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Role of Wound Irrigation After Appendectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03773224
Recruitment Status : Completed
First Posted : December 12, 2018
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
Sameh Emile, Mansoura University

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : December 20, 2018
Actual Primary Completion Date : August 1, 2019
Actual Study Completion Date : September 27, 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Surgical site infection [ Time Frame: 2 months after surgery ]
    The incidence of superficial site infection as detected by clinical examination on follow-up



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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03773224


Locations
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Egypt
Mansoura university hospital
Mansourah, Dakahlia, Egypt
Sponsors and Collaborators
Mansoura University
Investigators
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Study Chair: Sameh H Emile Mansoura University
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Responsible Party: Sameh Emile, Lecturer of general surgery, Mansoura University
ClinicalTrials.gov Identifier: NCT03773224    
Other Study ID Numbers: mansoura67
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases