Frequency of Surgical Site Infection in Abdominal Hernia With Gentamycin Spray on Mesh Versus no Spray

Professor and HOD Department of Surgery DIMC

Patient diagnosed with Para umbilical hernia, umbilical hernia, epigastric will be selected for the study. Sampling technique will be systematic with every 2nd patient being exposed to Gentamycin spray during mesh repair. . Each procedure took 90 to 120 minutes approximately. All patients underwent open abdominal hernioplasty operated on elective list. After placing onlay polypropylene mesh fixed with 2-0 prolene and gentamicin 160 mg injection will be sprayed over the secured mesh. Close active suction drain will be placed in subcutaneous space. Finally we will close the skin with Prolene 2-0 with vertical mattress suture or stapler.

Study Overview

• Status: Completed
• Conditions: Wound With Foreign Body (With or Without Infection)
• Intervention / Treatment: Drug: Gentamycin

Detailed Description

Patients and methods:

The study will be conducted at Dow University Hospital Karachi, Ojha Campusa. The subjects included were elective patients operated for abdominal hernias. Sample size calculated for a larger study with 50% frequency, and 99% confidence levels, using Openepi was found to be 664. According to Connelly*, the sample size of pilot study should be 10% of the sample size of a larger pilot study. As it is a pilot study, the sample size for this study was found to be 66.

We will take the informed consent before including the patient in the study. Inclusion criteria Following hernia operated on elective list

• Para umbilical hernia
• Umbilical hernia
• Epigastric hernia

Exclusion criteria

• All above hernia operated in emergency
• Inguinal hernia

Sampling technique will be systematic with every 2nd patient being exposed to Gentamycin spray during mesh repair. . Each procedure took 90 to 120 minutes approximately. All patients underwent open abdominal hernioplasty operated on elective list. After placing onlay polypropylene mesh, fixed with 2-0 prolene and gentamicin 160 mg injection will be sprayed over the secured mesh. Close active suction drain will be placed in subcutaneous space. Finally skin will be close with Prolene 2-0 with vertical mattress suture or stapler. All patients discharge on a day care basis with follow-ups in the OPD Out patient Department for any post-operative SSI Surgical site infection for a period of two weeks. Drains will be remove once no or less than 20 ml serosanguinous/ serous discharge in 24 hours.

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75270
      • Professor Shahida Parveen Afridi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 60 years (ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Two group Study population selected from Out patient Department for elective Surgery

Description

Inclusion Criteria:

Elective surgery; Para umbilical hernia, umbilical and epigastric hernia,

Exclusion Criteria:

Emergency Admission incissional hernia inguinal hernia

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Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group; A; Open technique Hernioplasty for abdominal hernia in which 160 mg Gentamycin spray applied over the mesh	Drug: Gentamycin; Gentamycin 160 mg spray applied over the mesh
Group; B; Open technique Hernioplasty for abdominal hernia in which no Gentamycin spray applied over the mesh

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound infection	SSI Surgical site infection	two weeks

Collaborators and Investigators

• Sponsor: Dow University of Health Sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 15, 2019
• Primary Completion (ACTUAL): October 15, 2019
• Study Completion (ACTUAL): October 15, 2019

Study Registration Dates

• First Submitted: November 13, 2019
• First Submitted That Met QC Criteria: November 13, 2019
• First Posted (ACTUAL): November 15, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 20, 2019
• Last Update Submitted That Met QC Criteria: November 17, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Wound infection; SSI
• Additional Relevant MeSH Terms: Wounds and Injuries; Infections; Foreign Bodies; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Gentamicins
• Other Study ID Numbers: 1883

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Through research paper
• IPD Sharing Time Frame: 6 month
• IPD Sharing Access Criteria: email
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR