Back to resultsA Randomized Controlled Trial on Wound Irrigation in Open Appendectomy.
Primary Purpose
Appendicitis
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
saline-gentamicin irrigation
saline irrigation
Sponsored by
About this trial
This is an interventional treatment trial for Appendicitis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Mansoura university hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
Saline-gentamicin irrigation
Saline irrigation
No irrigation
Arm Description
layer-by-layer irrigation of the appendectomy wound will be performed using Saline-gentamicin solution
layer-by-layer irrigation of the appendectomy wound will be performed using Saline solution
ayer-by-layer irrigation of the appendectomy wound will not be performed
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04332809
Brief Title
A Randomized Controlled Trial on Wound Irrigation in Open Appendectomy.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
April 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
208 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Saline-gentamicin irrigation
Arm Type
Active Comparator
Arm Description
layer-by-layer irrigation of the appendectomy wound will be performed using Saline-gentamicin solution
Arm Title
Saline irrigation
Arm Type
Active Comparator
Arm Description
layer-by-layer irrigation of the appendectomy wound will be performed using Saline solution
Arm Title
No irrigation
Arm Type
No Intervention
Arm Description
ayer-by-layer irrigation of the appendectomy wound will not be performed
Intervention Type
Procedure
Intervention Name(s)
saline-gentamicin irrigation
Intervention Description
Layer-by-layer irrigation of the appendectomy wound will be performed using saline-gentamicin solution
Intervention Type
Procedure
Intervention Name(s)
saline irrigation
Intervention Description
Layer-by-layer irrigation of the appendectomy wound will be performed using saline solution
Primary Outcome Measure Information:
Title
Incidence of surgical site infection
Description
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
Time Frame
6 weeks after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameh H Emile, M.D.
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura university hospital
City
Mansourah
State/Province
Dakahlia
ZIP/Postal Code
35516
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Randomized Controlled Trial on Wound Irrigation in Open Appendectomy.
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