Comparison of the Use of VAC System in Transplants of Leg Ulcers Versus Usual Dressing Method

NCT02509533 | Terminated

• 2 other identifiers: 10080422010-A00371-38
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the VAC (Vacuum Assisted Closure) therapy in transplants of leg ulcers versus usual dressing method. The VAC Therapy system consists of:

• A unit delivering a precise under atmospheric pressure, controlled and regulated in the wound site,
• Consumables necessary for the implementation of the dressing,
• Collecting tanks exudates with gel. VAC therapy is a system using negative pressure. It is known to be efficient into care of chronic wounds and ulcerous wounds by increasing the cicatrisation. This system is systematically used into the dermatology unit of the CHU of Saint-Etienne after transplants of leg ulcers, but no data confirms the interest of this method compared to usual dressing method. This study will provide this data.

Conditions

Leg Ulcer

Keywords

Vacuum Assisted Closure

Outcome Measures

Primary Outcomes (1)

• Percentage of healing between VAC system and compresses for all types of leg ulcers

  Number of patients having a wound at least 50% of the grafted area between VAC system and compresses

  1 month after the transplant

Secondary Outcomes (9)

• Percentage of healing between VAC system and compresses for all types of leg ulcers

  3 months after the transplant

• Evolution of the pain by Analogic Visual Scale.

  day 0 : just before the transplant

• Evolution of the pain by Analogic Visual Scale.

  day 1 : the day after the transplant

• Evolution of the pain by Analogic Visual Scale

  Month 1

• Quality of life questionnaire score.

  day 0 : just before the transplant

Study Arms (2)

V.A.C.® Therapy

EXPERIMENTAL

In this arm, investigators will use the V.A.C.® Therapy after a transplants of leg ulcers.

Device: V.A.C.®

usual dressing method (compresses)

ACTIVE COMPARATOR

In this arm, investigators will use the usual dressing method after a transplants of leg ulcers.

Device: dressing

Interventions

V.A.C.® DEVICE

Patients received V.A.C.® Therapy (KCI medical) after a transplants of leg ulcers.

V.A.C.® Therapy

dressing DEVICE

Patients received usual dressing method (compresses) after a transplants of leg ulcers

usual dressing method (compresses)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient hospitalized into the dermatology unit
• patient with an evolutive leg ulcer since more than 1 month
• signed informed consent

You may not qualify if:

• known allergy to one of dressings used in this study
• patient with a non-treated osteomyelitis
• patient with tumoral tissues into the wound
• patient with raw organ or raw blood vessels
• patient with an anticoagulation treatment with a potentially hemorrhagic curative dose
• patient having hemostasis problems that can lead to hemorrhagic exudates

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de SAINT-ETIENNE

Saint-Etienne, 42000, France

Location

MeSH Terms

Conditions

Leg Ulcer

Interventions

Bandages

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Bruno LABEILLE, MD

  CHU de SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2015
• First Posted: July 28, 2015
• Study Start: September 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: March 1, 2014
• Last Updated: July 28, 2015

Record last verified: 2015-07

Locations

FR (1)