Management and Short Term Outcome of Traumatic Wounds in... | NCT05510362

Studies
Management and Short Term Outcome of Traumatic Wounds in the Emergency Department

NCT05510362

Sponsor

University of Monastir

Status

Unknown status

Last Update Posted

Mar 15, 2024Actual

Enrollment

3,000Estimated

Phase

Not provided

Conditions

Wound Heal

Interventions

Not provided

Countries

Tunisia

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

Mar 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 8, 2022Actual

Primary Completion Date

Jun 8, 2025Estimated

Completion Date

Oct 10, 2025Estimated

First Submitted Date

Aug 19, 2022

First Submission Date that Met QC Criteria

Aug 19, 2022

First Posted Date

Aug 22, 2022Actual

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

Mar 14, 2024

Last Update Posted Date

Mar 15, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Identify the risk factors for complications as well as study the evolution of wounds sutured in the emergency room towards complications such as superinfections, necrosis, disunity of the stitches linked to inadequate initial care.

Detailed Description

All traumatic injuries should be considered contaminated upon presentation to the emergency room. This is why the main objective of this study was to describe the attitude of patients towards their wounds, to identify the risk factors for complications as well as to study the evolution of sutured wounds in the emergency room towards complications such as superinfections, necrosis, disunity of stitches linked to inadequate initial treatment.

This is a prospective, observational, monocentric study carried out in the emergency services of the Fattouma Bourguiba hospital in Monastir.

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

3,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evolution of the wound and the healing period.	After discharge from ED patients were called back in order to know information about the Suture complications(infection, release of stitches, hematoma, etc.)	day 10

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who presented to the ambulatory emergency circuit of the EPS Fattouma Bourguiba Monastir having as main reason for consultation an acute suturable wound.

Exclusion Criteria:

Wounds requiring surgical treatment
Septic wounds
Chronic lesions
Vascular wounds
Patients who did not consent to the protocol.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

90 Years

Standard Ages

ChildAdultOlder Adult

Study Population

All patients with an acute suturable wound and accept to enroll the study .

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bel Haj ALI Khaoula, MD	Contact	29777277	216	belhajalikhaoula@yahoo.fr

Overall Officials

Name	Affiliation	Role
Bel Haj Ali A Khaoula, MD	CHU Fattouma Bourguiba Monastir, service des urgences	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nouira	Recruiting	Monastir		5060	Tunisia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014947	Wounds and Injuries
D015163	Superinfection

Ancestor Terms

ID	Term
D009894	Opportunistic Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided