Back to resultsRole of Wound Irrigation After Appendectomy
Primary Purpose
Appendicitis
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Irrigation
Sponsored by
About this trial
This is an interventional treatment trial for Appendicitis
Eligibility Criteria
Inclusion Criteria:
- Adult patients of both genders aging between 18 and 65 years who present with acute appendicitis.
- Patients with perforated appendicitis will be also included.
Exclusion Criteria:
- Patients with appendicular mass, appendicular abscess, generalized peritonitis.
- Patients with other causes of acute abdomen as revealed intraoperatively.
- Patients taking long course of steroid therapy or immunosuppressive treatment,
- Patients unwilling to participate in the trial.
Sites / Locations
- Mansoura university hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Irrigation
Control
Arm Description
Layer by layer irrigation of the surgical wound with gentamicin-saline solution
The surgical wound is closed layer by layer without irrigation
Outcomes
Primary Outcome Measures
Surgical site infection
The incidence of superficial site infection as detected by clinical examination on follow-up
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03773224
Brief Title
Role of Wound Irrigation After Appendectomy
Official Title
A Randomized Trial on Wound Irrigation in Prevention of Surgical Site Infection After Appendectomy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
December 20, 2018 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
September 27, 2019 (Actual)
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
Surgical site infection is a common problem after open appendectomy. Irrigation of the surgical wound by topical antibiotics has been devised as a measure to reduce the incidence of wound infection. The present trial aims to assess the efficacy of layer-by-layer wound irrigation with gentamicin-saline solution in prevention of superficial surgical site infection after open appendectomy for acute uncomplicated appendicitis.
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
179 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Irrigation
Arm Type
Active Comparator
Arm Description
Layer by layer irrigation of the surgical wound with gentamicin-saline solution
Arm Title
Control
Arm Type
No Intervention
Arm Description
The surgical wound is closed layer by layer without irrigation
Intervention Type
Procedure
Intervention Name(s)
Irrigation
Intervention Description
upon closure of the peritoneum gentamicin-saline solution (160 mg of gentamicin in 400 ml of normal saline 0.9%) will be used for irrigation of every layer of the wound before its closure
Primary Outcome Measure Information:
Title
Surgical site infection
Description
The incidence of superficial site infection as detected by clinical examination on follow-up
Time Frame
2 months 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:
Adult patients of both genders aging between 18 and 65 years who present with acute appendicitis.
Patients with perforated appendicitis will be also included.
Exclusion Criteria:
Patients with appendicular mass, appendicular abscess, generalized peritonitis.
Patients with other causes of acute abdomen as revealed intraoperatively.
Patients taking long course of steroid therapy or immunosuppressive treatment,
Patients unwilling to participate in the trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameh H Emile
Organizational Affiliation
Mansoura University
Official's Role
Study Chair
Facility Information:
Facility Name
Mansoura university hospital
City
Mansourah
State/Province
Dakahlia
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Role of Wound Irrigation After Appendectomy
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