NCT05510362

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 8, 2022

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 19, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 22, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2025

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

2.8 years

First QC Date

August 19, 2022

Last Update Submit

March 14, 2024

Conditions

Keywords

woundssuperinfectionsstitches

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age1 Year - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nouira

Monastir, 5060, Tunisia

RECRUITING

MeSH Terms

Conditions

Wounds and InjuriesSuperinfection

Condition Hierarchy (Ancestors)

Opportunistic InfectionsInfections

Study Officials

  • Bel Haj Ali A Khaoula, MD

    CHU Fattouma Bourguiba Monastir, service des urgences

    STUDY DIRECTOR

Central Study Contacts

Bel Haj ALI Khaoula, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

August 19, 2022

First Posted

August 22, 2022

Study Start

August 8, 2022

Primary Completion

June 8, 2025

Study Completion

October 10, 2025

Last Updated

March 15, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations