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Chapter 1 Introduction

1.9 Summary

General principles of CLU treatment

Difficulties in healing CLU are evident in the wide variety of treatment modalities, wound dressing products and elastic compression bandages available.

Treatment of CLU should entail treatment of the underlying condition predisposing to the ulcer and the treatment of the ulcer. Both treatments may be by operative or non-operative modalities. However in view of the chronicity and indolence of these ulcers, various methods, orthodox and non-orthodox are often employed in Nigeria as in most other black African countries 322. Nelzen 23 noted that it has been demonstrated that many young people with leg ulcers treat their ulcers by themselves and do not seek

professional care 22.

Non operative treatment of CLU

Non operative treatment of CLU combines local ulcer care with other measures to heal the ulcer. Slough and necrotic tissue must first be debrided. Non

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operative debridement can be achieved by regular hypertonic saline soaks, larval therapy or topical enzymatic debridement 632. Various dressing materials are being promoted by their manufacturers. However moisture retentive dressings are preferred

298. They help debride necrotic tissue, relieve pain, ease change of dressings and reduce frequency of dressing changes. The dressings serve to protect the wound and provide a moist environment which is best for wound healing. Some dressings have antimicrobial properties. Adjunctive non- operative measures for healing chronic leg ulcers include hyperbaric oxygen therapy, bioengineered skin substitutes, recombinant platelet derived growth factors and vacuum assisted wound closure 298. Some oral medications like zinc sulphate 265 may contribute to ulcer healing.

The majority of venous leg ulcers will heal if patients are hospitalized for continuous leg elevation. However shortage of beds, the increased cost of care and the functional need to maintain the independence of a predominantly elderly population means that hospitalization is not a practical or feasible option 3415.

Venous disease is a sole or contributory cause of many leg ulcers and optimal treatment often includes compression therapy 3426. A number of comprehensive reviews have identified compression therapy as the most important conservative treatment

modality for improving venous ulcer healing rates in the absence of clinically significant arterial disease 3437, 4438, 4539. High compression has been demonstrated to be more successful than low compression and four layer elastic compression bandages are more effective and less expensive than multilayer short stretch bandages 4046. Compression therapy with multilayer graduated high grade bandaging (30 – 40 mmHg at the ankle) has been shown in clinical trials beyond doubt to heal venous ulcers 471. A randomised trial comparing four layer bandaging with conventional ulcer

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treatments showed a significant improvement in healing in the four layer bandaging group with 54% of ulcers healed at three months compared with only 34% in the control group without compression 482. The role of compression as a non-operative treatment option is to increase venous and lymphatic return, reduce oedema and venous pressure in the limb by the application of an external force.

Compression can be achieved using bandages, stockings or in certain circumstances, intermittent pneumatic compression 49. Compression to achieve an external pressure of 30 – 40 mmHg at the ankle is required to prevent capillary transudate and has been considered the mainstay of venous ulcer management 29. However for compression bandaging to be safely applied, the ankle brachial pressure index (ABPI) must not be less than 0.8 50. The bandages should be changed once or twice a week. Some patients have ulcers due to arterial and venous problems and present difficulty in management. In general if the ABPI is greater than 0.5 but less than 0.8, Humphrey et al 51, recommended modified (lighter) compression as a first option. If it is tolerated and appears to be helping the ulcer to heal, then it should be continued. If it is not tolerated or appears to be unhelpful, then the arteries are investigated as for arterial ulcers.

Availability of compression bandages locally and patients’ compliance with the compression therapy are factors to contend with in using compression bandages.

Compression bandaging is uncomfortable for many patients. The higher temperature in our tropical climate generates much heat beneath the compression bandages making it uncomfortable to wear. The skin beneath the compression bandage gets itchy and accumulates desquamated scales which distortsdesquamated scales which distort the skin pigmentation and texture. Patients who cannot effectively conceal

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their bandages with clothes may not want to wear them all the time. Elastoplast is a local improvisation in lieu of appropriate compression bandages.

Some authorsRuckley8 thinks that ulcers are not only difficult to heal with current non-surgical regimens but more seriously that most of them recur 7. The recalcitrance of CLU to treatment is of great concern to patients and the health care providers. This, in addition to the recurring tendencies of the ulcers increases the prevalence rate of the disease. Callam et al2 buttressed these problems, in a

study of 600 patients where he found that a third had never healed their first ulcer and two-thirds had a series of ulcers. Consequently half of the population had had their ulcer disease for more than 10 years, some for virtually their entire adult lives 2.

Moffat et al52 found the The risk factors for poor/delayed healing in patients with chronic leg ulceration to include, the ulcer duration, complexity of the ulcer aetiology, presence of lipodermatosclerosis, history of deep vein thrombosis, thrombophlebitis and pseudomonas wound infection 43. Margolis et al53 studied data on more than 20,000 people with ulcers to try to determine which if any factors predicted complete healing of the wound by the 24Tth week. They found that wounds smaller than 10 square centimetres and less than a year old had about 70% chance of healing by the 24th week, while a wound older and larger than that had about 80%

chance of staying open after 24 weeks 4534.

Recurrent leg ulcerations affect 1 – 2% of Australia’sthe population or between 26 – 69% of patients with ulcers165. Approximately 45 – 90% of all lower extremity ulcers are reported to be venous with recurrence rates ranging from between 26 – 33% for patients who are compliant with wearing compression bandages or hosieries and rising to 69% for non-compliant patients 165. Conservative measures

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have only limited success in preventing recurrence 4545. Hence, additional measures may be needed to prevent recurrence.

Operative Treatment of Chronic Leg Ulcers.

The role of surgery in the treatment of chronic leg ulcers include:

1. Debridement of necrotic tissue and slough from an ulcer 2. Closure of an extensive ulcer.

3. Closure of an ulcer of any dimension where conservative therapy fails 4. Prevention of recurrence in healed venous leg ulcers by eliminating

incompetent veins.

Surgical procedures for chronic leg ulcers include excision and skin grafting of ulcer, excision and flap coverage, while diseased veins can be treated by superficial stripping, excision of varices and subfascial ligation of perforating veins 298. Regardless of the aetiology of chronic wounds, if conservative therapy fails, and healing does not occur, other measures such as the use of skin grafts are indicated 4556. Venous surgery has been shown to be effective in preventing recurrence.

Tenbrook et al56 found an 88% chance of ulcer healing and a 13% chance of recurrence over a short term for patients with severe chronic venous insufficiency treated by subfascial endoscopic perforator surgery 47. Obermayer et al57 studied retrospectively the short and long term effects of healing and recurrence while considering concomitant risk factors in patients who had surgery for currently active, chronic venous leg ulcers. On the basis of their study, they recommended surgical treatment of venous leg ulcers at any stage and concluded that surgery is indicated before an ulcer is intractable to treatment 48. Patients with superficial saphenous reflux with or without perforating and deep vein incompetence benefit from superficial venous surgery 4589. Coleridge-Smith58 noted that this does not speed ulcer healing but

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is effective at preventing recurrence after healing with compression 49. He upheld minimally invasive methods of managing incompetence of superficial saphenous trunks such as endovenous laser ablation, radiofrequency ablation and foam sclerotherapy as being probably effective in treating patients with venous leg ulcers.

He observed that though perforating vein ligation is commonly combined with superficial venous surgery for leg ulcer patients, no systematic data are available to define the role of this treatment. He also noted that insufficient data have been published to allow any general recommendation to be made for the use of deep vein reconstruction to restore competence to deep vein valves as prescribed in some centres 49.

The ESCHAR (Effect of Surgery and Compression on Healing and Recurrence) study 5059, 5601 has reported final results on healing and recurrence rates after treatment with compression with or without the addition of surgery to the veins in people with venous leg ulcers. Leg ulcer healing rates at 3 years were 89% for the compression group and 93% for the compression plus surgery group. Rates of ulcer recurrence at 4 years were 56% for the compression group and 31% for the compression plus surgery group. For patients with isolated superficial venous reflux, recurrence rate at 4 years were 51% for compression alone and only 27% for compression plus surgery. Results were similar in patients with superficial and segmental deep venous reflux (52% versus 24%) at 3 years. In patients with superficial and total deep venous reflux, there was still benefit from superficial venous surgery with leg ulcer recurrence rates improved from 46% with compression alone to 32% with addition of surgery. The authors concluded that most patients with chronic venous ulceration will benefit from the addition of simple venous surgery to reduce ulcer recurrence rates 5059, 5601.

London and Donelly50 advocated that surgery to correct superficial venous incompetence as well as the ligation of incompetent perforating veins may be beneficial, curative and may prevent recurrence 52. However they believe that venous surgery should be reserved for patients who are adherent to medical treatment but fail to respond to conservative treatment measures. They also believe that the mainstay of preventing recurrence in patients with healed ulcers who have not had surgery is graduated elastic compression stockings 52.

Ruffieux et al61 did a long term evaluation of autologous skin grafting in comparison with conservative treatment on 188 chronic leg ulcer patients. For the grafted group, 58% healed in a mean time of 2.2 months, 24.5% relapsed and graft failure rate was 17.5%. However all grafted patients who had painful chronic leg ulcers mentioned a regression of pain after the graft. 87.5% of patients declared that they would accept a new graft. Among the non-grafted chronic leg ulcers, 74.5%

healed in a mean time of 4.7 months. 22.5% relapsed and 3% did not heal. The authors concluded that there was no real difference in closure and recurrence rates between grafted and non-grafted ulcers. They attributed this to an important selection bias related to the methodology of the study in which the grafted ulcers were more serious: they were larger and older 53. Pain relief following skin grafting is an immense advantage worth exploiting instead of relying on analgesics which have adverse effects and no effect on healing. Skin grafting heals the ulcer and eradicates the pain.

Some venous ulcers may need to be debrided of necrotic and fibrinous materials to allow a healthy granulation tissue develop. 28

8. Compression to achieve an external pressure of 30 – 40 mmHg at the ankle is required to prevent capillary transudate and has been considered the mainstay of

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venous ulcer management 28. However for compression bandaging to be safely restore blood supply to compromised limbs 288. An optimal control of associated predisposing factors such as hyperlipidaemia, hypertension and diabetes as well as smoking cessation and an exercise programme should be included in the management plan. Compression therapy is contraindicated and sharp wound debridement is not recommended 288.

The mainstay of treatment of arterial leg ulcers is surgical. The aim is to restore blood supply to compromised limbs 288. An optimal control of associated predisposing factors such as hyperlipidaemia, hypertension and diabetes as well as smoking cessation and an exercise programme should be included in the management plan. Compression therapy is contraindicated and sharp wound debridement is not recommended 288.

Many chronic leg ulcers are managed by a combination of operative and non-operative measures to achieve optimum results.

Neuropathic ulcers require reduction of pressure, sharp debridement of damaged tissues and control of infection 5625. Offloading is primarily used to treat neuropathic plantar ulcers as seen in diabetic foot ulcers. It distributes weight bearing pressure over a larger surface area and provides an interface to decrease shear forces.

Elimination of weight bearing is generally not required. The optimal offloading device is the total contact cast. This device acts to dissipate weight bearing and shearing loads by eliminating foot or ankle motion, using interface material to distribute pressure and shear forces. Venous swelling is lessened by the compression effect of the cast 63. Offloading the foot often requires the use of a protective plaster boot with aA window cut out of the site of the ulcer facilitates wound care. Diabetic foot ulcers in addition require blood glucose control to achieve healing. Becaptermin

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(Regranex), a recombinant human platelet derived growth factor increases the incidence of and decreases the time needed for complete wound closure 5625. After complete healing of the wound, patients should be fitted with foot wear designed to minimize trauma and protect bony prominences 5625.

In sickle cell anaemia, poorly deformable red cells cause hypoxia and infarction of distal ankle skin 5646. Haemoglobinopathic ulcers are resistant to therapy,therapy, tend to be recurrent and cause physical, psychological and social disability 5657. Hypertransfusion therapy to maintain the haematocrit at 30 -35% and the percentage of haemoglobin A (Hb A) at more than 70% appears to benefit some patients with ulcers resistant to more conservative measures 5657. Large ulcers and transfusion resistant ulcers are treated by Sskin grafting. However, blood transfusion and wound debridement may be part of the initial therapy before skin grafting. Skin grafting may unfortunately be complicated by graft failure, then recurrent ulceration

65. is done for patients with transfusion resistant or very large ulcers. But transfusion and debridement are part of the initial therapy before skin grafting. Skin grafting has a high rate of graft failure and later recurrence of the ulcers. 57.

Tropical ulcers require antibiotic therapy to rid the ulcer of infecting bacteria, and local wound care by debridement of slough and by wound dressings. The ulcer may heal on this conservative regime or be closed with a split skin graft when healthy granulation tissue appears.6

Buruli ulcers are treated by wide local excision and closure with split skin graft or a flap.6

Tuberculous ulcers are treated with antituberculous drug therapy and local wound dressings. It may also heal on this conservative treatment or require closure with split thickness skin graft.

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Syphilitic and yaws ulcers require antibiotic therapy, local wound care and with split skin graft or flap.

Neoplastic leg ulcers require tissue diagnosis by histopathological studies of a biopsy specimen following which the ulcer is treated by surgery, radiotherapy, chemotherapy, immunotherapy or a combination of these treatment modalities.

Treatment options in surgery include wide local excision and skin grafting, and amputation of the affected limb with or without lymph node dissection 6.