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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

Tracking Information
First Submitted Date  ICMJE December 10, 2018
First Posted Date  ICMJE December 12, 2018
Last Update Posted Date May 27, 2020
Actual Study Start Date  ICMJE December 20, 2018
Actual Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2018)
Surgical site infection [ Time Frame: 2 months after surgery ]
The incidence of superficial site infection as detected by clinical examination on follow-up
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Role of Wound Irrigation After Appendectomy
Official Title  ICMJE A Randomized Trial on Wound Irrigation in Prevention of Surgical Site Infection After Appendectomy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Appendicitis
Intervention  ICMJE 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
Study Arms  ICMJE
  • Active Comparator: Irrigation
    Layer by layer irrigation of the surgical wound with gentamicin-saline solution
    Intervention: Procedure: Irrigation
  • No Intervention: Control
    The surgical wound is closed layer by layer without irrigation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 27, 2019)
179
Original Estimated Enrollment  ICMJE
 (submitted: December 10, 2018)
116
Actual Study Completion Date  ICMJE September 27, 2019
Actual Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03773224
Other Study ID Numbers  ICMJE mansoura67
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Sameh Emile, Mansoura University
Study Sponsor  ICMJE Mansoura University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Sameh H Emile Mansoura University
PRS Account Mansoura University
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP