Role of Wound Irrigation After Appendectomy

Sponsor

Mansoura University (Other)

Overall Status

Completed

CT.gov ID

NCT03773224

Collaborator

(none)

179

Enrollment

Location

Arms

9.2

Actual Duration (Months)

19.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Appendicitis	Procedure: Irrigation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

179 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 20, 2018

Actual Primary Completion Date :

Aug 1, 2019

Actual Study Completion Date :

Sep 27, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Irrigation Layer by layer irrigation of the surgical wound with gentamicin-saline solution	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
No Intervention: Control The surgical wound is closed layer by layer without irrigation

Arm

Intervention/Treatment

Active Comparator: Irrigation

Layer by layer irrigation of the surgical wound with gentamicin-saline solution

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

No Intervention: Control

The surgical wound is closed layer by layer without irrigation

Outcome Measures

Primary Outcome Measures

Surgical site infection [2 months after surgery]
The incidence of superficial site infection as detected by clinical examination on follow-up

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mansoura university hospital	Mansourah	Dakahlia	Egypt

Sponsors and Collaborators

Mansoura University

Investigators

Study Chair: Sameh H Emile, Mansoura University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sameh Emile, Lecturer of general surgery, Mansoura University

ClinicalTrials.gov Identifier:

NCT03773224

Other Study ID Numbers:

mansoura67

First Posted:

Dec 12, 2018

Last Update Posted:

May 27, 2020

Last Verified:

May 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Appendicitis

Study Results

No Results Posted as of May 27, 2020