V N Panicker 1, 2, S Chaudhary 2 M J Chehade1,3 S Badhrinarayanan
1Department of Orthopaedics and Trauma, Royal Adelaide hospital, 1 Port road Adelaide, S A 5000, Australia
2 Department of Plastic and Reconstructive Surgery, Royal Adelaide Hospital 1 Port Road, Adelaide 5000, Australia
3.Discipline of Orthopaedics and Trauma, Centre for Orthopaedic trauma and Research, University of Adelaide, Australia
Background :Topical Negative Pressure Therapy (TPNT) has been widely used in the treatment of complex wounds. However, there are few examples in the literature of the use of TPNT with an irrigation solution as an adjunct method to promote wound healing and prevent the need for further debridement. This retrospective case series reviews the clinical outcomes of 10 patients with complex wounds, managed with the help of TPNT with a Polyhexadine irrigation (VACUlta™ with Prontosan® solution).
Method :The author was directly involved in using TPNT with a Prontosan® solution (as the irrigation fluid) in 10 Orthopaedic and Plastic patients with complex wounds, including those with infected metalwork. Polyvinyl (PVA) foam was used as the TPNT interface instead of traditional polyurethane (PU) foam as this structure can tolerate more frequent soaks and irrigation without disintegrating. These cases were monitored closely and the results are documented below (see Summary Table).
Results : 9 out of 10 patients did not require repeat debridement. All patients had positive outcomes
Conclusion: We postulate from observations in this series of complex cases the addes d use of the soak and irrigation serves as an adjunct to promote better wound healing outcomes.The combination of VACUlta™ with Prontosan® irrigation (TNPTi) is still a fairly novel therapy and the encouraging results of this case series suggest that further robust studies are warranted.
Health economics, topical negative pressure with instillation / irrigation, biofilm, bacterial burden.
The practice of using topical negative pressure therapy (TNPT) was first described by Fleischmann et al in 1993 “to promote debridement and healing”(1) whereby the use of this technique in 15 patients with open fractures, 25 patients with compartment syndromes of lower limb and 313 patients with acute and chronic infections of various types. They reported that the treatment resulted in “efficient cleaning and conditioning of the wound, with marked proliferation of granulation tissue”.
Further, positive outcomes were reported by Muller following treatment of 300 patients with infected wounds, and in 1998 Kovacs et al described how ‘vacuum sealing’ could be used for the treatment of chronic radiation ulcers.
Topical negative pressure therapy (TNPT) has become a valuable tool in acute and chronic wound management since being popularized by Morykwas and Argenta in 1996 (2) as a novel method of wound control and treatment. Early work suggested that pressure increased blood flow as evidenced by hyperaemia (14) . Morykwas and Argenta demonstrated these peak blood flows on animal models when measured on a Doppler ultrasonography with a 125mmHg negative pressure setting (3).
The polyvinyl (PVA) foam used for this mode of therapy is far more robust than the conventional polyurethane foam (PU) used for TNPT as this structure can tolerate frequent soaks and irrigation without disintegrating. Furthermore, this PVA foam has a finer structure with a smaller pore size (60-270µm verses 400-600µm for the PU foam)(2).
In this retrospective study, we followed the patient journeys of seven orthopaedic patients and three plastic surgery patients with complex wounds. As rational health economics drives the health dollar, finding new treatment modes and devices that are both effective and cost-efficient is an ongoing challenge. Results seen with the use of topical negative pressure in complex wounds are well reported in the literature but the use of this technology, the VACUlta™ with the added use of an irrigation solution, Prontosan® (TNPTi)our study shows promising results (see fig. 1).
Fig. 1 The VACUlta™ with the irrigation solution Prontosan™
Gabriel et al. (3) stated that the therapeutic benefits of the irrigation solution assisted with wound cleaning by lowering the wound fluid viscosity, which in turn facilitated more efficient removal of exudate and infectious material. Their work on the outcomes of patients with extremity and trunk wounds with standard TNPT verses TNPT with irrigation (TNPTi) concluded that there was reduction in the number of surgical debridements, reduced length of hospital stay and earlier wound closure.
This mode of therapy negates the need of having two separate devices to achieve the therapeutic outcomes. This device provides conventional topical negative pressure therapy (TNPT) as well as providing an option of allowing for the use of an antiseptic solution which, not only can be left in the wound as a soak for a specified duration, but can also be used as an irrigation fluid to clean the wound bed and provide an ideal moist environment devoid of bacteria and encourage wound healing. This mode of therapy for such wounds has not been widely reported in scientific literature.
Prontosan® is the solution of choice for all the cases described in this study. This is an antiseptic solution containing 99.8% purified water, 0.1% Betaine (surfactant) and 0.1% Polyaminoprophl Biguanide (Polyhexanide) as a preservative known for its antimicrobial properties. This study concludes that this mode of therapy has the potential to reduce repeated surgical interventions when compared to conventional surgical approaches.
Kim et al. (2014) looked at the outcomes of conventional TNPT verses TNPT with instillation or irrigation (TNPTi) and concluded that the latter therapy was more beneficial for the adjunctive treatment of acutely and chronically infected wounds that required hospital admission (7). This was reinforced by Gabriel et al. (2014) who concluded that TNPT with irrigation appeared to assist with wound cleansing and exudate removal as well as allowing for earlier wound closure compared to conventional TNPT alone (4).
When infected metal implants are removed, there is associated impairment of the affected extremity (14) and sometimes TNPTi may be considered.
In this study, we investigated the efficacy of the use of conventional TNPT, which is known to promote mitochondrial function and improve energy status at the cellular level (5) with the added use of an irrigation solution on a series of complex wounds including orthopaedic cases with infected metalwork. The outcomes of these study merits further study.
This case involved a 42 year old man who was involved in a high speed motor vehicle accident and had a right tibial shaft fracture with minimal soft tissue injury. He had an intramedullary nail fixation and wound closure. He presented back to hospital 6 days’ post discharge with excessive exudate from the suture site, pyrexia and wound infection (see figure 2).
Fig.2 Tibial shaft fracture showing exudate 6 days post-surgery
Thorough debridement and washout of the wound under antibiotic cover was done. The TNPT with the irrigation (TNPTi) solution was then commenced immediately post-surgery (see fig. 3).
Fig.3 VACUlta™ in use post-debridement and washout in theatre
The therapy mode was set up as a twenty-minute soak of 50ml of Prontosan® every two hours followed by conventional NPWTi at 125mmHg pressure on a ‘continuous’ setting. The dressings were replaced on the unit twice a week. After just seven days, his inflammatory markers improved significantly and a decision was made to return to theatre for wound inspection and dressing change. On inspection in theatre, the wound was found to be clean and suitable for closure which was undertaken without a need for further debridement. The patient was discharged the following day with a view to continued antibiotic suppression of assumed infection of metalwork until the fracture was united and metalwork could be removed.
Four weeks after removal of his intramedullary nail, he mobilised with a Camboot and was progressing well. X-ray confirmed no secondary displacement. He did present with an eczematous dermatitis of the affected leg which responded well to a course of topical steroid therapy.
At his follow up appointment, wound appeared to heal well, and no obvious concerns were noted.
Case 2 was a T7 paraplegic who presented to the hospital with grade IV pressure sores to his right and left trochanters as well as a grade III sacral pressure injury (See fig. 4a)
Fig. 4a Pre debridement Fig. 4b post debridement
He had his wounds debrided under antibiotic cover and the wounds managed with TNPTi. In view of the extent of the wounds and the risk of faecal contamination, a discussion with the patient was held and he agreed to undergo a diversional colostomy.
The wounds had exposed bone on view and a scan confirmed osteomyelitis of both greater trochanters. He was seen by the Infectious Diseases team and commenced on appropriate antibiotics. His TNPTi dressings were changed twice weekly for 3 months followed by weekly dressing changes for a further 6 weeks. He also was commenced on Arginaid supplementary drink to aid wound healing. Two months later, his IV Vancomycin that he was on was ceased and he was prescribed oral Doxycycline 100 mg twice a day, Amoxicillin 1 gram TDS and Metronidazole 400mg BD. The author who has over 30 years experience working in a level 1 trauma hospital managing complex wounds from Plastics, orthopaedics, spinal and dermatology would like to postulate based on observation that the wound healing in this individual was quite remarkable (see figure 4b, 4c). His right trochanteric wound
defect was covered with a Tensor Fascia Lata (TFL) flap (see Fig. 4c). The same was done two months later to the left tronchanteric wound when he was able to lie on the initial surgical site. His sacral wound healed by secondary intention (see fig. 4d).
Fig. 4c TFL flap cover Fig. 4d healed sacral defect
Case 3 was a 47 year male who sustained a fracture of his tibia and fibula in a motor vehicle accident presented back into the hospital with a wound infection one month after he had been stabilised with plates and screws. His right leg was erythematous, tender and he was pyrexial. His CRP was 160.
He was taken to theatre as he had a purulent discharge from his wound site which was malodourous. Because of this, a debridement and washout was carried out on the same day. TNPTi was commenced in theatre and the dressings were changed twice a week. A 10ml amount of Prontosan® as a soak for 20 minutes every three hours was programmed into the machine followed by conventional TNPT – (see figure 5).
Fig. 5a & 5b The wound post-surgical debridement and washout
Tazocin 4.5gTDS and Vancomycin 1.5mg BD was commenced under the direction of the infectious Diseases Team.
Two days later, he was taken back to theatre wherehe had a removal of bone graft and insertion of cement antibiotic spacer to his right tibia. He was reviewed by the Infectious Diseases team and his Vancomycin was ceased. The culture sent from theatre grew Staphylococcus Aureus as before. He had a removal of his Trigen Tibia nail and underwent reaming of his tibia. He had the Hoffman external fixator and continued on the TNPTi which was initially increased to 30mls every 3 hours but due to fluid oozing out of his dressing, this was reverted back to 10mls every 2 hours.
On day 6, he had the removal of the Hoffman external fixator and the application of the Illizarov frame for non-union of his right tibia. The TNPTi was ceased and he was allowed to touch weight bear (10kg) and mobilized with one assist and a frame.
He had a custom made orthotic shoe (with 5 cm built up) on day 8 post surgery and he was able to mobilize with a frame.
He was discharged on 6 weeks of intravenous Tazocin via the Baxter infusion set. He was followed up at the outpatients’ clinic and on completing his course of antibiotics, he was given an oral course of Augmentin Duo Forte. His CRP was 15. The only concerns were some oozing from the pin sites of the anterior lateral and posterior medial areas which responded well to topical dressings. He was scheduled to have the Illizarov frame removed in theatre. His follow-up visits confirmed that his wound healed without further concerns.
A 54-year-old man presented with a compound right tibia/fibula fracture following a motor vehicle accident and had this fracture stabilized with plates and screws as the fracture was at the distal end of his leg (see fig. 6).
He presented back into hospital with a wound infection, sepsis and investigations confirming osteomyelitis. He had all metalwork removed and had the application of the Hoffman’s external fixator for stabilisation. He had the TNPTi commenced post-operatively. The machine was programmed to provide a soak time of 20 minutes of 30mls irrigation fluid every two hours as per the treatment regime. The dressings were changed every three days and after 19 days of this therapy regime, his inflammatory markers improved remarkably. Microbial culture showed Staphylococcus Aureus. He was commenced on intravenous Cephazolin 2 grams TDS for 4 days, IV Metronidazole 500mg BD for 4 days and then on oral Amoxicillin/ Clavulanic acid 875/125mg BD for a further 7 days.
Fig. 6 Post removal of sutures and post-debridement in theatre
Six weeks later, the external fixator was removed and the wound defect was primarily closed and he was discharged the following day with crutches. His follow-up visit confirmed that the wound healed well with no complications.
Following a motor bike accident, this patient was retrieved from his local hospital with multi-traumaic injuries He alsosustained a compound fracture of his tibia and fibula and an open wound to his right leg (see Fig. 7) .
Fig 7 Right leg – the initial trauma and the X-ray showing the compound fractures
He was taken to theatre by the Orthopaedic team and had a debridement and washout The fractures were stabilised with external fixation and the TNPTi was set to 50mls soak for 20 minutes every two hours followed by continuous TNPT. After 4 days, the wound looked clean and his other clinical parameters including his CRP were encouraging too. In view of this, he returned to theatre for internal fixation to the fractures and a latissimus dorsi free flap to cover the defect (see fig. 8).
Fig 8 Complex wound managed by TNPT and Free Flap cover of the defect
He was monitored at the high dependency unit of the hospital for a couple of days initially before he was transferred to the Plastic Surgery unit. He was discharged to his local hospital for his follow up rehabilitation after a stay of two weeks.
A 46-year-old male following a motor bike accident sustained a comminuted left patella fracture which was completely displaced. Under antibiotic cover, he had an open reduction and internal fixation with tension wires. Post-surgery, the plan was that he could weight bear with a Zimmer splint after 6 weeks and would commence gentle range of movements after 2 weeks.
As he was pyrexial on admission, he was commenced on intravenous Cephazolin 2gmsTDS and oral Amoxicillin/ Clavulanic Acid 875/125mg BD and was discharged 3 days later.
He presented to the hospital with cellulitis in his affected knee three months later following an altercation in a pub. He had an exploration and washout in theatre and all metal was removed. TNPTi was commenced post-surgery. Wound sterile samples were positive for Mult- drug Resistant Staphylococcus Aureus and he was prescribed 4 weeks of intravenous Vancomycin followed by 6 weeks of oral Clindamycin as per Infectious Disease protocol. He was discharged home a month later (See Figure 9) with the TNPTi changed twice a week.
Figure 9 Infected knee post TNP with irrigation
Figure 10a Gastrocnemius Flap Day 5 Figure 10b Gastrocnemius Flap Day 30
Three weeks post TNPT with irrigation, he was taken back to theatre and the knee defect was explored and had a thorough washout and drainage. The Plastic Surgeons then covered the defect with a gastrocnemius flap with a meshed skin graft to cover the muscle. (See figures 10a and 10b showing the flap 5 days’ post-surgery and one month later.). He was discharged 8 days later with Compression bandages over his knee and he was allowed to mobilize with crutches.
A 65-year-old obese male with a history of alcohol dependency, presented into the hospital following a de-gloving injury to the pretibial area of his right leg (see figure 11a).
Figure 11a Exposed Tibialis Anterior
As the wound was infected with his Tibialis Anterior exposed, his wound was thoroughly debrided and a TNPTi was commenced. His wound tissue grew Enterococcus Faecalis. He had 30 ml of Protosan® programmed as a soak for 10 minutes every 2 hours followed by conventional VAC™ therapy. He was kept as an inpatient as his compliance was questionable and his other co-morbidities needed to be addressed.
The dressings were changed twice a week for a duration of 28 days before granulation tissue covered the exposed tendon (see 11b).
Figure 11b Exposed Tendon covered Figure 11c Skin graft cover
The defect was then covered with a split-thickness skin graft (see figure 11c).
He was allowed to mobilize after day 6 post grafting and was discharged with compression bandages on intravenous Tazocin 4.5g TDS for two weeks and oral antibiotics for a further three weeks as per Infectious Diseases protocol. At his follow up appointment, there were no concerns with the skin graft.
A 47-smale sustained a fracture of left fibula following a motor bike accident. He had his fracture stabilized with plates and screws and since a small defect was noted, I was covered with a Split-thickness skin graft.
He sustained a fall a year later in his bathroom and tore opened his surgical wound. He was commenced on intravenous Tazocin 4.5g TDS due to his soft tissue injury. This was surgically debrided and washed in theatre and a TNPTi was commenced.
Three weeks later, primary closure was undertaken. He was discharged home two days later on oral antibiotics. No problems noted on follow-up review.
Figure 12a Fractured fibula with use of TNPTi Figure 12b Post debridement showing exposed metal
This case was an indigenous female patient with chronic diabetes and renal failure who had a left hip replacement but developed wound dehiscence and severe infection. The wound bed was necrotic and had a purulent exudate which was malodourous. She was taken to theatre for a surgical debridement and TNPTi was applied onto her wound. The machine was programmed to deliver 50 ml of Prontosan solution every 2 hours. The dressings were changed on the ward twice a week. She was commenced on Tazocin 4.5g. TDS by the Infectious Diseases team for two weeks followed by Cephazolin 2g TDS. As she had osteomyelitis.
The wound looked clean two weeks post-surgical debridement and wash-out(see figures 13a and b) and the use of TNPTi helped the wound granulate from the inside but unfortunately the patient succumbed to her co-morbidities and died before surgical closure of the wound could take place.
Fig 13a Osteomyelitis of the hip irrigation Fig13b Post debridement and TNPTi
A 54 year old farmer presented following a crush injury when his right forearm got caught between the rollers of a harvesting machine causing skin loss to both the volar and dorsal aspect of his forearm. He was taken to theatre for surgical debridement and irrigation. He had both extensor and flexor fasciotomies , and carpal tunnel release and topical negative pressure therapy (TNPT) application. He sustained distal ulnar joint displacement of his little finger which was managed conservatively.
Two days later he returned to theatre and had further debridement and a skin graft to cover the soft tissue defect (See figure 14 a and b)
Figure 14 a post-debridement Figure 14b post-grafting
He was taken back to theatre 5 days later as he developed a right digital subcutaneous collection but the skin graft take was reasonable. The collection was incised, drained and turbid fluid was sent for culture. The culture grew Enterobacter species, Pseudomonas aeruginosa as well as Enterococcus faecalis. He was commenced on intravenous Tazocin 4.5mg QID and Metronidiazole 400mg BD. After 3 days, this regime was changed to intravenous Vancomycin 1.5gBD and Amoxil 2g QID for a further 2 days. The Vancomycin was then ceased and Meropenem 1g TDS commenced (and Amoxicillin 2g QID). As there was some undermining just under the grafted site, a decision was made to commence TNPTi. Three days later, the wound was reviewed and there was significant improvement noted with some undermining. However, the exposed extensor tendon was on view. Following two weeks of TNPTi, the exposed tendon was covered with BTM (Biodegradable Temporising Matrix). A split skin graft was used to cover the BTM after 6 weeks and the patient was discharged home 5 days later. The follow-up review was encouraging and the wound did not require any further surgery.
In this retrospective study, we followed the patient journeys of seven orthopaedic patients and three plastic surgery patients with challenging wounds. As rational health economics drives the health dollar, finding new treatment modes and devices that are both effective and cost-efficient is an ongoing challenge. Results seen with the use of topical negative pressure in complex wounds are well reported in the literature but the use of this technology, the VACUlta™ with the added use of an irrigation solution, Prontosan® (TNPTi) from our experience has been very encouraging (see fig. 1).
Gabriel et al. (8) maintains that the therapeutic benefits of the irrigation solution assists with wound cleaning and lowers wound fluid viscosity, which in turn facilitates more efficient removal of exudate and infectious material. Their work on the outcomes of patients with extremity and trunk wounds with standard TNPT verses TNPT with irrigation (TNPTi) concludes reduced number of surgical debridements, reduced length of hospital stay and earlier wound closure.
Fig. 1 The VACUlta™ with the irrigation solution Prontosan™
This mode of therapy negates the need of having two separate devices to achieve the therapeutic outcomes. The device provides conventional topical negative pressure therapy (TNPT) as well as providing an option of allowing for the use of an antiseptic solution which, not only can be left in the wound as a soak for a specified duration, but also used as an irrigation fluid to clean the wound bed and provide an ideal moist environment devoid of bacteria and encouraging for wound healing. There is very little in the literature describing this mode of therapy for such wounds. Prontosan® is the solution of choice in all the cases described in this study. This is an antiseptic solution containing 99.8% purified water, 0.1% Betaine (surfactant) and 0.1% Polyaminoprophl Biguanide (Polyhexanide) as a preservative known for its antimicrobial properties. We conclude that this mode of therapy has the potential to reduce repeated surgical interventions when compared to conventional surgical approaches.
Kim et al. (2014) looked at the outcomes of conventional TNPT and compared this with TNPT with instillation or irrigation (TNPTi) and concluded that the latter therapy was more beneficial for the adjunctive treatment of acutely and chronically infected wounds that required hospital admission (7). This was reinforced by Gabriel et al. (2014) who concluded that TNPT with irrigation appeared to assist with wound cleansing and exudate removal as well as allowing for earlier wound closure compared to conventional TNPT alone (8).
When infected metal implants are removed, there is associated impairment of the affected extremity (14) and this is only considered when no other treatment options are available.
In this study we investigated the efficacy of the use of conventional TNPT (which is known to promote mitochondrial function and improved energy status at the cellular level (13)) with the added use of an irrigation solution on a series of complex wounds including orthopaedic cases with infected metalwork. The outcomes of the study merits further study.
This case involved a 42 year old man who was involved in a motor vehicle accident and had a fractured right tibia shaft. He had an intramedullary nail inserted in theatre and was discharged. He presented back to hospital 6 days post discharge with excessive exudate from the suture site, pyrexia and wound infection (see figure 2)
Fig.2 Fractured Tibia Shaft showing exudate 6 days post-surgery
He was commenced on intravenous Cephazolin 2gms TDS and was taken back to theatre by the surgeon. The surgeon removed some of the sutures from the wound, and thoroughly debrided and washed out the affected area. The TNPT with the irrigation (TNPTi) solution was then commenced immediately post-surgery (see fig. 3).
Fig.3 VACUlta™ in use post debridement and washout in theatre