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

Wound With Foreign Body (With or Without Infection) Clinical Trial

Official title:

Professor and HOD Department of Surgery DIMC

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04164524
• Other study ID #: 1883
• Status: Completed
• Start date: October 15, 2019
• Est. completion date: October 15, 2019

Study information

• Verified date: November 2019
• Source: Dow University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 15, 2019
• Est. primary completion date: October 15, 2019
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Emergency Admission incissional hernia inguinal hernia

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Related Conditions & MeSH terms

• Communicable Diseases
• Foreign Bodies
• Infection
• Wound With Foreign Body (With or Without Infection)

Intervention

Drug:
• Gentamycin
Gentamycin 160 mg spray applied over the mesh

Locations

Country	Name	City	State
Pakistan	Professor Shahida Parveen Afridi	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound infection	SSI Surgical site infection	two weeks