Role of Wound Irrigation After Appendectomy

Appendicitis Clinical Trial

Official title:

A Randomized Trial on Wound Irrigation in Prevention of Surgical Site Infection After Appendectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03773224
• Other study ID #: mansoura67
• Status: Completed
• Phase: N/A
• Start date: December 20, 2018
• Est. completion date: September 27, 2019

Study information

• Verified date: May 2020
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: September 27, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Appendicitis

Intervention

Procedure:
• Irrigation
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

Locations

Country	Name	City	State
Egypt	Mansoura university hospital	Mansourah	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical site infection	The incidence of superficial site infection as detected by clinical examination on follow-up	2 months after surgery