Professor and HOD Department of Surgery DIMC
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Wound infection
Study Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 25 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Elective surgery; Para umbilical hernia, umbilical and epigastric hernia,
Exclusion Criteria
- •Emergency Admission incissional hernia inguinal hernia
Arms & Interventions
Group; A
Open technique Hernioplasty for abdominal hernia in which 160 mg Gentamycin spray applied over the mesh
Intervention: Gentamycin (Drug)
Outcomes
Primary Outcomes
Wound infection
Time Frame: two weeks
SSI Surgical site infection
Secondary Outcomes
No secondary outcomes reported
Investigators
Shahida Parveen Afridi
Professor of Surgery
Dow University of Health Sciences