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A Randomized Controlled Trial on Wound Irrigation in Open Appendectomy.

A Randomized Controlled Trial on Irrigation of Open Appendectomy Wound With Gentamicin- Saline Solution Versus Saline Solution for Prevention of Surgical Site Infection.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04332809
Enrollment
208
Registered
2020-04-03
Start date
2019-01-01
Completion date
2020-04-30
Last updated
2020-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Appendicitis

Brief summary

A large retrospective study compared wound irrigation with antiseptic solution, with antimicrobial agent, and with normal saline in patients undergoing open appendectomy and concluded an evident superiority of antibiotic wound irrigation over both normal saline and antiseptic solution. The present trial aimed to assess the efficacy of layer-by-layer wound irrigation with gentamicin-saline solution versus saline solution in prevention of incisional SSI after open appendectomy for acute appendicitis. We postulated that irrigation of every layer of the surgical wound separately would help reduce the incidence of incisional SSI by eradication of bacterial contamination of each layer which may occur during delivery, manipulation, and removal of the inflamed appendix through the McBurney's incision.

Interventions

PROCEDUREsaline-gentamicin irrigation

Layer-by-layer irrigation of the appendectomy wound will be performed using saline-gentamicin solution

Layer-by-layer irrigation of the appendectomy wound will be performed using saline solution

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* The study included patients of both genders aging between 16 and 65 years who presented to the emergency department with acute appendicitis. Acute appendicitis was diagnosed by clinical examination and intraoperative findings and the diagnosis was confirmed with histopathologic examination of the removed appendix.

Exclusion criteria

* Patients with appendicular mass, appendicular abscess, appendicitis associated with generalized peritonitis, acute abdomen due to other causes as revealed intraoperatively, patients with normal appendix as revealed intraoperatively and after histopathologic examination, patients taking long course of steroid therapy or immunosuppressive treatment, and patients unwilling to participate in the trial.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of surgical site infection6 weeks after surgerySSI was defined according to the standard criteria devised by the center for disease and control (CDC). Purulent drainage from the wound, cellulitis requiring antibiotics, or the opening of a closed wound were considered criteria of Incisional SSI

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026