Wound DehiscenceNCT05963477
Pediatric Post-operative Abdominal Wound Dehiscence in Association With Midline vs Other Incisions: A Prospective Cohort Study
An observational study of Wound Dehiscence and Incision, run by French Medical Institute for Mothers and Children at 1 site in Afghanistan.
Trial summary
This study is designed to see different abdominal incisions complication among neonates, infants and children and to find risk factors for developing wound dehiscence Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Wound Dehiscence, Incision
- What is being tested?
- laparatomy
- Type of treatment
- Surgery or procedure
- How many people
- 270 participants
- Where
- 1 siteAfghanistan
- Study dates
- 1 Nov 2018to 30 Jun 2020
- Phase
- Observational
- 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 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: all patients from neonatal age until 18 years old who were planned to undergo abdominal surgery.
Who may be able to join
- -all abdominal surgeries patient under 18-year-old.
Who cannot join
- Umbilical hernia, redo laparatomy, laparoscopic surgery.
Trial locations and contacts
1 site in 1 country.
Afghanistan1 site
French Medical Institute for Mothers and Children
Kabul, 1006
About this study
Official title: Pediatric Post-operative Abdominal Wound Dehiscence in Association With Midline vs Other Incisions in Tertiary Care Setting Kabul Afghanistan: A Cohort Study
This study is designed to see different abdominal incisions complication among neonates, infants and children and to find risk factors for developing wound dehiscence
- Conditions
- Wound Dehiscence, Incision
- Being tested
- laparatomy
- Keywords
- abdominal wound dehiscence, burst abdomen, pediatric abdominal incisions, children
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparatomyProcedure or surgery
all abdominal procedures which are approached by different incisions
| Study group | Role | What they receive |
|---|---|---|
| Age Group | Neonates Infants Children Receives: Procedure: laparatomy | |
| Gender | Male Female Receives: Procedure: laparatomy | |
| Selective/Emergency | Selective Emergency Receives: Procedure: laparatomy | |
| Wound Class | Clean Clean-contaminated Contaminated Infected Receives: Procedure: laparatomy | |
| Risk Factors | Yes No Receives: Procedure: laparatomy | |
| Type of Incisions | Midline Trransverse Oblique Receives: Procedure: laparatomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound dehiscence or burst abdomen
the overall outcome of the intervention (incisions) is wound dehiscence in different age groups, in gender, among who has or has no risk factors and among different wound class
Measured: one month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Nov 2018
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound DehiscenceStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Medical Institute for Mothers and Children
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Abdullah Bahloli, French Medical Institute for Mothers and Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05963477
- Sponsor's protocol ID
- 40-FMIC-ER-18
- Status last verified
- Jul 2023
- First submitted
- 19 Jul 2023
- Last updated
- 27 Jul 2023
- 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 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Post-operative Abdominal Wound Dehiscence in Association With Midline vs Other Incisions in Tertiary Care Setting Kabul Afghanistan: A Cohort Study
- ClinicalTrials.gov ID
- NCT05963477
- Acronym / sponsor ID
- 40-FMIC-ER-18
- Conditions
- Wound Dehiscence, Incision
- Keywords
- abdominal wound dehiscence, burst abdomen, pediatric abdominal incisions, children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- French Medical Institute for Mothers and ChildrenOther government
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 27 Jul 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.
This study is designed to see different abdominal incisions complication among neonates, infants and children and to find risk factors for developing wound dehiscence
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Age Group | – | Procedure: laparatomyNeonates Infants Children |
| Gender | – | Procedure: laparatomyMale Female |
| Selective/Emergency | – | Procedure: laparatomySelective Emergency |
| Wound Class | – | Procedure: laparatomyClean Clean-contaminated Contaminated Infected |
| Risk Factors | – | Procedure: laparatomyYes No |
| Type of Incisions | – | Procedure: laparatomyMidline Trransverse Oblique |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- all patients from neonatal age until 18 years old who were planned to undergo abdominal surgery.
Key inclusion criteria (1 listed)
- -all abdominal surgeries patient under 18-year-old.
Key exclusion criteria (1 listed)
- Umbilical hernia, redo laparatomy, laparoscopic surgery.
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 |
|---|---|---|
| laparatomyall abdominal procedures which are approached by different incisions | Procedure or surgery | Age Group, Gender, Risk Factors, Selective/Emergency, Type of Incisions, Wound Class |
Primary outcome
Wound dehiscence or burst abdomen
Time frame: one month after intervention
the overall outcome of the intervention (incisions) is wound dehiscence in different age groups, in gender, among who has or has no risk factors and among different wound class
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 27 Jul 2023.
- 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?
An observational study of Wound Dehiscence and Incision, run by French Medical Institute for Mothers and Children at 1 site in Afghanistan.
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 1 inclusion and 1 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 27 Jul 2023. 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 Afghanistan. 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?
Wound dehiscence or burst abdomen (time frame: one month after intervention). 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 27 Jul 2023.