ActiV.A.C.+ Compression Therapy Versus Compression Therapy Alone for the Treatment of Chronic Venous Ulcerations

Summary

This is a prospective, randomized, comparative interventional human subject trial. Patients with a chronic venous ulceration of the lower extremity will be enrolled into this study. These wounds must be recalcitrant to the standard treatment regimen. There are a total of two arms in this study. One group will be randomly assigned to receive Vacuum Assisted Closure (V.A.C. or VAC) by means of the ActiV.A.C. + Compression therapy group consisting of the application of this device along with compression therapy. The other group will be randomly assigned into compression therapy only group. A total of 60 subjects will be enrolled into this 6 week study. There will be a 2 week run-in period (prior to the onset of the intervention) to ensure that the wound has not healed greater than 35% prior to intervention and randomization. Wounds that heal within the 6 week trial period will have an additional confirmatory visit 2 weeks after healing was identified.

If within the 6 week intervention period the wound bed is determined to be ready for a Split Thickness Skin Graft (STSG) or Bio-engineered Alternative Tissue (BAT), the surgery or clinic application will be scheduled within 4 weeks. Subjects deemed not to be a surgical candidate, will have Bio-engineered Alternative Tissue (BAT) application in the clinic. This includes patients who are medically unstable to receive a medical clearance for surgery or otherwise not a candidate for Split Thickness Skin Graft (STSG) surgery (e.g. donor site skin is compromised). During this period between the scheduled STSG surgery or BAT application, the subjects will continue within the assigned treatment group. A confirmatory visit will also occur 2 weeks after the application of a Split Thickness Skin Graft (STSG) or Bio-engineered Alternative Tissue (BAT).

Patients diagnosed with a chronic venous ulceration will be assessed for study eligibility during their initial clinical evaluation. Patients who meet the eligibility requirements will be asked to enroll into the study (see Subject Recruitment). Subjects will be asked to sign the informed consent form and receive a copy of the informed consent.

Conditions

• Chronic Venous Hypertension With Ulcer

Interventions

DEVICE

ActiVAC System

The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.

OTHER

Compression therapy

Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations.

Sponsors & Collaborators

• Georgetown University

  lead OTHER

Principal Investigators

• Christopher Attinger, M.D · Georgetown University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-07-31

Primary Completion

2014-03-31

Completion

2014-03-31

Countries

• United States

Study Locations