Acute AppendicitissSSI-2RWEPsNCT04860570
Are Double-ring Wound-edge Protectors Effective for Preventing Superficial Surgical Site Infection After Open Appendectomy?
An observational study of Acute Appendicitis and Surgical Site Infection, run by Hospital Medina del Campo at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Appendicitis, Surgical Site Infection
- What is being tested?
- Double-ring wound-edge protector
- Type of treatment
- Medical device
- How many people
- 671 participants
- Where
- 1 siteSpain
- Study dates
- 25 Oct 2024to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients who did not receive prophylactic antibiotic.
- Source of abdominal pathology other than the caecal appendix.
- Follow-up period less than 30 days.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Comarcal de Medina del Campo
Medina del Campo, 47400
Johnn Henry Herrera Kok, MD, drjhherrerak@gmail.com
Juan Carlos Martín Del Olmo, MD, phD, jcmolmo@gmail.com
About this study
Official title: 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 aims to evaluate the utility of double-ring wound-edge protectors to prevent the development of superficial surgical site infections after open appendectomy.
Read the detailed description
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
- Acute Appendicitis, Surgical Site Infection
- Being tested
- Double-ring wound-edge protector
- Keywords
- Acute appendicitis, double-ring wound-edge protector, superficial surgical site infection
- Medical subject headings
- Appendicitis, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double-ring wound-edge protectorDevice
Double-ring wound-edge protector: Alexis Applied Medical ®, Rancho Santa Margarita, California.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Double-ring wound-edge protector | |
| Laparoscopic Appendectomy (LA) | Control group: Patients with diagnosis of acute appendicitis treated by laparoscopic appendectomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days after surgery
Secondary outcomes (2)
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.
Measured: 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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start25 Oct 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 671 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Medina del Campo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johnn Henry Herrera Kok, Hospital Medina del Campo
- Investigators
- Johnn Henry Herrera Kok, Principal investigator, Complejo Asistencial Universitario de León, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04860570
- Sponsor's protocol ID
- PI 21-2140 MEDINA
- Acronym
- sSSI-2RWEPs
- Status last verified
- Dec 2023
- First submitted
- 22 Apr 2021
- Last updated
- 7 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04860570
- Acronym / sponsor ID
- sSSI-2RWEPs / PI 21-2140 MEDINA
- Conditions
- Acute Appendicitis, Surgical Site Infection
- Keywords
- Acute appendicitis, double-ring wound-edge protector, superficial surgical site infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 671 participants (estimated)
- Lead sponsor
- Hospital Medina del CampoUniversity, hospital or other
- Study start
- 25 Oct 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open Appendectomy (OA) + Double-ring wound-edge protector (2RWEP) | – | Device: Double-ring wound-edge protectorIntervention 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. |
Who may qualify
- Ages
- 15 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients who did not receive prophylactic antibiotic.
- Source of abdominal pathology other than the caecal appendix.
- Follow-up period less than 30 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Double-ring wound-edge protectorDouble-ring wound-edge protector: Alexis Applied Medical ®, Rancho Santa Margarita, California. | Device | Open Appendectomy (OA) + Double-ring wound-edge protector (2RWEP) |
Primary outcome
Superficial surgical site infection (sSSI)
Time frame: 30 days after surgery
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.
2 secondary outcomes
Organ-space surgical site infection (oeSSI)
Time frame: 30 days
Hospital stay
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnn Henry Herrera Kok principal investigator
Complejo Asistencial Universitario de León, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Appendicitis and Surgical Site Infection, run by Hospital Medina del Campo at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johnn Henry Herrera Kok, MD (+34 637729249, drjhherrerak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Superficial surgical site infection (sSSI) (time frame: 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.