A

Dear A, Great Question.  The first decision I make when choosing negative pressure (VAC) for venous etiology wounds is which types of venous wounds I would exclude. Limiting conditions or symptoms include:

1. Infection, or an inflammatory reaction along the periwound or the extremity itself.

Note: while infection of venous wounds does occur it is often mistaken as the lone cause of redness along the extremity or peri-area of the wound. More commonly, this redness (erythemia) is related to an inflammatory process common with venous wounds (see a great explanation below*). If this problem is preventing the application of Wound Vac therapy then I recommend a Medrol dose pack which typically does this trick in reducing the inflammatory process.

2. Fragile or weeping skin tissue proceeding from the borders of the wound out to the greater part of the lower extremity (disallowing adhesion of wound vac drape or duoderm thin without the further opening of wounds along the extremity).

This being said, you can treat fragile or weeping skin just a few inches away from the wound with a few simple tricks.

First, on outright weeping skin a recommend a layering process that starts with the application of Non-sting skin prep followed by anti-fungal powder.  Alternatively repeating (at least 10 repeated applications) the application of these two products achieves two goals as the weeping areas are covered in a way that limits their drainage and the skin prep provides a great tacky surface for which the wound drape to adhere.

Second, along the edges beyond the weeping or fragile skin tissue place a Duoderm thin (ConvaTec). I have found that Duoderm Thin is about the only dressing that prevents the fluid from working its way under it a high draining wound with or without NPWT.  I also recommend placing stoma paste (ConvaTec) in the trenches of skin that the Duoderm Thin can’t secure to (See the following image). Once hardened place the Duoderm Thin over the Stoma Paste.

Finally, at this point place the VAC Foam in the wound bed. I recommend the  the V.A.C.^® GranuFoam™ Bridge Dressing (See Picture Below). This dressing allows you to concisely weave the pre-sized bridge dressing through the multilayer compression dressing. When applying the wound drape place skin prep to skin (that is intact) and over the Duoderm Thin to provide a more wound drape dressing.

“Venous reflux (or valve failure) or other vein conditions can lead to increased pooling of blood, causing venous hypertension (increased pressures in the veins of the lower leg), which leads to the pooling of blood. These venous conditions may come from more superficial veins (like varicose veins), deeper veins (related to deep vein thrombosis or DVT) or from perforator veins, which connect the veins of the superficial and deep vein systems. When these high pressure conditions exist, fluid can leak out into the surrounding tissues, inflammation of the tissues occurs, and the normal transfer of nutrients and oxygen to the tissues is impaired. Over time, the diminished level of nutrients and oxygen and the inflammation created causes damage to the surrounding tissues, which can result in skin discoloration and tissue death” (retrieved from www.veintreatment.com).

Best Wishes,

Matthew Livingston RN

Author of the Scottsdale Wound Management Guide

This is a letter from Jeffrey E. Shuren, MD, JD of the FDA regarding Complications with NPWT. There are two tables at the bottom of the letter that are important reminders of what we as clinicians should consider each time we place NPWT on a patient.

The article was written by:

Jeffrey E. Shuren, MD, JD
Acting Director
Center for Devices and Radiological Health
Food and Drug Administration

Date: November 13, 2009

Dear Healthcare Practitioner:

This is to alert you to deaths and serious complications, especially bleeding and infection, associated with the use of Negative Pressure Wound Therapy (NPWT) systems, and to provide recommendations to reduce the risk. Although rare, these complications can occur wherever NPWT systems are used, including acute and long-term healthcare facilities and at home. FDA has received reports of six deaths and 77 injuries associated with NPWT systems over the past two years.

Recommendations

Select patients for NPWT carefully, after reviewing the most recent device labeling and instructions. Know that:

• NPWT systems are contraindicated for certain wound types (Table 1), and
• Patient risk factors (Table 2) must be thoroughly considered before use.

Assure that the patient is monitored frequently in an appropriate care setting by a trained practitioner. In determining the frequency of monitoring, consider the patient’s condition, including the wound status, wound location and co-morbidities.

Be vigilant for potentially life-threatening complications, such as bleeding, and be prepared to take prompt action if they occur.

Obtain appropriate training prior to prescribing and using NPWT.

If the patient is determined a proper candidate for using the NPWT system at home:

• Instruct the patient and/or caregiver about how to use the system, potential complications and their signs/symptoms, and what to do if complications occur.
• Request that the patient and/or caregiver demonstrate use of the system, and document his/her proficiency.
• Assure that the patient and/or caregiver understands the warnings associated with NPWT system use.

• Provide the patient with a written copy of the patient labeling from the NPWT system manufacturer, if available. Encourage the patient to keep these materials and instructions for use readily accessible.

In addition, an Advice for Patients can be found on the FDA Consumer website.

Background on NPWT

NPWT systems are generally indicated for the management of wounds, burns, ulcers, flaps and grafts. They apply negative pressure to the wound in order to remove fluids, including wound exudates, irrigation fluids, and infectious materials. They are contraindicated in the presence of exposed anastomotic sites, exposed vasculature, exposed nerves, exposed organs, necrotic tissue with eschar present, untreated osteomyelitis, non-enteric and unexplored fistulas, and malignancy in the wound.

NPWT systems consist of the following components: an apparatus that generates vacuum and is capable of creating a negative pressure environment within a sealed wound; dressing materials used to pack the wound and seal it; a conduit for fluid removal from the wound bed; and a container/canister to collect waste materials that are removed from the wound bed via suction.

Reports received by FDA

In the last two years, FDA received six death and 77 injury reports associated with NPWT systems. Most of the deaths reported to FDA occurred at home or in a long-term care facility. Bleeding was the most serious complication and was reported in six death and 17 injury reports. Extensive bleeding occurred in patients with vascular grafts (such as femoral and femoral-popliteal grafts), in sternal and groin wounds, in patients receiving anti-coagulant therapy, and during removal of dressings that adhered to or were imbedded in the tissues. Patients with bleeding required emergency room visits and/or hospitalization and were treated with surgical procedures and blood transfusions.

Twenty-seven reports indicated infection from original open infected wounds or from retention of dressing pieces in the wound. Retention of foam dressing pieces and foam adhering to tissues or imbedded in the wound were noted in 32 injury reports. The majority of these patients required surgical procedures for removal of the retained pieces, wound debridement, and treatment of wound dehiscence, as well as additional hospitalization and antibiotic therapy.

FDA will continue to monitor adverse events associated with these products, and will make available any new information that might affect their use.

Reporting adverse events

FDA requires hospitals and other user facilities to report deaths and serious injuries associated with the use of medical devices. If you suspect a reportable adverse event associated with a NPWT system, you should follow the reporting procedure established by your facility. Prompt reporting of adverse events can help FDA to understand and communicate the risks associated with devices, and can help identify potential future problems with these products.

We also encourage you to report any medical device adverse events related to a NPWT system that do not meet the requirements for mandatory reporting. You can report these directly to the device manufacturer or to MedWatch, the FDA’s voluntary reporting program. This can be done online at http://www.fda.gov/medwatch/report.htm, by phone at 1-800-FDA-1088, by FAX at 1-800-FDA-0178; or by mailing FDA form 3500 (download from www.fda.gov/MedWatch/getforms.htm) to MedWatch, 5600 Fishers Lane, Rockville, MD 20857-9787.

Getting more information

If you have questions about this Notification, please contact FDA’s Office of Surveillance and Biometrics by e-mail at phann@fda.hhs.gov or by phone at 301-796-6640.

FDA Medical Device Public Health Notifications are available on the Internet. [[LINK]]You can also be notified through email each time a new Public Health Notification is added to our web page. To subscribe, visit: http://service.govdelivery.com/service/subscribe.html?code=USFDA_39.

Sincerely yours,

Jeffrey E. Shuren, MD, JD
Acting Director
Center for Devices and Radiological Health
Food and Drug Administration

• Take the Public Health Notification Readership Survey

*CDRH Preliminary Public Health Notifications are intended to quickly share device-related safety information with healthcare providers when the available information and our understanding of an issue are still evolving. We will revise them as new information merits and so encourage you to check this site for updates.

2. Click the Free Guidelines for treatment or prevention  link.

 3. Under title click PDF for full citation

Guidelines for the treatment of pressure ulcers (p 663-679)
JoAnne Whitney, Linda Phillips, Rummana Aslam, Adrian Barbul, Finn Gottrup, Lisa Gould, Martin C. Robson, George Rodeheaver, David Thomas, Nancy Stotts
Published Online: Jan 2 2007 12:00AM
DOI: 10.1111/j.1524-475X.2006.00175.x

Guidelines for the prevention of pressure ulcers (p 151-168)
Joyce K. Stechmiller, Linda Cowan, JoAnne D. Whitney, Linda Phillips, Rummana Aslam, Adrian Barbul, Finn Gottrup, Lisa Gould, Martin C. Robson, George Rodeheaver, David Thomas, Nancy Stotts
Published Online: Mar 4 2008 12:00AM
DOI: 10.1111/j.1524-475X.2008.00356.x

Guidelines for the treatment of venous ulcers (p 649-662)
Martin C. Robson, Diane M. Cooper, Rummana Aslam, Lisa J. Gould, Keith G. Harding, David J. Margolis, Diane E. Ochs, Thomas E. Serena, Robert J. Snyder, David L. Steed, David R. Thomas, Laurel Wiersma-Bryant
Published Online: Jan 2 2007 12:00AM
DOI: 10.1111/j.1524-475X.2006.00174.x

Guidelines for the prevention of venous ulcers (p 147-150)
Martin C. Robson, Diane M. Cooper, Rummana Aslam, Lisa J. Gould, Keith G. Harding, David J. Margolis, Diane E. Ochs, Thomas E. Serena, Robert J. Snyder, David L. Steed, David R. Thomas, Laurel Wiersema-Bryant
Published Online: Mar 4 2008 12:00AM
DOI: 10.1111/j.1524-475X.2008.00355.x

Guidelines for the treatment of arterial insufficiency ulcers (p 693-710)
Harriet W. Hopf, Cristiane Ueno, Rummana Aslam, Kevin Burnand, Caroline Fife, Lynne Grant, Allen Holloway, Mark D. Iafrati, Raj Mani, Bruce Misare, Noah Rosen, Dag Shapshak, J. Benjamin Slade Jr, Judith West, Adrian Barbul
Published Online: Jan 2 2007 12:00AM
DOI: 10.1111/j.1524-475X.2006.00177.x

Guidelines for the prevention of lower extremity arterial ulcers (p 175-188)
Harriet W. Hopf, Cristiane Ueno, Rummana Aslam, Alan Dardik, Caroline Fife, Lynne Grant, Allen Holloway, Mark D. Iafrati, Bruce Misare, Noah Rosen, Dag Shapshak, J. Benjamin Slade Jr., Judith West, Adrian Barbul
Published Online: Mar 4 2008 12:00AM
DOI: 10.1111/j.1524-475X.2008.00358.x

Guidelines for the treatment of diabetic ulcers (p 680-692)
David L. Steed, Christopher Attinger, Theodore Colaizzi, Mary Crossland, Michael Franz, Lawrence Harkless, Andrew Johnson, Hans Moosa, Martin Robson, Thomas Serena, Peter Sheehan, Aristidis Veves, Laurel Wiersma-Bryant
Published Online: Jan 2 2007 12:00AM
DOI: 10.1111/j.1524-475X.2006.00176.x

Mechanisms of Action – Debridement results from the necrotic tissue through proteolytic digestive enzymes and the physical action of the maggots mouth hooks on the tissue (this tears the tissue), allowing the digestive enzymes penetrate deeper into the necrotic tissue.

Clinical Indications – Maggot debridement therapy is indicated for infected, sloughy, or necrotic wounds, irrespective of etiology and including non-healing necrotic skin, pressure ulcers, neuropathic (diabetic) foot ulcers, chronic leg ulcers, malignant wounds or non-healing traumatic or post-operative wounds.

Contraindications for maggot therapy include: dry necrotic wounds, fistulae, wounds that connect with the abdominal cavity, wounds that bleed easily, wounds close to major blood vessels or nerves and any situations where the blood supply is insufficient to permit healing to take place.

Authors notes:

Read the package insert it is very informative

Don’t use harsh chemicals around the maggots (Kills them fast)

Stoma paste allowed to dry before introducing the maggots is a good adhesive

Advise the patient to call you ASAP should the dressing open.

If the maggots make it the full two days they will be much bigger. Open the dressing and they will escape pretty fast. Use an alcohol soaked 4×4 to swoop them up an smother them (place in double red bag). Irrigate the wound to flush out any strays.

Remember a straight face helps the patient cope with the thought of active maggots on their body.

     Two options remain Santyl (Healthpoint) and Biologicals (A nice way to say maggot therapy). Our clinic uses Monarch Labs for our maggots. To learn more go to the Monarch Lab web site at http://www.monarchlabs.com/  I will write more about both of these products in future posts.