Evaluating the effectiveness of double-ring wound-edge protectors in preventing infections after 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
This study is testing whether using double-ring wound-edge protectors can help prevent infections in people who have had surgery for appendicitis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 671 (estimated) |
| Ages | 15 Years to 100 Years |
| Sex | All |
| Sponsor | Hospital Medina del Campo Academic / other |
| Locations | 1 site (Medina Del Campo) |
| Trial ID | NCT04860570 on ClinicalTrials.gov |
What this trial studies
This observational study assesses the effectiveness of double-ring wound-edge protectors in preventing superficial surgical site infections following open appendectomy for acute appendicitis. It is a multi-centric retrospective analysis comparing patients treated with either the double-ring protector or laparoscopic appendectomy between January 2011 and December 2016. The study aims to analyze the incidence of infections in both groups while ensuring compliance with data protection laws by collecting data anonymously.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 15 and older diagnosed with acute appendicitis who underwent open appendectomy with a double-ring wound-edge protector or laparoscopic appendectomy.
Not a fit: Patients who did not receive prophylactic antibiotics or have abdominal pathology unrelated to the caecal appendix may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved infection prevention strategies for patients undergoing open appendectomy.
How similar studies have performed: Previous studies have shown varying success with similar approaches, but this specific evaluation of double-ring wound-edge protectors is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Medina Del Campo
- Hospital Comarcal de Medina del Campo — Medina Del Campo, Spain (Recruiting)
Study contacts
- Principal investigator: Johnn Henry Herrera Kok — Complejo Asistencial Universitario de León, Spain
- Study coordinator: Johnn Henry Herrera Kok, MD
- Email: drjhherrerak@gmail.com
- Phone: +34 637729249
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.