NCT04164524

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2019

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 15, 2019

Completed
Last Updated

November 20, 2019

Status Verified

November 1, 2019

Enrollment Period

Same day

First QC Date

November 13, 2019

Last Update Submit

November 17, 2019

Conditions

Wound With Foreign Body (With or Without Infection)

Keywords

SSIWound infection

Outcome Measures

Primary Outcomes (1)

  • Wound infection

    SSI Surgical site infection

    two weeks

Study Arms (2)

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

GentamycinDRUG

Gentamycin 160 mg spray applied over the mesh

Group; A

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Emergency Admission incissional hernia inguinal hernia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Professor Shahida Parveen Afridi

Karachi, Sindh, 75270, Pakistan

Location

MeSH Terms

Conditions

Wound Infection

Interventions

Gentamicins

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

AminoglycosidesGlycosidesCarbohydrates

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

November 13, 2019

First Posted

November 15, 2019

Study Start

October 15, 2019

Primary Completion

October 15, 2019

Study Completion

October 15, 2019

Last Updated

November 20, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will share

Through research paper

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
6 month
Access Criteria
email

Locations

PA(1)