Clinical trial NCT04164524: Frequency of Surgical Site Infection in Abdominal Hernia With Gentamycin Spray on Mesh Versus no Spray
Official title: Professor and HOD Department of Surgery DIMC
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wound With Foreign Body (With or Without Infection)
Keywords: SSI
Wound infection
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2019-11-15
Enrollment: 80
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Two group Study population selected from Out patient Department for elective Surgery

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

Emergency Admission incissional hernia inguinal hernia

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Primary outcomes:
measure: Wound infection
timeFrame: two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Professor Shahida Parveen Afridi
state: Sindh
Study officials:
References: