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

Retrospective and Observational Category 3 Study to Investigate Procedural Analgesia Delivered to Patients With Skin Injury, Aiming to Describe and Quantify Therapeutic Pain Control Procedures Addressing Skin Lacerations, Abrasions, Burns and Leg Ulcers.

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.

Study Overview

• Status: Completed
• Conditions: Leg Ulcer; Skin Burn; Skin Abrasion; Skin Laceration

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.

• Study Type: Observational
• Enrollment (Actual): 240

Contacts and Locations

Study Locations

• France
  • Le Chesnay, France, 78150
    • Hospital Versailles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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).

Description

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:

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 30 minutes

Collaborators and Investigators

• Sponsor: Versailles Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2024
• Primary Completion (Actual): January 15, 2025
• Study Completion (Actual): July 15, 2025

Study Registration Dates

• First Submitted: November 6, 2024
• First Submitted That Met QC Criteria: January 9, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Procedural analgesia; Skin injuries
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Skin Diseases; Skin Ulcer; Sensation Disorders; Somatosensory Disorders; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Signs and Symptoms; Leg Ulcer; Paresthesia
• Other Study ID Numbers: P24/05 - APPABU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No