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CompletedNCT04164524Updated Nov 20, 2019

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

An observational study in Wound With Foreign Body (With or Without Infection), sponsored by Dow University of Health Sciences. Completed at 1 site in Pakistan. Open to participants aged 25 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-11-20.

Sponsored by Dow University of Health Sciences · Observational

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Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
80
Ages
25 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 11 studies in Wound Infection with a site in Pakistan — 1 open to participants now, 1 under way, 1 of them phase 3. Wound Infection · Pakistan.

Started
2019
the only one that year
Observational
Only one
of the 11
Registered
1st of 11
by date
Lead sponsor
3 of 11
Dow University of Health Sciences

Among the 11 studies in Wound Infection with a site in Pakistan, this one is the only one that started in 2019, is the only observational one, and was the 1st registered.

Wound Infection

270 studies on the registry are indexed under Wound Infection; 33 are open to participants now.

Browse Wound Infection studies →

Open to participants now

1 of the 11 studies in Wound Infection with a site in Pakistan is open now. Recruiting first, the newest first:

A study can be open while its sites in Pakistan have not opened yet or have stopped. Only those recruiting at a site in Pakistan →

Who these studies take

Of the 23 Wound Infection studies recruiting now, 17 (74%) set no upper age limit and 1 (4%) stops at 75 or younger; 2 take children under 18; 2 take healthy volunteers.

This study: 25 Years to 60 Years · all sexes.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Wound With Foreign Body (With or Without Infection)

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Keywords

  • SSI
  • Wound infection
04

Who can participate

Ages eligible
25 Years to 60 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

Two group Study population selected from Out patient Department for elective Surgery

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

Emergency Admission incissional hernia inguinal hernia

-

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
80 participants (actual)
Patient registry
No

Groups and cohorts

  • Group; A

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

    Drug: Gentamycin

  • Group; B

    Open technique Hernioplasty for abdominal hernia in which no Gentamycin spray applied over the mesh

Interventions

  • Gentamycin 160 mg spray applied over the mesh

06

What researchers measure

Primary outcomes

  1. Wound infection

    SSI Surgical site infection

    Time frame: two weeks

07

Study locations

1 site
  • Professor Shahida Parveen Afridi
    Karachi, Sindh 75270, Pakistan
08

References and documents

Individual participant data

Plan to share: Yes — Through research paper

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

Time frame: 6 month

Access criteria: email

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2019 to primary completion in Oct 2019, 0 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 13, 2019
First posted
Nov 15, 2019
StartActual
Oct 15, 2019
Primary completionActual
Oct 15, 2019
CompletionActual
Oct 15, 2019
Last update
Nov 20, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04164524
Responsible party
Shahida Parveen Afridi (Professor of Surgery, Dow University of Health Sciences) — Principal investigator
First posted
Nov 15, 2019
Start date
Oct 15, 2019
Primary completion
Oct 15, 2019
Completion
Oct 15, 2019
Last update
Nov 20, 2019

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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