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

Sponsor

Muhammad Adeel Ashiq (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06129773

Collaborator

(none)

100

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Surgical Site Infection	Procedure: antibiotic coated vicryl used for fascial closure	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: anti biotic coated group	Procedure: antibiotic coated vicryl used for fascial closure in this group fascial closure was done with antibiotic coated vicryl to compare with non coated vicryl after lapaprotomy in contaminated wounds
No Intervention: non coated group

Arm

Intervention/Treatment

Experimental: anti biotic coated group

Procedure: antibiotic coated vicryl used for fascial closure

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

No Intervention: non coated group

Outcome Measures

Primary Outcome Measures

Rate of surgical site infection [30 days]
rate of surgical site infection will be measured in percentage

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Hours to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Muhammad Adeel Ashiq

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Muhammad Adeel Ashiq, Dr Muhammad Adeel Ashiq, Children Hospital and Institute of Child Health, Lahore

ClinicalTrials.gov Identifier:

NCT06129773

Other Study ID Numbers:

Adeel1

First Posted:

Nov 13, 2023

Last Update Posted:

Nov 13, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Muhammad Adeel Ashiq, Dr Muhammad Adeel Ashiq, Children Hospital and Institute of Child Health, Lahore

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

Additional relevant MeSH terms:

Surgical Wound Infection

Anti-Bacterial Agents

Study Results

No Results Posted as of Nov 13, 2023