Management of Burst Abdomen | NCT07229703

Studies
Management of Burst Abdomen

NCT07229703

Sponsor

Zagazig University

Status

Completed

Last Update Posted

Nov 17, 2025Actual

Enrollment

252Actual

Phase

Not provided

Conditions

Burst Abdomen

Interventions

component separation
primary repair for burst abdomen

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2014Actual

Primary Completion Date

Jan 2020Actual

Completion Date

Sep 1, 2025Actual

First Submitted Date

Nov 13, 2025

First Submission Date that Met QC Criteria

Nov 13, 2025

First Posted Date

Nov 17, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 13, 2025

Last Update Posted Date

Nov 17, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this observational study is to learn about the long-term effects of repair of burst abdomen by both primary repair and component separation. The main question it aims to answer is:

Does component separation lower postoperative complications ?

Detailed Description

to compare between 2 common techniques for management of burst abdomen

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

252Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
component separation		management of burst abdomen by component separation	Procedure: component separation
primary repair		primary repair of burst abdomen	Procedure: primary repair for burst abdomen

Interventions

Name	Type	Description	Arm Group Labels	Other Names
component separation	Procedure	component separation for management of burst abdomen	component separation

Measure	Description	Time Frame
wound infection		30 days

Measure	Description	Time Frame
incisional hernia		5 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adult patients (≥18 years) underwent PCS+TAR+MA or primary suture with tension sutures for complete burst abdomen

Exclusion Criteria:

1. BA grade 1B, 2, 3, and 4 (n=17),
< 18 years (n=2)
Primary laparotomy performed through a non-midline incision (n=4)
Open abdomen (n=5)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

> 18 years with BA

Sampling Method

Probability Sample

Label	URL
Related Info	View source

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided