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Case Studies 3M Tegaderm Matrix Matrix Dressing

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CaseStudies

3M™ Tegaderm™ MatrixMatrix Dressing

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Contents

2 Introduction: Treatment of a series of hard-to-heal chronic ulcers with TegadermTM Matrix – Sylvie Hampton, MA BSc (Hons) DpSN RGN

3 Treatment of an intractable pressure ulcer with TegadermTM Matrix – The care of Mrs Peters

5 Treatment with TegadermTM Matrix: A diabetic lady with a heel pressure ulcer – The care of Mrs Cooper

7 Treatment of an intractable pressure ulcer with TegadermTM Matrix – The care of Mrs Roper

9 Treatment of an intractable pressure ulcer with TegadermTM Matrix – The care of Mrs Morris

11 Treatment with TegadermTM Matrix: Treatment of a pressure ulcer over the elbow – The care of Mrs Ashford

13 Treatment of a grade or stage II pressure ulcer with TegadermTM Matrix – The care of Mr Andrews

3M™ Tegaderm™ MatrixMatrix Dressing

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Treatment of a series of hard-to-heal chronic ulcers with TegadermTM Matrix*

Sylvie Hampton, MA BSc (Hons) DpSN RGN

Healing in many types of ‘real life’ wounds cannot be shown through randomized controlled trials, as the inclusion/exclusion criteria are so strict that it excludes the wound types that are frequently difficult to heal in the community. A prospective clinical study was undertaken, including a series of case studies in non-healing, commonly-found chronic wounds (present for more than three months). The aim of this study was to evaluate theeffectiveness of TegadermTM Matrix and to validate the product claim to normalize the micro-environment of thewound and aid wound healing. This paper describes several examples of case studies from this series. Firstly, some background on the micro-environment of hard-to-heal wounds.

Matrix metalloproteinases and wound healingThere is increasing evidence that matrix metalloproteinases (MMPs) and tissue inhibitor MMPs (TIMPs) play animportant role in the complex and orchestrated events that lead to wound healing. An imbalance of MMPs in the wound micro-environment has been associated with poor healing leading to development of chronic wounds. Several studies of wound fluid have shown high levels of MMPs and low levels of TIMPs in chronic ulcers. In contrast, acute surgical wounds with balanced MMP levels show low MMP-2 and MMP-9, high TIMPs levels and heal expeditiously. Therefore, a therapeutic agent that redresses the imbalance of MMPs could restore thedisturbed homeostasis in hard-to-heal chronic wounds which then leads to a re-initiation of wound healing. This concept has led to the discovery and development of TegadermTM Matrix dressing.

TegadermTM Matrix consists of an acetate carrier impregnated with a mixture of metal ions (including zinc, calcium, potassium and rubidium) in an acid-buffered hydrophilic ointment. This formula acts by reducing the gene expression forthe production of MMPs and thereby redresses the MMP imbalance in chronic wounds, allowing them to heal. Decreasedlevels of MMP-2 and MMP-9 are seen in tissue fibroblasts after a period of TegadermTM Matrix treatment; these levelsdecrease even more as the wound heals.

3M™ Tegaderm™ MatrixMatrix Dressing

* 3M™ Tegaderm™ Matrix, formerly known as DerMax® or Epimax®

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Treatment of an intractable pressure ulcer with TegadermTM Matrix

The care of Mrs Peters Mrs Peters (name changed) is an 83-year-old lady who lives with her husband at home but had become increasingly weak and was taken to hospital for investigations. Nothing was identified during hospitalization, and it was thought that the weakness was age-related. She could no longer cope at home and was transferred to a nursing home. Due to herimmobility and frailty, in the day she sat in a chair, with a gel cushion in situ and had an air mattress on the bed during nighttime. Sacral pressure damage was caused by her immobility prior to the use of air mattress and cushion.However, even with the use of these pressure-relieving aids, the wound, which was clean and without slough, was not healing (Figure 1).

Previously a foam adhesive, sacral-shaped dressing was used. It was changed on a daily basis and use of this product, as a secondary dressing, continued when TegadermTM Matrix was introduced on October 28. This dressing combination remained the same until the wound healed (December 17). During the trial the dressing change frequencygradually reduced from daily dressing to twice weekly. Using this particular foam adhesive sacral dressing, size 22 cm x22 cm (87/8" x 87/8"), at cost of £11.00 ($23.10 Cdn), on a daily dressing change basis, led to a dressing materials cost of£309.00 ($648.90 Cdn) per month for care of this wound.

Despite best practice regarding pressure relief being implemented and a modern wound dressing being used, Mrs Peter’swound was not progressing. In order to stimulate wound healing, the novel MMP-balancing wound dressingTegadermTM Matrix was selected as it blocks MMPs from entering the wound environment. Once the wound wasdressed with TegadermTM Matrix, the wound rapidly moved from indolent to a healing state and dressing changes werereduced to two changes per week, at a cost saving of £220.64 ($463.34 Cdn) per month.

The overall cost of TegadermTM Matrix for the complete 50-day treatment was approximately £143.00 ($300.30 Cdn)plus the overall cost of the foam dressing at £150.00 ($315 Cdn) giving a total cost of £293.00 ($615.30 Cdn).Therefore, the use of TegadermTM Matrix during the 50 days provided a material cost saving of £257.00 ($539.70 Cdn)for this patient.

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Currency conversion based on exchange rate of 2.1.

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Figure 1.

October 28: Wound measures 5.5 cm x 3.3 cm. The wound is clean but not healing

Figure 3.

November 12: Wound now measures 0.9 cm x 2.9 cm. A total surface area reduction of 15.9 sq cms

By December 29 this wound was completelyhealed – a period of seven weeks

Figure 2.

November 4: The wound has greatly reduced insize. The only treatment to have been changedis 3MTM TegadermTM Matrix

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Treatment with TegadermTM Matrix: A diabetic patient with a heel pressure ulcer

The care of Mrs Cooper Mrs Cooper (name changed) is a 79-year-old diabetic lady who had previously had an amputated left leg due topressure damage over the heel. She had a Waterlow* score of 20 which placed her at very high risk of development of further pressure ulcers. There was now a pressure ulcer on the right heel that had been present for 8.5 months.Her previous treatment included an electrical dressing and then a hydrogel sheet dressing which had greatly improved the wound and it had almost reached closure. At this point there was a severe breakdown of the wound (Figure 1) and dressings (hydrofibre – cost £7.70 ($16.17 Cdn) per dressing and foam – cost £8.00($16.80 Cdn) per dressing) were being changed on alternate days over several months at a cost of £235.00($493.50 Cdn) per month.

TegadermTM Matrix was first applied on July 18. The secondary dressing used was gauze and this was held in place by orthopaedic wool and a simple retention bandage. Healing was slow, possibly due to the diabetic pathology. Within a short period of time dressing changes were reduced to twice weekly for eight weeks and then reduced to once per week until October 18 (92 days) by which time the wound had almost reached full closure. Following thestudy, the wound completely healed. The overall cost of treatment with TegadermTM Matrix was £170.00 ($357 Cdn)showing a cost saving of £520.00 ($1,092 Cdn) over the previous dressing regimen used to treat this wound.

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*The Waterlow score is a pressure ulcer risk assessment/prevention policy tool used in the U.K.Currency conversion based on exchange rate of 2.1.

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Figure 1.

July 18: Wound measures 5.5 cm x 3.3 cm. There is some necrosis present

Figure 3.

October 18: The wound measures 0.9 cm x 2.9 cm,a reduction in surface area of 15.9 sq cms

This wound went on to full healing followingcontinuing treatment with 3MTM TegadermTM

Matrix, outside the study period

Figure 2.

October 10: There is some granulation presentalthough there is some slough

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Treatment of an intractable pressure ulcer with TegadermTM Matrix

The care of Mrs RoperMrs Roper (name changed) a 72-year-old lady with a pressure ulcer was admitted to a nursing home from hospital, in May 2005. Mrs Roper had severe Parkinson’s disease, but was fully compus-mentus and bright andknew exactly how to direct her care. With a little help she was mobile and directed the health care professionals inhow she wanted her wound photographed at each visit. Sometimes when standing, sometimes when lying down.Previous dressings used were a simple foam at a cost of £1.70 ($3.57 Cdn) per dressing. The dressing waschanged daily at a material cost of £51 ($107.10 Cdn) per month. The wound appeared to have clean granulatingtissue in the base which normally indicates a healing wound. Nevertheless, the wound was not progressing andhad been static for several months.

TegadermTM Matrix was commenced on August 12. A secondary dressing was required to hold the TegadermTM

Matrix in place, and an adhesive bordered foam was the selected dressing at a cost of £3.40 ($7.14 Cdn) perdressing. Dressing changes were gradually reduced from daily to weekly and by October 20 (69 days) the woundhealed at a material cost of £321.00 ($674.10 Cdn). Although the material cost of this treatment was higher thanthe initial dressing costs, cost-effectiveness was still fully demonstrated as this previously non-healing wound went on to heal without complications and without any pain in less than 10 weeks. Very successful health economic and patient outcomes.

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Figure 1.

August 4: Eight days before start of 3MTM TegadermTM

Matrix treatment. The wound measured 5 cm x 4 cm.Wound bed is clean but non-healing

Figure 3.

August 24: Six days later the wound no longer has the‘skin’ and has the appearance of potentially overgranulating. The surrounding skin is slightly maceratedbut Mrs Roper did not complain of discomfort

Figure 4.

September 2: Twenty days after commencementthe wound is still red around the peri wound area, but there is now closure of the wound edges

Figure 5.

September 30: At seven weeks, as the wound heals,the exudate reduces and the redness dissipates

Figure 6.

October 18: After 10 weeks the wound issignificantly reduced in size. A reduction inwound surface area of 7.8 sq cms

Figure 2.

August 18: Six days after commencement of therapy,the wound had changed in appearance and had astrange ‘skin’ covering the base of the wound

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Treatment of an intractable pressure ulcer with TegadermTM Matrix

The care of Mrs MorrisMrs Morris, (name changed) an 81-year-old lady with Parkinson’s disease was admitted to a nursing home onJuly 25 with an established EPUAP grade or stage IV pressure ulcer. She had a Waterlow* score of 25 which placedher at very high risk of further tissue damage. The score reduced to 19 during the period of the case study, althoughthis is still high risk.

Previous treatment of her wound included use of a range of dressing combinations including hydrofibre ribbon coveredby a hydrocolloid dressing; Metrotop™ gel and a hydrogel sheet. Use of a hydrofibre dressing covered with an adhesivefoam sacral dressing was the most recent treatment. This was changed every three days at a cost of £243.00($510.30 Cdn) per month. Mrs Morris always insisted on sitting out in a chair on a static cushion. She would napon her bed following lunch and then sit out again.

The only change to her care was the introduction of TegadermTM Matrix to replace the hydrofibre dressing, which was applied initially on August 4. A simple adhesive foam was used as a secondary dressing. Dressing changes weregradually reduced to two changes per week at a cost of £199.00 ($417.90 Cdn) per month representing a saving of £144.00 ($302.40 Cdn).

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*The Waterlow score is a pressure ulcer risk assessment/prevention policy tool used in the U.K.Currency conversion based on exchange rate of 2.1.

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Figure 1.

August 4: Wound before first application ofTegadermTM Matrix

Photographs were discontinued on October 31 – after a period of ten-and-a-half weeks which was outside thelength of the study. However, the 3MTM TegadermTM Matrix was continued as the wound had made excellentprogress and it would have been unethical to discontinue treatment. The wound went on to fully heal.

Figure 3.

August 24: The wound contains less slough andthe odour has reduced considerably

Figure 5.

October 31, three months: Use of TegadermTM

Matrix continues and the wound continues to improve following the trial period. It is nowentirely free from slough, very little malodourand there is granulation clearly present. The wound bed no longer exposes bone.

Figure 4.

September 2: Wound measures 3.0 cm x 3.9 cm. A total reduction in wound size of 4.8 sq cms inone month

Figure 2.

August 18: Wound measures 5.0 cm x 3.3 cm.The base exposes bone (grade or stage IV) andthere are large amounts of slough and necrotictissue with a powerful malodour

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Treatment with TegadermTM Matrix: Treatment of a pressureulcer over the elbow

The care of Mrs AshfordMrs Ashford (name changed) was a 75-year-old lady who lived in a nursing home. She was nursed on an air mattresswhen in bed but she developed a very nasty pressure ulcer on her elbow which was grade or stage IV (down to bone).It was thought that she had developed the sore from the arm of her chair when sitting out during the day. This hadbeen rectified a month previously by padding her elbow. She was placed on bed rest but the ulcer did not improve.After three months the wound was indolent and required stimulating to initiate the healing process.

The previous dressing used was a hydrofibre dressing which was held in place by retention bandages. As the dressingwas changed twice weekly the cost of treatment was low (approximately £77.00 ($161.70 Cdn) per month).

TegadermTM Matrix was first applied on July 15. It was covered with a simple foam dressing to absorb fluid and provide a moist wound healing environment. Orthopaedic wool and a simple retention bandage held the dressings inplace and padded the elbow.

The progress of the wound was remarkable, healing within one month from a large grade or stage IV ulcer to complete closure. Since a healed wound bears no cost of treatment, a saving of £77 ($161.70 Cdn) per month resultedfrom the use of TegadermTM Matrix after one month’s treatment.

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Currency conversion based on exchange rate of 2.1.

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Figure 1.

July 15: Wound measured 2.8 cm x 2.2 cm withnecrotic tissue, and is deep (grade or stage IV)

Figure 3.

August 4: The wound is now on the point ofclosure with little to no exudate

Figure 4.

August 12: The wound cannot be measuredand can be considered closed. A reduction insurface area of 5.6 sq cms. Healing hasoccurred in four weeks

Figure 2.

July 28: Within two weeks, the wound is afraction of the original size

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Treatment of a grade or stage II pressure ulcer withTegadermTM Matrix

The care of Mr AndrewsMr Andrews (name changed) was a 62-year-old gentleman with diabetes and several pathologies, including multiplesites of cancer that placed him at very high risk of pressure damage. He was admitted into a nursing home fromhospital with a pressure ulcer over his left hip and sacrum. The hip wound was extremely sore and, even though he was placed on an air mattress, was not healing.

TegadermTM Matrix was applied on May 9 with a simple adhesive foam as a secondary dressing. The wound healed withinsix weeks and without problems. Rapid healing was achieved despite his multiple pathology including throat cancer,which meant nutrition was poor. Unfortunately, shortly after his wound healed, Mr Andrews died.

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Figure 1.

May 9: Wound measures 2.6 cm x 3 cm and wasinitially classified as a grade or stage II ulcer

Figure 3.

May 31: The wound has almost reached full closure

Figure 4.

June 17: Six weeks after commencement of 3MTM TegadermTM Matrix the wound has closed

Figure 2.

May 19: 10 days later the wound is muchimproved with significant granulation

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References:1. Hampton S, Young S, Kerr A, King L. (2006). An observational study of the use of a polyhydrated ionogen impregnated dressing (DerMax) in the treatment of wounds. Poster presentation, EWMA, Prague,

Czech Republic. May 2006.2. Hoekstra M, Pirayesh A. (2003). Poly Hydrated Ionogens regulate Matrix Metalloproteinases Expression and Reactive Oxygen Species in Recalcitrant Wounds. European Tissue Repair Society Congress, September 2003.3. Körber A, Freise J, Rietkötter J, Grabbe S, Dissemond J. (2006). Erfolgreiche Behandlung therapierefraktärer chronischer Wunden mit DerMax (Successful treatment of therapy-refractory chronic wounds with

Tegaderm Matrix). Zeitschrift fur Wundheiling 6; 310-314.4. van den Berg AJJ, Halkes SBA, Quarles van Ufford HC, Hoekstra MJ, Beukelman CJ. (2003). A novel formulation of metal ions and citric acid reduces reactive oxygen species in vitro. J Wound Care 12(10).5. Monroe S, Sampson EM, Popp MP, Lobman R, Schultz GS. (2005). Effect of Polyhydrated Ionogens (PHI) on Viability and Matrix Metalloproteinase Levels in Cultures of Normal and Diabetic Human Dermal Fibroblast.

Poster Presentation WHS. Chicago. May 2005.

PHI: Polyhydrated ionogens

• Normalizes the wound micro-environment2-4

• Regulates MMPs (matrix metalloproteinases)5

• Facilitates re-epithelialization2

Ordering information

3M™ Tegaderm™ MatrixMatrix Dressing

in chronic wounds1

Supports faster healing

Catalogue No. Size Dressings/Box Boxes/Case

90900 2 in x 2 3/8 in 10 85 cm x 6 cm

90901 3 1/8 in x 4 in 5 88 cm x 10 cm

3M Canada 3M MedicaP.O. Box 5757 D-41453 NeussLondon, ON N6A 4T1 GermanyCanada

1 800 364-3577

www.3M.com/ca/healthcare

3M and Tegaderm are trademarks of 3M. Metrotop is a trademark of Mölnlycke.

Used under license in Canada. © 2010, 3M. All rights reserved. 1006-01931E