Surgical Site InfectionNCT06129773
Comparison Of Outcome Of Antibiotic Coated Vicryl Vs Non-Coated Vicryl In Abdominal Fascial Closure After Laparotomy In Children
A study testing antibiotic coated vicryl used for fascial closure in people with Surgical Site Infection, run by Muhammad Adeel Ashiq at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 hours to 15 years
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- antibiotic coated vicryl used for fascial closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2023to 14 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 hours to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- • Children with pneumoperitoneum / perforated viscus
- Children aged 0 day to 15 years
- Both genders
Who cannot join
- • Malnourished children
- Children aged above 15 years
- Clean surgeries
- Low Hb level
- Parents unwilling to take part
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Surgical Site Infection
- Being tested
- antibiotic coated vicryl used for fascial closure
- Keywords
- SSIs, anti biotic coated vicryl, laparotomy, Triclosan coated vicryl, Vicryl plus, Surgical site infection, Uncoated vicryl,
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antibiotic coated vicryl used for fascial closureProcedure or surgery
in this group fascial closure was done with antibiotic coated vicryl to compare with non coated vicryl after lapaprotomy in contaminated wounds
| Study group | Role | What they receive |
|---|---|---|
| anti biotic coated group | Experimental | Not described Receives: Procedure: antibiotic coated vicryl used for fascial closure |
| non coated group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of surgical site infection
rate of surgical site infection will be measured in percentage
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start1 Nov 2023
- Primary completion13 Jan 2024
- Study completion14 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammad Adeel Ashiq
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammad Adeel Ashiq, Children Hospital and Institute of Child Health, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06129773
- Sponsor's protocol ID
- Adeel1
- Status last verified
- Feb 2024
- First submitted
- 8 Nov 2023
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Outcome Of Antibiotic Coated Vicryl Vs Non-Coated Vicryl In Abdominal Fascial Closure After Laparotomy In Children
- ClinicalTrials.gov ID
- NCT06129773
- Acronym / sponsor ID
- Adeel1
- Conditions
- Surgical Site Infection
- Keywords
- SSIs, anti biotic coated vicryl, laparotomy, Triclosan coated vicryl, Vicryl plus, Surgical site infection, Uncoated vicryl,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Muhammad Adeel AshiqUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 13 Jan 2024 (actual)
- Study completion
- 14 Feb 2024 (actual)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anti biotic coated group | Experimental | Procedure: antibiotic coated vicryl used for fascial closure |
| non coated group | No intervention | – |
Who may qualify
- Ages
- 4 hours to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- • Children with pneumoperitoneum / perforated viscus
Key exclusion criteria (5 listed)
- • Malnourished children
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antibiotic coated vicryl used for fascial closurein this group fascial closure was done with antibiotic coated vicryl to compare with non coated vicryl after lapaprotomy in contaminated wounds | Procedure or surgery | anti biotic coated group |
Primary outcome
Rate of surgical site infection
Time frame: 30 days
rate of surgical site infection will be measured in percentage
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing antibiotic coated vicryl used for fascial closure in people with Surgical Site Infection, run by Muhammad Adeel Ashiq at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of surgical site infection (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024.