NCT06129773

Brief Summary

We are investigating outcome of antibiotic coated vicryl versus non coated vicryl in terms of rate of surgical site infection and lebgth of hospital stay in children after lalaprotomy for perforated viscera. total 100 patients will be taken and 50 in each group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2024

Completed
Last Updated

February 16, 2024

Status Verified

February 1, 2024

Enrollment Period

2 months

First QC Date

November 8, 2023

Last Update Submit

February 15, 2024

Conditions

Surgical Site Infection

Keywords

SSIs, anti biotic coated vicryl, laparotomy, Triclosan coated vicryl, Vicryl plus, Surgical site infection, Uncoated vicryl,

Outcome Measures

Primary Outcomes (1)

  • Rate of surgical site infection

    rate of surgical site infection will be measured in percentage

    30 days

Study Arms (2)

anti biotic coated group

EXPERIMENTAL
Procedure: antibiotic coated vicryl used for fascial closure

non coated group

NO INTERVENTION

Interventions

antibiotic coated vicryl used for fascial closurePROCEDURE

in this group fascial closure was done with antibiotic coated vicryl to compare with non coated vicryl after lapaprotomy in contaminated wounds

anti biotic coated group

Eligibility Criteria

Age4 Hours - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children with pneumoperitoneum / perforated viscus
  • Children aged 0 day to 15 years
  • Both genders

You may not qualify if:

  • Malnourished children
  • Children aged above 15 years
  • Clean surgeries
  • Low Hb level
  • Parents unwilling to take part

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children Hospital

Lahore, Punjab Province, 42000, Pakistan

Location

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr Muhammad Adeel Ashiq

Study Record Dates

First Submitted

November 8, 2023

First Posted

November 13, 2023

Study Start

November 1, 2023

Primary Completion

January 13, 2024

Study Completion

February 14, 2024

Last Updated

February 16, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)