An observational study in Acute Appendicitis and Surgical Site Infection, sponsored by Hospital Medina del Campo. Status unknown at 1 site in Spain. Open to participants aged 15 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-07.
Sponsored by Hospital Medina del Campo · Observational
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.
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.
417 studies on the registry are indexed under Appendicitis; 63 are open to participants now.
This study's planned enrollment of 671 is above the median of 207 across 153 observational studies indexed under Appendicitis.
Browse Appendicitis studies →Hospital Medina del Campo is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Control group: Patients with diagnosis of acute appendicitis treated by laparoscopic appendectomy.
Double-ring wound-edge protector: Alexis Applied Medical ®, Rancho Santa Margarita, California.
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.
Time frame: 30 days after surgery
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.
Time frame: 30 days
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.
Time frame: 30 days
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2024; primary completion for Dec 2024, 2 months later.
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This study is status unknown, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Hospital Medina del Campo