Role of Wound Irrigation After Appendectomy
A Randomized Trial on Wound Irrigation in Prevention of Surgical Site Infection After Appendectomy
1 other identifier
interventional
179
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2018
CompletedFirst Posted
Study publicly available on registry
December 12, 2018
CompletedStudy Start
First participant enrolled
December 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 27, 2019
CompletedMay 27, 2020
May 1, 2020
7 months
December 10, 2018
May 24, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Surgical site infection
The incidence of superficial site infection as detected by clinical examination on follow-up
2 months after surgery
Study Arms (2)
Irrigation
ACTIVE COMPARATORLayer by layer irrigation of the surgical wound with gentamicin-saline solution
Control
NO INTERVENTIONThe surgical wound is closed layer by layer without irrigation
Interventions
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
Eligibility Criteria
You may qualify if:
- Adult patients of both genders aging between 18 and 65 years who present with acute appendicitis.
- Patients with perforated appendicitis will be also included.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mansoura university hospital
Al Mansurah, Dakahlia Governorate, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Sameh H Emile
Mansoura University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of general surgery
Study Record Dates
First Submitted
December 10, 2018
First Posted
December 12, 2018
Study Start
December 20, 2018
Primary Completion
August 1, 2019
Study Completion
September 27, 2019
Last Updated
May 27, 2020
Record last verified: 2020-05