OPT ONS IN PRACTCE FEATURE EDITOR: Maureen Hanlon, RN, MN, CWOCN
Ptions in Practice presents different m a n a g e m e n t approaches to the same clinical situation. You are invited to submit a brief case description, including the specialty nursing care provided, and several glossy, color photographs of the clinical situation. The case material will then be sent to another wound, ostomy, or continence care nurse, who will also address m a n a g e m e n t concerns. Alternative solutions to difficult wound, ostomy, or incontinence clinical situations will be published.
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TREATMENT OPTIONS FOR HEALING OF A FULLTHICKNESS WOUND AFTER FAILED ABDOMINOPLASTY Case History
Patrlcla Gill, MSN, CNN, CWCN, is Clinical Nurse Specialist/Clinlcal Manager, Comprehensive Wound Management Program, Phoenix Reglonal Medical Center, Phoenlx, Arizona. Shella Griffin, MSN, RN, CWOCN, CS, Is ETNurse, ETNursing Department, Harris Methodist Fort Worth Hospital, Fort Worth, Texas. Patrlcla Gill has no financial interest In or financial Involvement with Ortho McNeil Pharmaceutlcal, the manufacturer of becaplermln gel (Regranex). Reprint requests: Patricla Gill, MSN, CNN, CWCN, Comprehenslve Wound Management Program, Phoenlx Regional Medlcal Center, 1947 East Thomas Rd, Phoenix, AZ 85016; e-mall: pmglll l 112@aoLcom Copyright @ 2000 by the Wound, Ostomy and Continence Nurses Society. J WOCN 2000;27:42-5. 1071-5754/2000/$12.00 + 0
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A 35-year-old woman who delivered a healthy baby was unhappy with her resulting pendulous abdomen that did not improve with postpartum exercise. Therefore, she underwent elective abdominoplasty surgery 8 months after childbirth. Abdominoplasty and hip-lower flank suction lipectomy were performed by a plastic surgeon, resulting in an incision that measured 22.8 cm in length. One week later, flap failure developed as a result of ischemia. No infection or odor was present. The patient was instructed by her surgeon to clean the wound with hydrogen peroxide and to apply dry dressings. Approximately 1 to 2 weeks following surgery, she received 3 treatments of hyperbaric oxygen at 2.4 atmospheres for 90 minutes with a 10-minute air break. The wound remained closed, but it was black and necrotic. The patient sought additional treatment from the surgeon, who performed complete sharp debridement in the office on a weekly basis, and the patient was instructed to apply moist normal saline solution dressings during the interim. Because the patient was a physical therapist and was familiar with the management of injuries and wounds, she performed daily self-debridement of the wound. This self-debridement included the use of "pickups" to remove loose yel-
low slough and sharp debridement to separate black necrotic skin from the wound edges. One month later the patient came to a Wound Healing Center with a fullthickness wound that extended to the fascia and measured 5.3 cm x 18.1 cm x 2.7 cm (length x width x depth) (Figure 1). The wound bed was filled with granulation tissue but also contained areas of slough and fibrin, as well as a small amount of necrotic tissue at its edges. Patricia Gill, MSN, CNN, CWCN: Sharp debridement was performed at the patient's initial visit to the Wound Healing Center and weekly thereafter. Treatment with becaplermin gel (recombinant human platelet-derived growth factor-BB [rh-PDGF-BB], [Regranex gel 0.01%], Ortho McNeil Pharmaceuticals, Raritan, NJ) was also initiated. This gel consists of rh-PDGF-BB formulated in a preserved sodium carboxymethylcellulose-based gel (100 Bg/g). Endogenous growth factors, such as platelet-derived growth factor, are involved in all phases of normal wound healing, and evidence also exists that levels of these growth factors are reduced in chronic nonhealing wounds3 Therefore, topical application of exogenous growth factors may enhance healing of difficult wounds. In controlled clinical trials, becaplermin gel has been shown to increase the incidence of healing and decrease the time required to achieve healing in patients with lower extremity diabetic neuropathic ulcers. 2-4 Currently, it is the only recombinant human growth factor approved by the US Food and Drug Administration (FDA) for this indication. This combination of becaplermin gel and regular debridement was selected because the patient was in a controlled environment and rapid wound closure was deemed imperative. Becaplermin gel was applied once daily and covered with moist saline solution dressings, which were changed twice daily. Within 2 weeks, the wound showed marked healing (3.4 cm x 18 cm x 1.6 cm). Further improvement was noted 2 weeks later (Figure 2), and the wound was almost completely healed by the sixth week (1 cm x 11.8 cm x 0.4 cm) (Figure 3). Topical treatment was continued for a total of 8 weeks, at which time the wound was considered closed. Follow-up exami-
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nation approximately 3 months after initiation of treatment revealed a healed wound (Figure 4). This was the first time we had used becaplermin gel for a large w o u n d of this type. Only 3 tubes of the gel were used during the duration of treatment, because we applied less gel than the volume indicated in the manufacturer's recommended dosing guidelines. The presence of a large full-thickness chronic wound following abdominoplasty presented multiple physical and personal challenges to this patient. Although she was a new mother, she had difficulty holding and caring for her infant. She was unable to return to the physically active lifestyle that she had enjoyed prior to the abdominoplasty, which included swimming, hiking, camping, and scuba diving. Even choosing clothes to wear was a challenge, given the need to guard the wound from trauma and to perform a regimen of w o u n d care several times daily. She was unable to return to work because of the large volume of exudate, the need for frequent dressing changes, and the resulting physical limitations, including the inability to lift patients and perform other activities required of a physical therapist. Successful healing of this chronic w o u n d allowed her to return to the lifestyle, income level, and quality of life that she had enjoyed prior to her surgery. Sheila Griffin, MSN, RN, CWOCN, CS= As a WOC nurse practicing in acute and ambulatory settings, I have provided w o u n d care services for a number of young, otherwise healthy patients in w h o m large chronic w o u n d s developed following elective surgery or trauma. For such patients, the goal of treatment is to devise a w o u n d care plan that promotes rapid healing and allows them to return to their active lifestyle as rapidly as possible. In some situations, financial constraints limit the type of w o u n d care products used, while other scenarios allow consideration of even the most expensive options. The treatment options of the patient in this case do not appear to have been limited by cost considerations; however, the possibility of financial constraints exists, given the fact that this was originally a plastic surgery procedure, for which limited insurance reimbursement is sometimes provided. The patient presented in this case had several characteristics that favored rapid and effective w o u n d healing. She was young and educated as a physical thera-
Gill and Griffin 43
Figure 1. Abdominal wound before application of becaplermin gel (5.3 cm x 18.1 cm x 2.7 cm deep).
Figure 2. Significant healing of abdomlnal w o u n d after 4 week.s,of treatment with becaplermln gel (2.1 c m x 14.6 c m x I c m deep).
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Figure 3. Abdominal wound almost completely healed following 6 weeks of becaplermin gel therapy.
Figure 4. Healed abdominal wound approximately 3 months after initiation of becaplermin gel treatment.
Table 1. Cost c o m p a r i s o n per dressing c h a n g e for a 18 x 5 c m w o u n d : Kollagen Medifil Particles vs b e c a p l e r m i n gel using manufacturerr e c o m m e n d e d dosages
Kollagen Medifll Particles
Becaplermin gel
Approximately $21 per 10 mL vial Amount used per dressing: 2.5 mL = $5.25 (product literature chart) Variables: • Amount of particles used depends on drainage; heavy drainage = more particles; moderate drainage = fewer particles • Dressing change is once daily with heavy drainage, every other day dressings with moderate to light drainage
Approximately $350 per 15 g tube Amount used per dressing: 5.6 g = $130 Formula to calculate length of gel in cm to be applied daily: • Wound length x width divided by 4 • Uses 0.25 g gel per square cm ulcer surface Note: Manufacturer recommends second dressing change per day with moist dressing (without becaplermin gel)
pist. These attributes enabled her to provide optimal self-care, including not only dressing changes but also removal of nonviable tissue. An additional area to consider would be a nutrition consult or screening to address the patient's protein, calorie, and micronutrient intake. It cannot be assumed that because of her professional education she would address these areas. It could also be hypothesized that the stress of being a new mother and the effects of her surgery as well as body image issues may have had a negative impact on her dietary habits. Although treatment with sharp wound debridement and becaplermin gel was successful for this patient, other less expensive options also should be considered. Furthermore, it is important to note that becaplermin gel has not received FDA approval for clinical applications other than lower extremity diabetic ulcers. The product literature for this product indicates that of the 4 clinical trials submitted for the FDA approval process, the second largest sample group did not show a significant difference between treatment with becaplermin gel and good ulcer care alone. It could also be considered relevant that in these clinical studies, wound healing differences were most pronounced after approximately 10 weeks of treatment, whereas this patient underwent 8 weeks of therapy. 5 These statements are not intended to diminish the efficacy of becaplermin gel but to note the importance of reviewing the clinical trial information provided in product literature when each practitioner evaluates its use. A w o u n d care option that could be of equal efficacy or more efficacious for this type of w o u n d is lyophilized collagen, bovine type I (Kollagen, Biocore Medical Technologies, Inc, Topeka, Kan). This product is available in several vehicles including particles, gel, pads, and dressings. N u m e r o u s research studies have substantiated the effectiveness of this form of collagen. 5-9 The granulation tissue produced is described as high quality, and some of the most dramatic healing rates have been noted with wounds similar to that of the patient in this case. However, this product is not classified as a pharmaceutical, thus placing it ha a different category with regard to the rigors of receiving approval for sale. Collagen offers a lower cost option and still provides components designed to reverse the chronic w o u n d environment. A sample cost comparison
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of the two product options is listed in Table 1. Reimbursement for either product by Medicare payers and private insurance continues to vary and should be investigated before initiating either option. An alternative treatment would begin with thorough but nontraumatic wound cleansing. Use of sterile saline solution in a pressurized can provides the appropriate pounds per square inch (PSI) for wound irrigation and convenience to the patient (Wound Wash Saline, Blairex Laboratories, lnc, Columbus, Ind). Use of specialized wound dressings such as collagen or growth factors are most effective when applied to viable tissue; therefore, debridement of the wound, whether sharp, enzymatic, or autolytic, should occur until approximately 50% of the w o u n d base comprises viable tissue. Given the profession of the patient, sharp wound debridement was selected as the method of choice. Alternate methods of debridement in this situation might include gel-saturated dressings (Carragauze, Carrington Laboratories, Inc, Irving, Tex) for autolysis or an enzymatic debriding agent such as papain urea (Accuzyme, HealthPoint Medical, Fort Worth, Tex). The physician or WOC nurse could also perform sharp wound debridement as needed during clinic visits. Once a viable wound base of at least 50% healthy granulation tissue is exposed, application of the bovine collagen can begin. Dressing change frequency depends on the amount of drainage. Because the amount of this patient's wound exudate was described as large, I would begin with daily changes and decrease frequency as exudate diminishes. Product literature recommends use of the particle (Medifil) configuration with moderate to large amounts of drainage. A sample dressing change procedure is listed in Table 2. Use of a skin sealant to areas covered by adhesives should reduce epidermal stripping (Skin Prep, Smith Nephew, Largo, Fla). A moisture barrier ointment is used to protect peri-wound skin from maceration (Proshield Plus, Health Point Medical, Fort Worth, Tex). Some clinical considerations are unique to this product. Wounds treated with collagen might initially appear larger because of the reduction in edema and necrotic tissue. An increase in drainage might also occur. Patients who are sensitive to bovine materials should not use this product. Wound treatment plans will continue to be as varied as the practitioners who devel-
Gill and Griffin 45
T a b l e 2. S a m p l e w o u n d c a r e p r o c e d u r e : Kollagen Medifil Particles 1. Irrigate wound with wound cleanser. 2. Apply moisture barrier ointment to periwound skin and skin sealant to areas under adhesive after skin is dry. 3. Apply 7," thickness of Medifil particles to wound bed surface. (This is for moderate to heavy draining wound. May decrease to light coating of wound bed after drainage is minimal). 4. Apply gauze moistened with normal saline solution to wound; do not pack tightly. 5. Cover with foam dressing. 6. Secure with transparent film dressing(s). Change once or twice daily until drainage decreases, then change every 2 to 3 days.
op them in part because of the diversity of patient populations. Clinical research comparing different products under controlled, nonindustry-based research protocols is lacking. As wound care practitioners, we are charged with evaluating and selecting a clinically effective therapy while considering cost. REFERENCES I. Bennett NT, Schultz GS. Growth factors a n d w o u n d healing: part II.Role in normal and chronIc w o u n d healing. A m J Surg 1993;166:74-81. 2. W i e m a n TJ, Smlell JM, Su Y. Efficacy and safely of topical gel formulation of recombinant human-derlved growth factor-BB (becaplermin) in patients with chronic neuropathlc diabetic ulcers: a phase III,randomized, placebo-controlled,double-blind study. Diabetes Care 1998; 21:822-7. 3. d'Hemecourt PA, Smiell JM, Karlm MR. Sodium carboxymethylcellulose aqueous-based gel vs. Becaplermin gel in patients with nonhealing lower extremity diabetic ulcers. W o u n d s 1998; 10:69-75. 4. Steed DL, the Diabetic Ulcer Study Group. Clinical evaluation of recombinant h u m a n platelet-derlvedgrowth factor forthe treatment of lower extremity diabetic ulcers. J Vasc Surg 1995;21:71-81. 5. Horch RE, Stark GB. Comparison of the effectof a collagen dressing and a polyurethane dressing on the healing of splitthickness skin graft donor sites. Scand J Plast Reconstr Surg H a n d Surg 1998;32:407-I 3. 6. Kolenik SA III,McGovern TW, LeffellDJ. Use of a Iyophnlzed bovine collagen matrix in postoperative w o u n d heallng. Dermatol Surg 1999;25:303-7. 7. Mian M, Beghe F,Mian E. Collagen as a pharmacologlcal approach in w o u n d healing. Int J Tissue React 1992;14(Suppl):1-9. 8. Morris EJ, Dowlen S, Cullen B. Early clinical experience with topical collagen in vascular w o u n d care. J W O C N 1994;21:247-50. 9. Van Glls CC, Roeder B, Chesler SM, M a s o n S. Improved heallng with a collagen..alglnate dressIng in the chemlcal matrlcectomy. J A m Podlatr M e d Assoc 1998;88:452-6.