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

Completed

• Conditions: Wound With Foreign Body (With or Without Infection)
• Interventions: Drug: Gentamycin

• Registration Number: NCT04164524
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2019-10-15
• Primary Completion: 2019-10-15
• Study Completion: 2019-10-15
• Status Verified: 2019-11
• Study First Submitted: 2019-11-13
• Study First Submitted QC: 2019-11-13
• Study First Posted: 2019-11-15
• Last Update Submitted: 2019-11-17
• Last Update Posted: 2019-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

Exclusion Criteria

Emergency Admission incissional hernia inguinal hernia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group; A	Gentamycin	Open technique Hernioplasty for abdominal hernia in which 160 mg Gentamycin spray applied over the mesh

Primary Outcome Measures

Name	Time	Method
Wound infection	two weeks	SSI Surgical site infection

Trial Locations

Locations (1)

Professor Shahida Parveen Afridi; 🇵🇰 Karachi, Sindh, Pakistan