3M Tegaderm Matrix Matrix Dressing. Case Studies

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1 Case Studies

2 Contents 2 Introduction: Treatment of a series of hard-to-heal chronic ulcers with Tegaderm TM Matrix Sylvie Hampton, MA BSc (Hons) DpSN RGN 3 Treatment of an intractable pressure ulcer with Tegaderm TM Matrix The care of Mrs Peters 5 Treatment with Tegaderm TM Matrix: A diabetic lady with a heel pressure ulcer The care of Mrs Cooper 7 Treatment of an intractable pressure ulcer with Tegaderm TM Matrix The care of Mrs Roper 9 Treatment of an intractable pressure ulcer with Tegaderm TM Matrix The care of Mrs Morris 11 Treatment with Tegaderm TM 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 Tegaderm TM Matrix The care of Mr Andrews 1

3 Treatment of a series of hard-to-heal chronic ulcers with Tegaderm TM 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 the effectiveness of Tegaderm TM Matrix and to validate the product claim to normalize the micro-environment of the wound 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 healing There is increasing evidence that matrix metalloproteinases (MMPs) and tissue inhibitor MMPs (TIMPs) play an important 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 the disturbed 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 Tegaderm TM Matrix dressing. Tegaderm TM 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 for the production of MMPs and thereby redresses the MMP imbalance in chronic wounds, allowing them to heal. Decreased levels of MMP-2 and MMP-9 are seen in tissue fibroblasts after a period of Tegaderm TM Matrix treatment; these levels decrease even more as the wound heals. * 3M Tegaderm Matrix, formerly known as DerMax or Epimax 2

4 Treatment of an intractable pressure ulcer with Tegaderm TM 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 her immobility 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 Tegaderm TM Matrix was introduced on October 28. This dressing combination remained the same until the wound healed (December 17). During the trial the dressing change frequency gradually reduced from daily dressing to twice weekly. Using this particular foam adhesive sacral dressing, size 22 cm x 22 cm (8 7 /8" x 8 7 /8"), at cost of ($23.10 Cdn), on a daily dressing change basis, led to a dressing materials cost of ($ 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 s wound was not progressing. In order to stimulate wound healing, the novel MMP-balancing wound dressing Tegaderm TM Matrix was selected as it blocks MMPs from entering the wound environment. Once the wound was dressed with Tegaderm TM Matrix, the wound rapidly moved from indolent to a healing state and dressing changes were reduced to two changes per week, at a cost saving of ($ Cdn) per month. The overall cost of Tegaderm TM Matrix for the complete 50-day treatment was approximately ($ Cdn) plus the overall cost of the foam dressing at ($315 Cdn) giving a total cost of ($ Cdn). Therefore, the use of Tegaderm TM Matrix during the 50 days provided a material cost saving of ($ Cdn) for this patient. Currency conversion based on exchange rate of

Figure 1. October 28: Wound measures 5.5 cm x 3.3 cm.

Matrix Figure 3. November 12: Wound now measures 0.9 cm

5 Figure 1. October 28: Wound measures 5.5 cm x 3.3 cm. The wound is clean but not healing Figure 2. November 4: The wound has greatly reduced in size. The only treatment to have been changed is 3M TM Tegaderm TM Matrix 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 completely healed a period of seven weeks 4

6 Treatment with Tegaderm TM 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 to pressure 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 ($16.80 Cdn) per dressing) were being changed on alternate days over several months at a cost of ($ Cdn) per month. Tegaderm TM 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 the study, the wound completely healed. The overall cost of treatment with Tegaderm TM Matrix was ($357 Cdn) showing a cost saving of ($1,092 Cdn) over the previous dressing regimen used to treat this wound. *The Waterlow score is a pressure ulcer risk assessment/prevention policy tool used in the U.K. Currency conversion based on exchange rate of

Figure 1. July 18: Wound measures 5.5 cm x 3.3 cm.

October 10: There is some granulation present although there is

9 cm, a reduction in surface area of 15.

7 Figure 1. July 18: Wound measures 5.5 cm x 3.3 cm. There is some necrosis present Figure 2. October 10: There is some granulation present although there is some slough 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 following continuing treatment with 3M TM Tegaderm TM Matrix, outside the study period 6

8 Treatment of an intractable pressure ulcer with Tegaderm TM Matrix The care of Mrs Roper Mrs Roper (name changed) a 72-year-old lady with a pressure ulcer was admitted to a nursing home from hospital, in May Mrs Roper had severe Parkinson s disease, but was fully compus-mentus and bright and knew exactly how to direct her care. With a little help she was mobile and directed the health care professionals in how 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 ($3.57 Cdn) per dressing. The dressing was changed daily at a material cost of 51 ($ Cdn) per month. The wound appeared to have clean granulating tissue in the base which normally indicates a healing wound. Nevertheless, the wound was not progressing and had been static for several months. Tegaderm TM Matrix was commenced on August 12. A secondary dressing was required to hold the Tegaderm TM Matrix in place, and an adhesive bordered foam was the selected dressing at a cost of 3.40 ($7.14 Cdn) per dressing. Dressing changes were gradually reduced from daily to weekly and by October 20 (69 days) the wound healed at a material cost of ($ Cdn). Although the material cost of this treatment was higher than the 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. Currency conversion based on exchange rate of

August 18: Six days after commencement of therapy, the wound had changed

3. August 24: Six days later the wound no longer has the skin and has the

The surrounding skin is slightly macerated but Mrs Roper did not complain

September 2: Twenty days after commencement the wound is still red around

9 Figure 1. August 4: Eight days before start of 3M TM Tegaderm TM Matrix treatment. The wound measured 5 cm x 4 cm. Wound bed is clean but non-healing Figure 2. August 18: Six days after commencement of therapy, the wound had changed in appearance and had a strange skin covering the base of the wound Figure 3. August 24: Six days later the wound no longer has the skin and has the appearance of potentially over granulating. The surrounding skin is slightly macerated but Mrs Roper did not complain of discomfort Figure 4. September 2: Twenty days after commencement the 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 is significantly reduced in size. A reduction in wound surface area of 7.8 sq cms 8

10 Treatment of an intractable pressure ulcer with Tegaderm TM Matrix The care of Mrs Morris Mrs Morris, (name changed) an 81-year-old lady with Parkinson s disease was admitted to a nursing home on July 25 with an established EPUAP grade or stage IV pressure ulcer. She had a Waterlow* score of 25 which placed her at very high risk of further tissue damage. The score reduced to 19 during the period of the case study, although this is still high risk. Previous treatment of her wound included use of a range of dressing combinations including hydrofibre ribbon covered by a hydrocolloid dressing; Metrotop gel and a hydrogel sheet. Use of a hydrofibre dressing covered with an adhesive foam sacral dressing was the most recent treatment. This was changed every three days at a cost of ($ Cdn) per month. Mrs Morris always insisted on sitting out in a chair on a static cushion. She would nap on her bed following lunch and then sit out again. The only change to her care was the introduction of Tegaderm TM 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 were gradually reduced to two changes per week at a cost of ($ Cdn) per month representing a saving of ($ Cdn). *The Waterlow score is a pressure ulcer risk assessment/prevention policy tool used in the U.K. Currency conversion based on exchange rate of

Photographs were discontinued on October 31 after a period of ten-and-a-half weeks which was outside the

However, the 3M TM Tegaderm TM Matrix was continued as the wound had made excellent progress and it

August 4: Wound before first application of Tegaderm TM Matrix Figure 2. August 18: Wound measures 5.

The base exposes bone (grade or stage IV) and there are large amounts of slough and necrotic tissue with

August 24: The wound contains less slough and the odour has reduced considerably Figure 4.

11 Photographs were discontinued on October 31 after a period of ten-and-a-half weeks which was outside the length of the study. However, the 3M TM Tegaderm TM Matrix was continued as the wound had made excellent progress and it would have been unethical to discontinue treatment. The wound went on to fully heal. Figure 1. August 4: Wound before first application of Tegaderm TM Matrix Figure 2. August 18: Wound measures 5.0 cm x 3.3 cm. The base exposes bone (grade or stage IV) and there are large amounts of slough and necrotic tissue with a powerful malodour Figure 3. August 24: The wound contains less slough and the odour has reduced considerably Figure 4. September 2: Wound measures 3.0 cm x 3.9 cm. A total reduction in wound size of 4.8 sq cms in one month Figure 5. October 31, three months: Use of Tegaderm TM Matrix continues and the wound continues to improve following the trial period. It is now entirely free from slough, very little malodour and there is granulation clearly present. The wound bed no longer exposes bone. 10

12 Treatment with Tegaderm TM Matrix: Treatment of a pressure ulcer over the elbow The care of Mrs Ashford Mrs Ashford (name changed) was a 75-year-old lady who lived in a nursing home. She was nursed on an air mattress when 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 had been 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 dressing was changed twice weekly the cost of treatment was low (approximately ($ Cdn) per month). Tegaderm TM 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 in place 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 ($ Cdn) per month resulted from the use of Tegaderm TM Matrix after one month s treatment. Currency conversion based on exchange rate of

Figure 1. July 15: Wound measured 2.8 cm x 2.

$July 28: Within two weeks, the wound is a fraction of$ the original size Figure 3.

13 Figure 1. July 15: Wound measured 2.8 cm x 2.2 cm with necrotic tissue, and is deep (grade or stage IV) Figure 2. July 28: Within two weeks, the wound is a fraction of the original size Figure 3. August 4: The wound is now on the point of closure with little to no exudate Figure 4. August 12: The wound cannot be measured and can be considered closed. A reduction in surface area of 5.6 sq cms. Healing has occurred in four weeks 12

14 Treatment of a grade or stage II pressure ulcer with Tegaderm TM Matrix The care of Mr Andrews Mr Andrews (name changed) was a 62-year-old gentleman with diabetes and several pathologies, including multiple sites of cancer that placed him at very high risk of pressure damage. He was admitted into a nursing home from hospital 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. Tegaderm TM Matrix was applied on May 9 with a simple adhesive foam as a secondary dressing. The wound healed within six 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. 13

May 31: The wound has almost reached full

15 Figure 1. May 9: Wound measures 2.6 cm x 3 cm and was initially classified as a grade or stage II ulcer Figure 2. May 19: 10 days later the wound is much improved with significant granulation Figure 3. May 31: The wound has almost reached full closure Figure 4. June 17: Six weeks after commencement of 3M TM Tegaderm TM Matrix the wound has closed 14

Supports faster healing in chronic wounds 1 Ordering information Normalizes the wound micro-environment 2-4 Regulates MMPs (matrix metalloproteinases) 5 Facilitates re-epithelialization 2 Catalogue

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.

16 Supports faster healing in chronic wounds 1 Ordering information Normalizes the wound micro-environment 2-4 Regulates MMPs (matrix metalloproteinases) 5 Facilitates re-epithelialization 2 Catalogue No. Size Dressings/Box Boxes/Case in x 2 3 /8 in cm x 6 cm /8 in x 4 in cm x 10 cm 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 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 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; 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 PHI: Polyhydrated ionogens 3M Canada P.O. Box 5757 London, ON N6A 4T1 Canada 3M Medica D Neuss Germany M and Tegaderm are trademarks of 3M. Metrotop is a trademark of Mölnlycke. Used under license in Canada. 2007, 3M. All rights reserved CP e

3M Tegaderm Matrix Matrix Dressing. Matrix. Your questions answered

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