AppendicitisNCT04332809
A Randomized Controlled Trial on Wound Irrigation in Open Appendectomy.
A study testing saline-gentamicin irrigation and saline irrigation in people with Appendicitis, run by Mansoura University at 1 site in Egypt.
Trial summary
A large retrospective study compared wound irrigation with antiseptic solution, with antimicrobial agent, and with normal saline in patients undergoing open appendectomy and concluded an evident superiority of antibiotic wound irrigation over both normal saline and antiseptic solution. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Appendicitis
- What is being tested?
- saline-gentamicin irrigation and saline irrigation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 30 Apr 2020
- Phase
- Interventional
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The study included patients of both genders aging between 16 and 65 years who presented to the emergency department with acute appendicitis. Acute appendicitis was diagnosed by clinical examination and intraoperative findings and the diagnosis was confirmed with histopathologic examination of the removed appendix.
Who cannot join
- Patients with appendicular mass, appendicular abscess, appendicitis associated with generalized peritonitis, acute abdomen due to other causes as revealed intraoperatively, patients with normal appendix as revealed intraoperatively and after histopathologic examination, patients taking long course of steroid therapy or immunosuppressive treatment, and patients unwilling to participate in the trial.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura university hospital
Al Mansurah, Dakahlia Governorate, 35516
About this study
Official title: A Randomized Controlled Trial on Irrigation of Open Appendectomy Wound With Gentamicin- Saline Solution Versus Saline Solution for Prevention of Surgical Site Infection.
A large retrospective study compared wound irrigation with antiseptic solution, with antimicrobial agent, and with normal saline in patients undergoing open appendectomy and concluded an evident superiority of antibiotic wound irrigation over both normal saline and antiseptic solution.
The present trial aimed to assess the efficacy of layer-by-layer wound irrigation with gentamicin-saline solution versus saline solution in prevention of incisional SSI after open appendectomy for acute appendicitis. We postulated that irrigation of every layer of the surgical wound separately would help reduce the incidence of incisional SSI by eradication of bacterial contamination of each layer which may occur during delivery, manipulation, and removal of the inflamed appendix through the McBurney's incision.
- Conditions
- Appendicitis
- Being tested
- saline-gentamicin irrigation, saline irrigation
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
saline-gentamicin irrigationProcedure or surgery
Layer-by-layer irrigation of the appendectomy wound will be performed using saline-gentamicin solution
saline irrigationProcedure or surgery
Layer-by-layer irrigation of the appendectomy wound will be performed using saline solution
| Study group | Role | What they receive |
|---|---|---|
| Saline-gentamicin irrigation | Active comparator | layer-by-layer irrigation of the appendectomy wound will be performed using Saline-gentamicin solution Receives: Procedure: saline-gentamicin irrigation |
| Saline irrigation | Active comparator | layer-by-layer irrigation of the appendectomy wound will be performed using Saline solution Receives: Procedure: saline irrigation |
| No irrigation | No intervention | ayer-by-layer irrigation of the appendectomy wound will not be performed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of surgical site infection
SSI was defined according to the standard criteria devised by the center for disease and control (CDC). Purulent drainage from the wound, cellulitis requiring antibiotics, or the opening of a closed wound were considered criteria of Incisional SSI
Measured: 6 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start1 Jan 2019
- Primary completion31 Mar 2020
- Study completion30 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Emile, Mansoura University
- Investigators
- Sameh H Emile, M.D., Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04332809
- Sponsor's protocol ID
- mansoura333
- Status last verified
- Mar 2020
- First submitted
- 1 Apr 2020
- Last updated
- 3 Apr 2020
- Results posted
- No
- Data monitoring committee
- 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 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on Irrigation of Open Appendectomy Wound With Gentamicin- Saline Solution Versus Saline Solution for Prevention of Surgical Site Infection.
- ClinicalTrials.gov ID
- NCT04332809
- Acronym / sponsor ID
- mansoura333
- Conditions
- Appendicitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 30 Apr 2020 (estimated)
- First posted
- 3 Apr 2020 (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.
A large retrospective study compared wound irrigation with antiseptic solution, with antimicrobial agent, and with normal saline in patients undergoing open appendectomy and concluded an evident superiority of antibiotic wound irrigation over both normal saline and antiseptic solution.
The present trial aimed to assess the efficacy of layer-by-layer wound irrigation with gentamicin-saline solution versus saline solution in prevention of incisional SSI after open appendectomy for acute appendicitis. We postulated that irrigation of every layer of the surgical wound separately would help reduce the incidence of incisional SSI by eradication of bacterial contamination of each layer which may occur during delivery, manipulation, and removal of the inflamed appendix through the McBurney's incision.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Saline-gentamicin irrigation | Active comparator | Procedure: saline-gentamicin irrigationlayer-by-layer irrigation of the appendectomy wound will be performed using Saline-gentamicin solution |
| Saline irrigation | Active comparator | Procedure: saline irrigationlayer-by-layer irrigation of the appendectomy wound will be performed using Saline solution |
| No irrigation | No intervention | –ayer-by-layer irrigation of the appendectomy wound will not be performed |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- The study included patients of both genders aging between 16 and 65 years who presented to the emergency department with acute appendicitis. Acute appendicitis was diagnosed by clinical examination and intraoperative findings and the diagnosis was confirmed with histopathologic examination of the removed appendix.
Key exclusion criteria (1 listed)
- Patients with appendicular mass, appendicular abscess, appendicitis associated with generalized peritonitis, acute abdomen due to other causes as revealed intraoperatively, patients with normal appendix as revealed intraoperatively and after histopathologic examination, patients taking long course of steroid therapy or immunosuppressive treatment, and patients unwilling to participate in the trial.
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 |
|---|---|---|
| saline-gentamicin irrigationLayer-by-layer irrigation of the appendectomy wound will be performed using saline-gentamicin solution | Procedure or surgery | Saline-gentamicin irrigation |
| saline irrigationLayer-by-layer irrigation of the appendectomy wound will be performed using saline solution | Procedure or surgery | Saline irrigation |
Primary outcome
Incidence of surgical site infection
Time frame: 6 weeks after surgery
SSI was defined according to the standard criteria devised by the center for disease and control (CDC). Purulent drainage from the wound, cellulitis requiring antibiotics, or the opening of a closed wound were considered criteria of Incisional SSI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Individual participant dataSharing planned: No
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Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
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Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
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Piperacillin/Tazobactam Versus Ceftriaxone and Metronidazole for Children With Perforated Appendicitis
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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.
Sameh H Emile, M.D. principal investigator
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing saline-gentamicin irrigation and saline irrigation in people with Appendicitis, run by Mansoura University at 1 site in Egypt.
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 1 inclusion and 1 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 3 Apr 2020. 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 Egypt. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of surgical site infection (time frame: 6 weeks 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 3 Apr 2020.