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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| Laparoscopic Appendectomy (LA) | Control group: Patients with diagnosis of acute appendicitis treated by laparoscopic appendectomy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Double-ring wound-edge protector | Device | Double-ring wound-edge protector: Alexis Applied Medical ®, Rancho Santa Margarita, California. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Hospital stay |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Johnn Henry Herrera Kok, MD | Contact | +34 637729249 | drjhherrerak@gmail.com | |
| Juan Carlos Martín Del Olmo, MD, phD | Contact | +34 983838000 | jcmolmo@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Johnn Henry Herrera Kok | Complejo Asistencial Universitario de León, Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Comarcal de Medina del Campo | Recruiting | Medina del Campo | 47400 | Spain |
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| ID | Term |
|---|---|
| D001064 | Appendicitis |
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
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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 |
| D004066 |
| Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
| D014946 | Wound Infection |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |