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

NCT ID: NCT04164524

Last Updated: 2019-11-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-15
• Study Completion Date: 2019-10-15

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.

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.

Conditions

Wound With Foreign Body (With or Without Infection)

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Group; A

Open technique Hernioplasty for abdominal hernia in which 160 mg Gentamycin spray applied over the mesh

Gentamycin

Intervention Type: DRUG

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

No interventions assigned to this group

Interventions

Gentamycin

Gentamycin 160 mg spray applied over the mesh

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

Emergency Admission incissional hernia inguinal hernia

-

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dow University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Shahida Parveen Afridi

Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Professor Shahida Parveen Afridi

Karachi, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

1883

Identifier Type: -

Identifier Source: org_study_id