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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04164524
Recruitment Status : Completed
First Posted : November 15, 2019
Last Update Posted : November 20, 2019
Sponsor:
Information provided by (Responsible Party):
Shahida Parveen Afridi, Dow University of Health Sciences

Tracking Information
First Submitted Date November 13, 2019
First Posted Date November 15, 2019
Last Update Posted Date November 20, 2019
Actual Study Start Date October 15, 2019
Actual Primary Completion Date October 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 13, 2019)
Wound infection [ Time Frame: two weeks ]
SSI Surgical site infection
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Two group Study population selected from Out patient Department for elective Surgery
Condition Wound With Foreign Body (With or Without Infection)
Intervention Drug: Gentamycin
Gentamycin 160 mg spray applied over the mesh
Study Groups/Cohorts
  • Group; A
    Open technique Hernioplasty for abdominal hernia in which 160 mg Gentamycin spray applied over the mesh
    Intervention: Drug: Gentamycin
  • Group; B
    Open technique Hernioplasty for abdominal hernia in which no Gentamycin spray applied over the mesh
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 13, 2019)
80
Original Actual Enrollment Same as current
Actual Study Completion Date October 15, 2019
Actual Primary Completion Date October 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Emergency Admission incissional hernia inguinal hernia

-

Sex/Gender
Sexes Eligible for Study: All
Ages 25 Years to 60 Years   (Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Pakistan
Removed Location Countries  
 
Administrative Information
NCT Number NCT04164524
Other Study ID Numbers 1883
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Through research paper
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: 6 month
Access Criteria: email
Responsible Party Shahida Parveen Afridi, Dow University of Health Sciences
Study Sponsor Dow University of Health Sciences
Collaborators Not Provided
Investigators Not Provided
PRS Account Dow University of Health Sciences
Verification Date November 2019