Interest of Skin Graft Pellets in the Management of Ulcers Algic

Ulcer, Leg Clinical Trial

— ULCERALGIQUE  

Official title:

Interest of Skin Graft Pellets in the Management of Ulcers Algic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02904707
• Other study ID #: ULCERALGIQUE
• Status: Completed
• Start date: February 2015
• Est. completion date: May 2015

Study information

• Verified date: September 2016
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Leg ulcers (UDJ) is defined as a chronic skin wound, lasting for more than 4 to 6 weeks, between the knee and foot, and with no tendency to spontaneous healing.

In 2002, the prevalence of leg ulcers is estimated between 0.5% and 1% of the general population and 3% in subjects over 65 years.

The sex ratio is generally 3 females to 1 male. It is in most cases a complication of vascular disease, usually venous (70 to 90%), then blood (5-15%), mixed (5-10%) and microcirculatory.

In three quarter of cases, the UDJ is a chronic painful wound to the social repercussions (sleep disorders, eating, work stoppages) and major economic (individual and collective costs of absorptions).

The treatment of a chronic wound uses validated techniques for several years as the skin graft in tablets, associated with the etiological treatment.

The latest recommendations HAS implemented to date from 2006 and concerns the management of leg ulcers predominantly venous.

Few articles in the literature address the possibility of an analgesic effect of the transplant pellets in the treatment of chronic ulcers algic.

In 2008, a Swedish article, evaluated pain before and after skin grafting in carriers of leg ulcer patients and feet and showed that there was a reduction in pain post transplant.

We propose to evaluate the analgesic effect of the skin graft in pellet on a patient population having one or more Algic ulcers.

Description:

Development of the study:

An information note and the non-opposition of the patient will be collected on the first day of hospitalization. The written and signed consent will be recorded in the patient record.

Clinical data will be collected during hospitalization of the patient, respecting his anonymity only initials and year of birth will be made in terms of data that distinguish patients.

The EQ-5D questionary will be distributed at the beginning of hospitalization and completed by each patient, and will evaluate the impact of painful ulcers in their daily lives.

Finally, a pain assessment questionary by NE (Numeric Evaluation) before and after the skin graft pellet, will be filled by a caregiver during an interview with each patient.

Methodology :

Design: open, prospective, single centric (Vascular Medicine Department), Interventional.

The data to be collected are:

The age, sex, weight, height Length of hospitalization, The type of ulcer, the size of the ulcer disease duration of current or ulcers, duration of ulcer disease The graft antecedent, number of grafts placed in the registry, the date of completion of the graft, The evaluation of pain before and after the completion of the graft on EN, The impact of pain on patient's quality of sleep, the type of pain experienced by patients in terms of their ulcers

The type and number of analgesics taken by patients:

• Antiepileptic therapy (pregabapentine, gabapentin)

• Analgesic treatment to alleviate I (paracetamol), to overcome II (codeine paracetamol, Lamaline, tramadol, nefopam, Ixprim), and compensate III (morphine, opiates).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Inpatient consecutively

• over 18 years old, man, woman,

• having one or more ulcers of venous, arterial or microcirculatory

• for more than four to six weeks

• answering yes to the question: is it painful ulcer?

• consultant in vascular medicine department of St. Joseph hospital in February the month of April 2015

Exclusion Criteria:

• Patients minors

• Patients with dementia

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Ulcer Algic
• Ulcer, Leg

Intervention

Other:
• Questionary EQ-5D
In addition to the pain questionary that is filled filled as usual, the EQ-5D questionary will be distributed at the beginning of hospitalization and completed by each patient, and will evaluate the impact of painful ulcers in their daily lives.

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint Joseph	Paris	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of change of pain by Numeric Evaluation Scale	A pain assessment questionnaire by Numeric Evaluation Scale NE (pain rating scale measuring pain intensity from 0 to 10) before and after the skin graft pellet, will be filled by a caregiver during an interview with each patient	Day -1, Day 1 and Day 7
Secondary	Assessment of change of the impact of painful ulcers usin EQ-5D Questionary	The EQ-5D questionnaire will be distributed at the beginning of hospitalization and completed by each patient, and will evaluate the impact of painful ulcers in their daily lives.	Day -1, Day 1 and Day 7