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Clinical Trials/NCT03773224
NCT03773224CompletedNot Applicable

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

Mansoura University1 site in 1 country179 target enrollmentStarted: December 20, 2018Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
179
Locations
1
Primary Endpoint
Surgical site infection
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
16 Years to 65 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Irrigation

Active Comparator

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

Intervention: Irrigation (Procedure)

Control

No Intervention

The surgical wound is closed layer by layer without irrigation

Outcomes

Primary Outcomes

Surgical site infection

Time Frame: 2 months after surgery

The incidence of superficial site infection as detected by clinical examination on follow-up

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sameh Emile

Lecturer of general surgery

Mansoura University

Study Sites (1)

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