A Randomized Controlled Trial on Wound Irrigation in Open Appendectomy.

NCT04332809 | Unknown

• 1 other identifier: mansoura333
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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.

Conditions

Appendicitis

Outcome Measures

Primary Outcomes (1)

• Incidence of surgical site infection

  SSI 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

  6 weeks after surgery

Study Arms (3)

Saline-gentamicin irrigation

ACTIVE COMPARATOR

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

Procedure: saline-gentamicin irrigation

Saline irrigation

ACTIVE COMPARATOR

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

Procedure: saline irrigation

No irrigation

NO INTERVENTION

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

Interventions

saline-gentamicin irrigation PROCEDURE

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

Saline-gentamicin irrigation

saline irrigation PROCEDURE

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

Saline irrigation

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura university hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Study Officials

• Sameh H Emile, M.D.

  Mansoura University

  PRINCIPAL INVESTIGATOR

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: Associate professor of surgery

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 3, 2020
• Study Start: January 1, 2019
• Primary Completion: March 31, 2020
• Study Completion: April 30, 2020
• Last Updated: April 3, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)