A Randomized Controlled Trial on Wound Irrigation in Open Appendectomy.

Mansoura University

Status: Unknown

Conditions: Appendicitis

Treatments: Procedure: saline irrigation; Procedure: saline-gentamicin irrigation

Study type: Interventional

Funder types: Other

Identifiers

NCT04332809

mansoura333

Details and patient eligibility

About

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.

Enrollment: 208 estimated patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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208 participants in 3 patient groups

Saline-gentamicin irrigation

Active Comparator group

Description:

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

Treatment:

Procedure: saline-gentamicin irrigation

Saline irrigation

Active Comparator group

Description:

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

Treatment:

Procedure: saline irrigation

No irrigation

No Intervention group

Description:

ayer-by-layer irrigation of the appendectomy wound will not be performed