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OpenTrials
Completed

NCT Number: NCT06129773

Comparison Of Outcome Of Antibiotic Coated Vicryl Vs Non-Coated Vicryl In Abdominal Fascial Closure After Laparotomy In Children

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.

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Key information

Age range

4 hour–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Children Hospital

Lahore, Punjab Province, 42000, Pakistan

About this study

Pneumoperitoneum is typically a surgical emergency, particularly in children and more than 90% of occurrences are caused by perforation of the gastrointestinal tract and other hollow viscera. Wound infections after abdominal surgery are still frequent types of nosocomial infections. Sutures can be a source of wound infection and dehisence due to bacterial adherence and colonization. Sutures coated with antibacterial agents have been developed in an attempt to reduce bacterial adherence and colonization of suture materials. The objective of the study is to compare the outcome of antibiotic coated vicryl versus non-coated vicryl in abdominal fascial closure after laparotomy in children in regards of surgical site infections. It will be a randomized controlled trial in which 100 patients admitted in Children Hospital Lahore will be included. Simple random sampling will be carried out. Informed written consent will be taken from patients' guardian. The patients will be divided into two groups (50 in each group). Group-A patients will undergo laparotomy closure with antibiotic coated vicryl while Group-B patient will experience non-coated vicryl in abdominal fascial closure. All patients will be examined on 3rd, 7th and 30th post-operative day for wound infection according to Southampton wound scoring system. Data will be collected through predesigned proforma, which will be entered and statistically analyzed using SPSS version 24.0. For quantitative variables mean and standard deviation will be calculated and for qualitative variables frequency and percentages will be calculated. Data will be presented in tables and graphs. Chi-square test will be used to estimate the association between qualitative variables. P-value <0.05 will be considered significant. It is expected that results of this study may be helpful for healthcare providers to provide appropriate treatment to the patients and to prevent them from wound related complications.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

antibiotic coated vicryl used for fascial closure

Procedure

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

Primary outcomes

  1. Rate of surgical site infection

    Time frame: 30 days

    rate of surgical site infection will be measured in percentage

Sponsors and collaborators

Lead sponsor

Muhammad Adeel Ashiq

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 13, 2023
Registry last updated
Feb 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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