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

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ClinicalTrials.gov Identifier: NCT04164524
Recruitment Status : Completed
First Posted : November 15, 2019
Last Update Posted : November 20, 2019
Sponsor:
Information provided by (Responsible Party):
Shahida Parveen Afridi, Dow University of Health Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment
Wound With Foreign Body (With or Without Infection) 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.

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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Professor and HOD Department of Surgery DIMC
Actual Study Start Date : October 15, 2019
Actual Primary Completion Date : October 15, 2019
Actual Study Completion Date : October 15, 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Wound infection [ Time Frame: two weeks ]
    SSI Surgical site infection



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Two group Study population selected from Out patient Department for elective Surgery
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Emergency Admission incissional hernia inguinal hernia

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04164524


Locations
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Pakistan
Professor Shahida Parveen Afridi
Karachi, Sindh, Pakistan, 75270
Sponsors and Collaborators
Dow University of Health Sciences
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Responsible Party: Shahida Parveen Afridi, Professor of Surgery, Dow University of Health Sciences
ClinicalTrials.gov Identifier: NCT04164524    
Other Study ID Numbers: 1883
First Posted: November 15, 2019    Key Record Dates
Last Update Posted: November 20, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Through research paper
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 6 month
Access Criteria: email
Keywords provided by Shahida Parveen Afridi, Dow University of Health Sciences:
SSI
Wound infection
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Foreign Bodies
Wounds and Injuries
Gentamicins
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action