Recoletas Campo Grande de Valladolid and Hospital Comarcal de Medina del Campo.

You may qualify if:

• 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.

You may not qualify if:

• Patients who did not receive prophylactic antibiotic.
• Source of abdominal pathology other than the caecal appendix.
• Follow-up period less than 30 days.

Sponsors & Collaborators

• Hospital Medina del Campo: lead

Study Sites (1)

Hospital Comarcal de Medina del Campo

Medina del Campo, 47400, Spain

RECRUITING

MeSH Terms

Conditions

Appendicitis; Surgical Wound Infection

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases; Wound Infection; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Johnn Henry Herrera Kok

  Complejo Asistencial Universitario de León, Spain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johnn Henry Herrera Kok, MD

CONTACT

+34 637729249; drjhherrerak@gmail.com

Juan Carlos Martín Del Olmo, MD, phD

CONTACT

+34 983838000; jcmolmo@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Johnn Henry Herrera Kok

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: April 27, 2021
• Study Start: October 25, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 7, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)