A Randomized Controlled Trial on Wound Irrigation in Open Appendectomy.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Role of Wound Irrigation After Appendectomy

NCT03773224

Appendicitis

COMPLETED NA

Water And Saline Head-to-head In The Blinded Evaluation Study Trial

NCT02714023

Acute Appendicitis Abscess

COMPLETED NA

Addition of Pre-wound Closure Povidone Iodine Wash Versus Direct Wound Closure Effect on Surgical Site Infections

NCT05077592

Surgical Site Infection Surgical Wound Infection

UNKNOWN PHASE4

Outcomes of High-volume Saline Irrigation VS Povidone-Iodine Solution Cleaning of IOWI in Preventing SSIs in Emergency Laparotomies

NCT05989386

Surgical Site Infection Surgical Wound Surgical Incision +5 more

RECRUITING PHASE2/PHASE3

Povidone-iodine and the Normal Saline Cleaning the Incision for the SSIs

NCT02436395

Surgical Site Infections Gastric Cancer Dehiscence of Laparotomy Wound

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Appendicitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Saline-gentamicin irrigation

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

Group Type ACTIVE_COMPARATOR

saline-gentamicin irrigation

Intervention Type PROCEDURE

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

Saline irrigation

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

Group Type ACTIVE_COMPARATOR

saline irrigation

Intervention Type PROCEDURE

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

No irrigation

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

saline-gentamicin irrigation

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

Intervention Type PROCEDURE

saline irrigation

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No