Role of Wound Irrigation After Appendectomy

NCT ID: NCT03773224

Last Updated: 2020-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

179 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-20

Study Completion Date

2019-09-27

Brief Summary

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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.

Detailed Description

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Conditions

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Appendicitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Irrigation

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

Group Type ACTIVE_COMPARATOR

Irrigation

Intervention Type PROCEDURE

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

Control

The surgical wound is closed layer by layer without irrigation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Sameh Emile

Lecturer of general surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sameh H Emile

Role: STUDY_CHAIR

Mansoura University

Locations

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Mansoura university hospital

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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mansoura67

Identifier Type: -

Identifier Source: org_study_id

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