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

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.

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Key information

Conditions

Wound With Foreign Body (With or Without Infection) Infections Wound Infection

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Professor Shahida Parveen Afridi

Karachi, Sindh, 75270, Pakistan

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Emergency Admission incissional hernia inguinal hernia

Treatment and study plan

Gentamycin

Drug

Gentamycin 160 mg spray applied over the mesh

Primary outcomes

Wound infection

Time frame: two weeks

SSI Surgical site infection

Sponsors and collaborators

Lead sponsor

Dow University of Health Sciences

Other

Registry information

Official study title

Professor and HOD Department of Surgery DIMC

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2019
First posted: Nov 15, 2019
Registry last updated: Nov 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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