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EUROPEAN TISSUE REPAIR SOCIETY

PHYSICAL FORCES I

PHYSICAL FORCES I

TOPICAL NEGATIVE PRESSURE (TNP):
THE EVOLUTION OF A NOVEL WOUND THERAPY

P. E. Banwell (Oxford) and Luc Téot (Montpellier)

Topical negative pressure is a novel non-pharmacological therapy that is now being adopted as a standard of care in wound care management programmes. This review assesses where and how it can be best used.

THE cornerstone of wound-care algorithms in surgical practice has been the reconstructive ladder. Wounds may be allowed to heal by granulation tissue or covered with skin grafts, or even local or distant tissues, using pedicled flaps or microvascular free tissue transfer. However, incorporation of topical negative pressure therapy (TNP) into wound management programmes has now enhanced this philosophy (Figure 1). This therapy has extended the indications for simpler surgical techniques in elderly and neurologically-deficient patients and has made it easier to manage complex trauma. An expanding evidence base suggests it should become a mandatory part of the armamentarium of surgeons, nurses and all clinicians involved in wound care.

History and development

Downgrading the reconstructive ladder with TNP

TNP therapy has emerged as a powerful, non-pharmacological tool that can manipulate the wound-healing environment using physical forces. Following Argenta and Morykwas’1,2 pioneering work and that of Fleischmann,3 clinicians and researchers have embraced the technique worldwide.

TNP involves applying a suction force or vacuum across a sealed wound, using a reticulated foam interface. Both the suction effect and the mechanical forces generated at the interface of the foam and wound lead to a variety of changes in the wound, positively influencing the healing process.4,5 Using suction drainage to treat wounds is not new,6,7 and a variety of systems and designs have been used.8–13

Despite a controversial editorial explaining otherwise,14 application of a suction force across the wound using a dressing interface is a patented concept commercially known as vacuum-assisted closure (VAC) (KCI, Witney, Oxon, UK).

Generic terms to describe the therapy and avoid commercial bias have been suggested. They include:

  • Topical negative pressure (TNP)4
  • Sub-atmospheric pressure15
  • Sub-atmospheric pressure dressings (SPD)16
  • Vacuum sealing technique (VST)3
  • Sealed surface wound suction (SSS)17

This review charts some of the latest experimental and clinical evidence for using TNP and highlights some of the applied technologies for the future.

Experimental evidence

Morykwas and Argenta in 1997 were the first to investigate systematically the component parts of TNP’s postulated multimodality mechanism of action.1,2 Since then the improved outcome parameters observed clinically in a variety of wounds have acted as a catalyst for the development of comprehensive research programmes around the world, involving collaboration between vascular biologists, molecular biologists, microcirculatory experts, engineers and biochemists. At present, postulated contributing factors include an increase in dermal perfusion, stimulation of granulation tissue formation, decrease in interstitial fluid accumulation (oedema reduction), decrease in bacterial colonisation, control of wound exudate and reverse tissue expansion effect. There is also evidence for a significant role in tissue salvage. Figure 2 illustrates TNP’s mechanism of action.

TNP’s mechanism of action

Enhanced dermal perfusion

The effect of TNP on the vascular biology of wounds is complex and not fully understood. Initially, the effect on wound perfusion was thought to be the principal result of the therapy. Using needle probe laser Doppler flowmetry, sub-atmospheric pressures of 125mmHg resulted in a four-fold increase in blood flow in an excisional porcine wound model (n = 10 wounds).2 Simple volunteer studies have demonstrated an immediate increase in blood flow in uninjured forearms using a transcutaneous ultrasonic Doppler flow velocity meter18,19 and laser Doppler imaging.20

TNP was also used to treat thirty-two burns in a deep dermal burn wound model. Despite a delay in treatment of six hours, it still resulted in a statistically significant increase in dermal blood flow in burns treated for 72 hours.21 Using a polyurethane foam interface dressing, the changes in blood flow appeared to be pressure-dependent: 2 increasing pressure to 400mmHg across the wounds actually decreased blood flow in excisional wounds.

However, increasing the pressures in a clinical scenario does not necessarily have a deleterious effect on wound outcome as many units in Continental Europe3,22 use high pressures effectively with a polyvinylalcohol foam. This implies that the interface foam dressing may actually be critical in the transmission of pressure.

Of note, early work suggested that a continuous suction regimen led to an eventual decline in blood flow back to baseline readings after five to seven minutes. However, unpublished data from Evison et al. (2002) suggested that even continuous suction may lead to a cyclical pattern of blood flow. Further work is required to investigate this.

These direct effects on the dermal vasculature are thought to be mediated by influencing vasomotor tone and vasoactive mediators. However, the indirect effects of mechanical forces exerted on the extracellular matrix will inevitably affect the microvasculature contained within it. Mechanical stress, therefore, may be the principal effector (personal communication, P. Shakespeare).

Mechanical stress

This has a variety of effects on cellular activity and migration. Indeed, during a keynote lecture at the European Tissue Engineering Society Meeting in Germany, in 2001, Professor Michael Morykwas emphasised that ‘the balance between internal cytoskeletal forces and extracellular matrix forces is critical for control of cell shape, migration, differentiation and tissue patterning’.

While the importance of physical forces in the mechanism of TNP is still hypothetical, there is good evidence that mechanical stress does modulate hard and soft tissue repair23 and angiogenesis.24–28 This has been confirmed by early work in the USA, which suggests a significant effect of mechanical stress (from TNP) on a variety of upstream pathways involved in wound healing.29

Granulation tissue formation

In an excisional full-thickness wound model, alginate impressions were taken daily following treatment with TNP.2 Volume displacement of these casts demonstrated that TNP-treated wounds increased granulation tissue formation compared with the controls by 63.3% and 103.4% (continuous and intermittent suction respectively). However, it was not known what effect contraction played in these dorsal midline wounds.

Another group recently studied the skin-excised rabbit ear wound model and, using a lens micrometer, demonstrated a significant increase in granulation tissue formation. 30 Joseph et al.31 studied granulation tissue formation and commented on new vessel growth and fibroblast morphology, which together with macrophages form the dominant constituents of granulation tissue. However, no attempt to quantify this was made. A number of groups around the world are now investigating the quantitative effect of granulation tissue formation following application of suction.

Reverse tissue expansion

Use of foam dressings and TNP in open wounds, such as abdominal dehiscence, demonstrates the powerful effect of skin stretching or reverse tissue expansion of this therapy. In a closed system, the contraction (shrinkage) of the foam dressing exerts a centripetal effect on the wound edges. There are many similarities between this phenomenon and tissue expansion, which uses silicone balloons to stretch skin for recontructive purposes. Likewise, a number of studies are investigating mitotic rates and angiogenesis in TNP-treated tissue.32

Bacterial colonisation

Experimental wounds in swine inoculated with a human isolate of Staphyloccocus aureus and a swine isolate of Staphyloccocus epidermidis were treated with either TNP or controlled moist saline dressings (n = 5). Daily biopsies were taken for two weeks. Incubated agar plate analysis revealed a reduction from 108 to 105 organisms between days four and five in TNP-treated wounds compared with a mean of eleven days in the control wounds.2 Others have also documented this effect.3,4,22,33–35 Large controlled trials, currently under way, should confirm these findings in a variety of wounds.

Oedema reduction and interstitial fluid

Despite dramatic reduction in oedema formation following treatment with TNP — for example, in burns — and the removal of often large amounts of exudate, there is no quantitative evidence to support a reduction in interstitial wound fluid. Measurement of oedema is notoriously difficult, although high-resolution ultrasound scanners (Longport, USA) are being used in a trial to evaluate changes in skin thickness following TNP (personal communication, T. Adams).

Control of exudate

Exudate management remains a priority in order to minimise labour-intensive, repeated dressing changes which expose practitioners to hazardous, infected material. One of the advantages of TNP therapy is that it utilises a closed system, which adheres to optimal practice guidelines and universal precautions. Furthermore, overall nursing time is significantly reduced as fewer dressing changes are required, especially in chronic wounds. Currently, TNP has a built-in odour control system, although anti-odour factors or antimicrobials (such as silver preparations) could be potentially integrated into the foam. Elevated levels of proteolytic enzymes have been demonstrated in chronic wound fluids and burns.36,37 These may contribute to a non-healing wound environment due to continued matrix degradation.4 High levels of proteolytic enzymes, cytokines and acute-phase proteins have been reported in suction-treated wound fluid and serum.38–40

Salvage of tissue

In reconstructive surgery, burns or following trauma, salvaging tissue may have significant implications for patient outcome. Studies have indicated a potential role for TNP therapy in this respect.

Using a random-pattern flap experimental model in swine, twenty flaps were assigned to a variety of treatment groups including:

  • TNP pre- and post-surgery
  • TNP pre-surgery
  • TNP post-surgery
  • No treatment (controls).

The survival of pre- and post-treated skin flaps was significantly greater than that of the controls (p < 0.01).2 Tissue salvage may also depend on the pressure used and the delivery system – in an experimental model, which used unregulated high pressures with a hole in the drape, wound debridement was required and increased tissue loss occurred. 41

Two studies have indicated that TNP may modulate the so-called ‘zone of stasis’ in burn injury. Use of subatmospheric pressure prevented progression of partialthickness burns, as measured by cell necrosis.15 This may in part be modulated by a diminished inflammatory response. 42 These findings have been confirmed in a human study of deep dermal burn injury.43

Wound-healing research

One of the novel sequelae of vacuum therapy is the ability to collect acute and chronic wound fluid in a reliable, controlled fashion. Simple adaptation of the system with integration of sputum pots allows investigators to quantitate the volume of exudate as well as to collect aliquots – any one of two or more samples – for biochemical analysis (Figure 3).

A number of wound-healing laboratories now use the VAC system to collect wound fluid for wound-healing research, although one group recently devised a novel version called The Stoke Mandeville Device (personal communication, Adams).

Collection system for wound healing research using the TNP and a sputum trap.

Clinical studies and evidence

Trauma Trauma cases can be considered as the best responders to TNP.1,22 Exposed noble structures like bones, tendons and neurovascular bundles are rapidly surrounded and covered by healthy granulation tissue. Patients who are otherwise young and healthy mount a prolific angiogenic response to TNP.

Until recently, most authorities would have considered that soft tissue cover within 72 hours was mandatory in grade III or IV open fractures. Hence, as part of the reconstructive ladder (Figure 1), flaps – muscular, fascial, cutaneous, or compound – have been recommended to prevent bone infection. In certain cases, TNP can now be considered an alternative for preventing infection during the first weeks. However, early and radical debridement of all devitalised tissue, wound lavage, control of permeability of the vascular axes of the involved member, and a perfect immobilisation of the limb are required. These rules must be kept in mind when using TNP.

  • Open tibial fractures TNP treatment can have spectacular results, especially in chronically opened tibial fractures. Covering the tibial bone extremities (inner and outer parts of the cortex) and filling the defect with granulation tissue usually takes from two weeks for small defects to seven to nine weeks for large defects. If healing is not observed, a simple split-skin graft can close the defect.
    Bone grafting may be performed months later if necessary. With TNP, during the acute stage of an open fracture, after vascular evaluation and complete removal of necrotic tissue, oedema is reduced, and granulation tissue fills the different sinuses of these multidirectional heterogeneous wounds.
    Exposed corticospongious bone can progressively be covered by granulation tissue within a mean of two to four weeks, especially when the skin defect is small and located in an area where approximation of the skin edges is less important.
    In other areas, such as the anterior aspect of the leg, the exposed cortical bone can be difficult to cover completely. If the exposed bone surface is limited, drilling into the cortical bone can help stimulate formation of granulation tissue under TNP.
  • Large skin/muscle loss This can be successfully treated using TNP.1,43–46 After complete excision of the non-viable tissues, application of TNP for two to three weeks can prevent local infection and, by retracting the edges and producing granulation tissue, transform difficult-tomanage situations into simple exposed granulation tissue, which can easily be covered with a simple skin graft. This advantage is important in aged or debilitated patients, in whom amputation rates can be reduced. Tissue loss in the foot, simple exposure of tendons or transfixiant loss of substance in gun-shot wounds are also good candidates for TNP. Degloving injuries may also be salvaged.44,47–49
    Promotion of granulation tissue may be more limited or even absent when a large joint is opened. At present, this may be considered a relative contraindication for TNP due to permanent synovial fluid leakage and difficulty in correctly draining the closed space of the joint.
    In distal wounds of the extremities, a flap sometimes leads to an impaired outcome due to excessive volume, poor lymphatic drainage, imperfect colour-matching or chronic instability of the skin over the deep structures.
    Using TNP as an alternative solution in our reconstructive ladder algorithm (Figure 1) can often lead to a better result in terms of function as well as aesthetics16 by stimulating granulation tissue formation followed by a skin graft.

Pressure ulcers
In aged patients, nutritional deficits and polypathology often preclude reconstructive surgery.50 Patients with neurologic deficiencies are at risk due to the absence of neurotrophic neurotrophic factors and an increased propensity to infection. Surgery must therefore be reserved to selected situations. In these situations the quality of granulation tissue is uncertain and TNP can be considered a new tool to promote healing.51–55 Reduced dressing changes (twice a week) also optimise patient care by reducing ‘hands-on’ nursing time while actively treating the wound.4 The amount of pressure applied on these pressure ulcers can be important. This paper’s authors recommend between 150–175mmHg. The only limitation is the risk of pain. In such cases pressure should be titrated accordingly.

In patients with paraplegia, some authors consider that TNP, applied for a short periods, can be used as a woundbed preparation tool before definitive surgical closure.56

  • Grade II, III and IV sacral pressure ulcers These create major skin defects whose tendency to enlarge is due to the mechanical forces exerted on the edges by the large muscles and the convex shape of the sacrum, often exposing the sacral bone. Shear forces often lead to the development of a large undermined area with a narrow skin orifice and a cavity extending laterally.
    Surgical excision of the skin to ensure complete exposure of the wound is necessary before applying TNP. This promotes a circumferential stimulation of the granulation tissue. In very large sacral ulcers, extending close to the anal or genital areas, faecal diversion must also be discussed. Generally, the adhesive films covering the foam can prevent faecal contamination, but local handling difficulties can make it difficult to obtain an effective seal.
  • Trochanteric pressure ulcers Permanent movements of the femoral upper extremity create shear forces, leading to a cavity progressing in depth. The undermined area is often larger than the skin defect, and the foam must fill the cavity completely. A combination of polyvinylalcohol foam in the deep cavity and polyurethane foam across the wound could be used, for example. TNP can facilitate granulation tissue following a large surgical excision of the skin covering the undermined area, except when the capsule of the hip joint is open.
  • Ischial pressure ulcers These usually form deep sharp wounds, often exposing infected ischial bone. The foam, which can also be polyvinylalcohol, must be cut long and narrow in order to fill the cavity. Complete closure can reasonably be expected if the ischial bone infection has been controlled.
  • Heel pressure ulcers Here, the skin tends to retract and coverage of the defect is limited. TNP aids coverage of exposed calcaneum with granulation tissue, but time taken to achieve complete epithelialisation is often prolonged.
    Increasing experience suggests TNP may significantly modulate the local wound-healing environment in some subgroups of wounds that are difficult to manage, such as diabetic wounds. Publications have demonstrated beneficial effects and a large randomised controlled trial is under way.57–60

Leg ulcers

  • Venous leg ulcers In large fibrous venous leg ulcers, circumferentially extending around the leg, TNP can help the progression of granulation tissue, but the results can vary over time. Using alternatively continuous and inter-mittent mode can help. TNP can be used after pinched skin grafts to secure the contact between the graft and the granulation tissue. In these cases care must be taken with the level of suction to prevent physical damage on the freshly applied skin graft.61
  • Mixed-origin and arterial ulcers In mixed-origin ulcers the progression of the granulation tissue is often slow due to the vascular deficiency inherent in this wound. In arterial ulcers the absence of revascularisation prevents healing even after a long period of TNP. Moreover, the foam may create a local necrosis on the skin edges.
    However, TNP can be used as a waiting or holding procedure before a definitive revascularisation surgical procedure.

Other situations

  • Post-sternotomy infections Cardiac revascularisation is one of the commonest elective procedures performed worldwide but postoperative complications are associated with significant morbidity and mortality, particularly wound infections. These may be superficial or deep. The former respond extremely well to TNP,62 which may also be beneficial for deeper wounds, although adequate debridement before definitive flap closure is essential for optimum results. In significant wound infections, maintaining adequate sternal bone stabilisation is problematic as the two parts of the severed sternum may negatively influence respiratory movements, impairing the artificial ventilation. However, a major benefit of TNP is that the crinkled foam acts as a splint and limits the abnormal movements of the thorax.63–67
  • Dehisced abdominal wounds TNP has emerged as an invaluable tool to augment the management of patients with a dehisced abdominal wound. Multiple publications now support its use to bide time, improve the wound bed and facilitate closure of the abdomen.68–73
    Broadly speaking these wounds may be class-ified as type I (superficial), type II (deep) or type III (complex) for the purposes of TNP treatment. Type I wounds may be closed in a delayed primary fashion within ten days; use of foam alone without an interposed dressing is acceptable. In type II (exposed bowel, omentum or mesh) and type III (presence of fistulae) wounds, caution should be exercised in regards to the dressing technique, and an interposed dressing is recommended. Large trials are evaluating the benefits of TNP in this important area.
  • Skin graft fixation Fixation of skin grafts by conventional means is less than ideal, especially in contoured areas where graft take can be suboptimal. The ideal method to maintain skin grafts over a suitable wound bed involves firm fixation, prevention of shearing forces, adaptation to convex and concave surfaces, evacuation of sub-graft haematoma and seroma, and minimisation of infection. Splintage with foam dressings and TNP fulfils these criteria and various studies now support take rates of >90%, even in difficult contoured areas.74–80

Extended uses
Exposed vascular graft can successfully be covered by the granulation tissue after two weeks’ application of TNP. An interface dressing is recommended.
Reported uses of TNP therapy include:

  • Oral and maxillofacial surgery81
  • For spinal exposed hardware82
  • Necrotising fasciitis70
  • Gynaecological problems83
  • Burns84
  • Insect bites85
  • Reducing donor site morbidity86
  • Extravasation injury.87

Contraindications to TNP

TNP cannot be applied on sloughy, infected or necrotic tissue. The wound bed must be prepared, either using surgical debridement or by a progressive local treatment eliminating dead tissues. As mentioned above, the presence of an open joint should also be viewed cautiously.

In all other cases, clinical judgement must be used when applying TNP. In the presence of blood dyscrasias (abnormal clotting), fistulae, open body cavities or in patients following oncological resections, TNP is not necessarily contraindicated. Research shows that it has been used to treat fistulae very effectively.69,71,73

When to stop TNP

A new VAC ATS system.

Excessive pain
Patients may experience discomfort when the foam dressing is changed.88 If pain occurs, the pressure may be titrated accordingly. If it persists or worsens, therapy should be stopped and the wound examined to exclude a serious cause. During the treatment of acute traumatic wounds, the pores of the foam may adhere strongly to the newly developed granulation tissue.

The use of non-adhesive porous interface dressings is recommended at this stage, although it is not known what effect interface dressings have on treatment outcomes. Syringing saline alone or in combination with a local anaesthetic preparation down the drainage tube half an hour before removal of the foam dressing may also facilitate pain-free dressing changes.

Psychological intolerance
Some patients are unable to cope with being attached to mains-operated vacuum pumps. However, ambulatory devices (Figure 4) or machines with batteries now avoid this complication.61

EUROPEAN TISSUE REPAIR SOCIETY

Primary indications for topical negative pressure therapy

No healing response at two successive dressings
If, after seven to eight days of treatment, no positive effect can be seen, or if the local situation deteriorates, indication of TNP must be re-evaluated. Pressure-relieving systems, nutrition and anti- infectious general therapies must be re-checked.

The TRAC System allows feedback from the wound surface.

Frank pus in dressing/cannister
This is an absolute indication to stop treatment.

Excessive bleeding/haematoma under dressing
This warrants cessation of treatment and wound inspection.

The future

This review has highlighted the expanding clinical indications and experimental evidence for using TNP in wound care (Table 1). However, parallel to clinicians’ innovation, we have also seen an evolution in the design of available products from an engineering perspective. In an age of advancing computer technology, we now have more powerful vacuum pumps with the finesse to tailor treatment. The development of the ‘high-tech’ TRAC system enables constant feedback at the foam/wound inter-face and allows monitoring of the local wound environment (Figure 5). At present this measures pressure only, but has the capacity to incorporate other wound diagnostic and therapeutic features in the future.

Thus the concepts of tailored, interactive therapy in wound care are borne together with the possibility of distance control and telemedicine via integrated modems. Combination therapies are also being trialled and researchers have integrated a variety of treatments including the use of tissue engineering and skin substitutes, larval therapy, compression therapy and the installation of drugs.89

Summary of the main points

While the principles of treatment of TNP still hold true to DeBakey’s ideals of being ‘simpler, safer and shorter’,89 the nuances of this powerful, non-pharmacological therapy have now evolved, setting the standards for wound care for the future.

P. E. Banwell, BSc Hons, MB, BS, FRCS
Plastic Surgeon
Department of Plastic Surgery
Radcliffe Infirmary
Oxford, UK
Luc Téot, MD
Plastic Surgeon
Surgery and Burn Unit
LaPeyronie Teaching Hospital
Montpellier, France.
Email: paul@paulbanwell.co.uk

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  64. Harlan, J.W. Treatment of open sternal wounds with the vacuum-assisted closure system: a safe, reliable method. Plast Reconstr Surg 2002; 1092: 710–12.
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  71. Alvarez, A.A., Maxwell, G.L. and Rodriguez, G.C. Vacuum-assisted closure for cutaneous gastrointestinal fistula management. Gynecol Oncol 2001; 803: 413–16.
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  76. Banwell, P.E. Skin graft fixation. Br J Oral Maxillo Surg 1998; 36: 6, 480–81.
  77. Banwell, P.E., Gillespie, P.H., Inglefield, C. and Holten, I.W. Use of topical negative pressure and foam dressings for skin graft fixation. Wound Rep Regen 1999; 74: A247.
  78. Blackburn, J.H. 2nd, Boemi, L., Hall, W.W. et al. Negative-pressure dressings as a bolster for skin grafts. Ann Plast Surg 1998; 405: 453–57.
  79. Scherer, L.A., Shiver, S., Chang, M. et al. The vacuum assisted closure device: a method of securing skin grafts and improving graft survival. Arch Surg 2002; 1378: 930–33; discussion 933–34.
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  81. Avery, C., Pereira, J., Moody, A. and Whitworth, I. Clinical experience with the negative pressure wound dressing. Br J Orl Maxillo Surg 2000; 384: 343–45.
  82. Yuan-Innes, M.J., Temple, C.L. and Lacey, M.S. Vacuum-assisted wound closure: a new approach to spinal wounds exposed hardware. Spine 2001; 1: 263: 130–33.
  83. Argenta, P.A., Rahaman, J., Gretz, H.F. 3rd, et al. Vacuum-assisted closure in the treatment of complex gynecologic wound failures. Obstet Gynecol 2002; 993: 497–501.
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  85. von Gossler, C.M. and Horch, R.E. Rapid aggressive soft-tissue necrosis after beetle bite can be treated by radical necrectomy and vacuum suction-assisted closure. J Cutan Med Surg 2000; 44: 219–222.
  86. Greer, S.E., Longaker, M.T., Margiotta, M. et al. The use of subatmospheric pressure dressing for the coverage of radial forearm free flap donor-site exposed tendon complications. Ann Plast Surg 1999; 435: 551–54.
  87. Morykwas, M.J., Kennedy, A., Argenta, J.P. and Argenta, L.C. Use of subatmospheric pressure to prevent doxorubicin extravasation ulcers in a swine model. J Surg Oncol 1999; 72: 14–17.
  88. Krasner, D.L. Managing wound pain in patients with vacuum-assisted closure devices. Ostomy Wound Manage 2002; 485: 38–43.
  89. Fleischmann, W., Russ, M., Westhauser, A. and Stampehl, M. Vacuum sealing as a drug release system for controlled local drug administration in wound infection. Unfallchirurg 1998; 101: 649–654.
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