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CompletedNCT07350811APPABUUpdated Jan 20, 2026

Retrospective, Observationnal Study to Investigate Procedural Analgesia Delivered to Patients With Lacerations, Abrasions, Burns and Leg Ulcers.

An observational study in Skin Laceration, Skin Abrasion and Skin Burn, sponsored by Versailles Hospital. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-20.

Sponsored by Versailles Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
240
Ages
18 Years and older
Sex
All
01

Study summary

The main part of the study is a retrospective analysis of 200 reports concerning patients with skin wounds and injuries :

  • 50 consecutive patient reports dealing with skin lacerations
  • 50 consecutive patient reports dealing with skin abrasions
  • 50 consecutive patient reports dealing with skin burns
  • 50 consecutive patient reports dealing with leg ulcers

The study comprises a complementary prospective segment, consisting of data collection from patients and from care delivery personnel, threw short interviews, in order to assess the validity of the retrospective recording on reports.

Read the detailed description

The retrospective part of the study consists of data collection regarding care delivered to heal skin injuries.

For procedures performed in the emergency department (wound care, dermabrasions and burns), the main source of collection data will be the computerized emergency files that are completed by the doctors and that meet our objectives. For the care of leg ulcers, the main source of collection are records from vascular medicine consultations, and will be represented by the care files that are filled in by the nurses during the consultation.

In each of the four sections of the survey (wounds, dermabrasions, burns and leg ulcers), 50 "consecutive and correctly completed" acts will be included and will be collected.

Incomplete files (missing data on the procedures performed and/or treatments administered) will be replaced by the following ones in reverse chronological order. Inclusion will start with the most recent files and extend to the oldest ones. When the investigators have doubts about the understanding and correct interpretation of the information in the source files, they will discuss them with the careproviders, on an ad hoc basis and during the scheduled structured interviews.

The prospective part of the study consists of short guided interviews with patients (10-minute conversation with specific formated questions) and with care providers (15-minute conversation). The objective of the interviews is to validate, complete and/or correct the information collected threw patient reports.

02

Conditions studied

  • Skin Laceration
  • Skin Abrasion
  • Skin Burn
  • Leg Ulcer

Keywords

  • Procedural analgesia
  • Skin injuries
03

In context

Paresthesia

66 studies on the registry are indexed under Paresthesia; 14 are open to participants now.

This study's enrollment of 240 is above the median of 110 across 12 observational studies indexed under Paresthesia.

Browse Paresthesia studies →

Lead sponsor

Versailles Hospital is the lead sponsor of 74 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients with skin injuries (consulting emergency departments for skin laceration abrasion or burn, consulting vascular unit for patients with leg ulcer).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Main retrospective study: Adult patient with skin injury (laceration, abrasion, burn or skin ulcer) whose medical report is available.

Additionnal prospective interview: Adult patient with skin injury (laceration, abrasion, burn or skin ulcer) who consents to the 10-minute interview.

Exclusion criteria

Exclusion Criteria:

Main retrospective study: medical report incomplete. Additionnal prospective interview: Not french speaking.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
240 participants (actual)
Patient registry
No

Groups and cohorts

  • Procedural analgesia delivered to patients with dermabrasion

    Hospital reports of patients who were treated in the emergency deparment for skin abrasion

  • Procedural analgesia delivered to patients with skin burn

    Hospital reports of patients who were treated in the emergency department for skin burn

  • Procedural analgesia delivered to patients with leg ulcer

    Hospital reports of patients who were treated in the vascular department for leg ulcer

  • Procedural analgesia delivered to patients with skin lacerations

    Hospital reports of patients who were treated in the emergency deparment for skin lacerations

06

What researchers measure

Primary outcomes

  1. Pain level

    Pain level ≤ 3/10 (light or no pain) on a 10-point pain scale throughout the interval starting 30 minutes after treatment initiation and ending.

    Time frame: Up to 30 minutes

07

Study locations

1 site
  • Hospital Versailles
    Le Chesnay, 78150, France
08

References and documents

Individual participant data

Plan to share: No — Clinical, treatment and logistical data will be anonymously be recorded (ther will be no mention of age, gender, name, letters or numbers to identify participants): IPD will not be collected and therefore not shared.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07350811
Lead sponsor
Versailles Hospital
Responsible party
Kolia MILOJEVIC (Investigator Coordonnator, Versailles Hospital) — Principal investigator
First posted
Jan 20, 2026
Start date
Jun 11, 2024
Primary completion
Jan 15, 2025
Completion
Jul 15, 2025
Last update
Jan 20, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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