Skin LacerationAPPABUNCT07350811
Retrospective, Observationnal Study to Investigate Procedural Analgesia Delivered to Patients With Lacerations, Abrasions, Burns and Leg Ulcers.
An observational study of Skin Laceration and Skin Abrasion, run by Versailles Hospital at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Laceration, Skin Abrasion, Skin Burn
- How many people
- 240 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jun 2024to 15 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with skin injuries (consulting emergency departments for skin laceration abrasion or burn, consulting vascular unit for patients with leg ulcer).
Who may be able to join
- 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.
Who cannot join
- Main retrospective study: medical report incomplete. Additionnal prospective interview: Not french speaking.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Skin Laceration, Skin Abrasion, Skin Burn, Leg Ulcer
- Keywords
- Procedural analgesia, Skin injuries
- Medical subject headings
- Paresthesia, Leg Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start11 Jun 2024
- Primary completion15 Jan 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin LacerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Versailles Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kolia MILOJEVIC, Versailles Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350811
- Sponsor's protocol ID
- P24/05 - APPABU
- Acronym
- APPABU
- Status last verified
- Jan 2026
- First submitted
- 6 Nov 2024
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07350811
- Acronym / sponsor ID
- APPABU / P24/05 - APPABU
- Conditions
- Skin Laceration, Skin Abrasion, Skin Burn, Leg Ulcer
- Keywords
- Procedural analgesia, Skin injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Versailles HospitalUniversity, hospital or other
- Study start
- 11 Jun 2024 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with skin injuries (consulting emergency departments for skin laceration abrasion or burn, consulting vascular unit for patients with leg ulcer).
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Main retrospective study: medical report incomplete. Additionnal prospective interview: Not french speaking.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain level
Time frame: Up to 30 minutes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Laceration and Skin Abrasion, run by Versailles Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level (time frame: Up to 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.