A Randomized Controlled Trial on Wound Irrigation in Open Appendectomy.

Study Overview
=================
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.

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.

Conditions
-----------------
Appendicitis

Intervention / Treatment
-----------------
* Procedure: saline-gentamicin irrigation
* Procedure: saline irrigation


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Saline-gentamicin irrigation<br>layer-by-layer irrigation of the appendectomy wound will be performed using Saline-gentamicin solution | Procedure: saline-gentamicin irrigation<br>* Layer-by-layer irrigation of the appendectomy wound will be performed using saline-gentamicin solution<br>|
| Active Comparator: Saline irrigation<br>layer-by-layer irrigation of the appendectomy wound will be performed using Saline solution | Procedure: saline irrigation<br>* Layer-by-layer irrigation of the appendectomy wound will be performed using saline solution<br>|
| No Intervention: No irrigation<br>ayer-by-layer irrigation of the appendectomy wound will not be performed | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 weeks after surgery |