Treatment of Fournier’s Gangrene With a Novel Negative Pressure Wound Therapy System

  Abstract: Fournier’s gangrene (FG) is a complex condition that requires surgical debridement, hemodynamic support, antibiotics, and appropriate wound management. This study is the first to assess the use of a low-vacuum negative pressure wound therapy (LV-NPWT) system with low-adherent contact surface in two cases of FG. Methods. The protocol-of-care included twice weekly dressing changes and irrigation with a povidone-iodine-water mixture. Assessments included wound progression (% granulation tissue), ratings of dressing ingrowth, pain during treatment and at dressing changes, patient comfort, and ease-of-use. Results. A 51-year-old man (Patient A) developed FG after surgical removal of a perianal abscess. He received 16 days of LV-NPWT with five dressing changes. A 64-year-old man (Patient B) with multiple comorbidities, developed FG after traumatic injury. He received 20 days of LV-NPWT with six dressing changes. In both patients, LV-NPWT promoted rapid granulation tissue formation. Pain scores averaged low-to-moderate during treatment and dressing changes, and tissue ingrowth was minimal. Conclusion. Overall, ratings were favorable for LV-NPWT ease-of-use and patient comfort. Despite the complexity of these wounds, with the use of LV-NPWT, both wounds progressed to a point where they were able to successfully receive surgical closure with skin grafts and/or flaps. These cases may suggest that LV-NPWT may have a potential role in complex wound management.

Introduction

  Fournier’s gangrene (FG) is a life threatening condition characterized by an acute, often polymicrobial, necrotizing soft tissue infection of the perineal and genital region, possibly extending into the abdominal wall.^1–7 Fournier’s disease can occur in both males and females.² Diabetes mellitus, vascular disease of the pelvis, morbid obesity, alcoholism, and intravenous drug abuse are found to be frequently cited predisposing comorbidities for FG.¹ Microorganisms often involved include Streptococci, Staphylococci, Enterobacteriaceae, anaerobic organisms, and/or fungi.¹   Standard multidisciplinary management of FG consists of urgent and aggressive surgical debridement, intensive hemodynamic support, and stabilization combined with broad-spectrum antibiotics.^1–7 Surgical debridement, repeated if necessary, will result in large volume deficit wound(s) requiring further wound bed preparation before surgical reconstruction with skin grafts and/or muscle flaps can be performed.   Besides daily dressing changes and/or hyperbaric oxygen therapy, one documented option for wound bed preparation is the application of negative pressure wound therapy (NPWT) also referred to as topical negative pressure (TNP).^4–10 NPWT involves the application of a controlled subatmospheric pressure to a wound bed. The vacuum is generated by a pump and subsequently conducted and diffused to the vacuum-sealed wound bed by a specialized NPWT dressing.   Mechanisms of action attributed to NPWT include an increase in blood flow, promotion of angiogenesis, reduction in wound surface area, positive modulation of the inhibitory contents of wound fluid, induction of cell proliferation, reduction of edema, and bacterial clearance.¹¹   The first commercially available system for NPWT, V.A.C® Therapy (KCI, Inc, San Antonio, TX), was developed in the 1990s.^12–14 Since then, several other NPWT systems have been commercialized. Two dressings are commonly used in NPWT: foam (polyurethane foam, polyvinylalcohol foam) and gauze (fluff dried 100% woven gauze with a crinkle-weave pattern). Generally, -125 mmHg is considered as standard negative pressure during NPWT, but the most efficacious level of negative pressure remains a subject of debate with opinions ranging from -40 mmHg to -150 mmHg.^{11, 15–17}   Another option for applying NPWT is the Engenex® Advanced NPWT System using the Engenex® NPWT pump with Bio-Dome™ Wound Interface Dressing ([LV-NPWT], ConvaTec, Inc, Skillman, NJ—Engenex and Bio-Dome are registered trademarks of Boehringer Technologies, LP). The dressing is composed of nonwoven polyester layers joined by a silicone elastomer with a low adherent contact surface containing numerous void spaces. Due to the unique properties of the dressing negative pressure is applied at lower vacuum ranging from -30 mmHg to -75 mmHg.   The objective of these case studies was to assess the use of LV-NPWT in the preparation of FG wounds for surgical closure. To date, there are no published studies on the use of LV-NPWT in these types of wounds.

Patients and Methods

  Between December 15, 2009 and July 5, 2010, two patients diagnosed with FG were included in a study to evaluate the performance of LV-NPWT. Experienced plastic surgeons and local NPWT experts in the Department of Plastic & Reconstructive Surgery, Gent University Hospital (Belgium) assessed NPWT suitability of the debrided wounds. Patients were admitted to the University Hospital Burn Center for wound care and informed consent was obtained in both cases.   Protocol of care. The protocol-of-care included dressing changes performed twice weekly. There was ongoing evaluation of the wound condition, patients’ clinical presentations, and LV-NPWT functioning to assess the need for any changes in protocol. At each dressing change, the wounds were irrigated with a mixture of 10% povidone-iodine dermal solution and 90% tap water.   The LV-NPWT dressing was cut-to-size and applied directly onto the wound bed, completely covering the wound bed without overlapping intact skin (as per manufacturer’s instructions for use). Undermined areas were loosely filled with Engenex® Tunnel dressing (ConvaTec, Inc, Skillman, NJ). The testes and penis were enveloped in a layer of paraffin gauze followed by a layer of Aquacel® Ag (100% sodium carboxymethylcellulose dressing) Hydrofiber® silver dressing (ConvaTec, Inc, Skillman, NJ) enabling their inclusion into the NPWT dressing while shielding them from the actual effects of NPWT (Figure 1).   Body entrance points of perineostomy and suprapubic catheters were sealed from LV-NPWT with paraffin gauze and a layer of hydrocolloid paste to prevent urine from leaking into the wound during LV-NPWT (Figure 2).   Vacuum level was set at -75 mmHg with possible adjustments ranging between -30 mmHg and -75 mmHg during the entire treatment with LV-NPWT.

Assessments

  On a daily basis, the NPWT dressing and system was examined, to confirm adequate functioning.   At each dressing change, wounds were evaluated clinically based on the percentage of eschar, slough, granulation tissue and epithelial tissue, the presence of inflammation/infection, irritation, hypergranulation, and odor. Wound swabs for microbiological semiquantitative and qualitative investigations were harvested on admission, if possible, the day prior to starting treatment, the first day of treatment, and at each dressing change.   Further assessments included ratings of dressing ingrowth, pain and itching experienced by the patient during treatment and at dressing changes, patient comfort during therapy, LV-NPWT ease-of-use, ease-of-dressing removal, and ease-of-dressing application.   Dressing ingrowth, wound odor, pain, and itching were rated on numerical assessment scales ranging from 0 (none) to 10 (extreme). Patient comfort, LV-NPWT ease-of-use, ease-of-dressing removal, and ease-of-dressing application were assessed on a 5-point Likert scale.   Laser Doppler imaging (Moor instruments) was completed on Patient A to assess blood circulation levels of the wound bed before initiation and at first dressing change after 3 days of LV-NPWT.

Results

  Patient A. Patient A is a 51-year-old man with type 2 diabetes mellitus who had a perianal abscess surgically removed on January 8, 2010. He was diagnosed with FG on January 11, 2010 and was admitted to the intensive care department of Gent University Hospital on January 12, 2010.   Initial debridement included necrotectomy of a large part of the abdominal wall. The skin of the penis and scrotum was removed. The testicles were spared because they were still vital. A diverting colostomy was performed. Microbiological analysis revealed the presence of Propionibacterium sp and Candida non glabrata. Due to the polymicrobial infection, initial wound treatment in the Intensive Care Unit, before commencement of LV-NPWT, consisted of daily rinsing with sterile saline solution followed by the application of povidone-iodine soaked gauze for cavities and povidone-iodine gel and paraffin gauze for the rest of the wound. Primary dressings were covered by dry sterile gauze dressings.   Additional surgical revisions and/or debridements by a multidisciplinary team of abdominal surgeons, urologists, and plastic surgeons were performed on January 14, 15, 17, and 18, 2010. LV-NPWT was then initiated on January 25, 2010 (Figure 3). Vacuum level was set at -75 mmHg and maintained during the entire period of LV-NPWT.   Laser Doppler imaging (Moor Instruments) completed before the first dressing application and at first dressing change (3 days later) demonstrated an increase in blood circulation in the wound bed (Figure 4).   LV-NPWT was interrupted for 1 day (February 8, 2010) during the NPWT treatment period for suspicion of bacterial problems (Pseudomonas aeruginosa) due to the green color of the NPWT dressing. During the day of therapy interruption, the wounds were treated with povidone-iodine gel and paraffin gauze covered with dry sterile gauze.   LV-NPWT promoted quick granulation tissue formation with a 74% increase by the first dressing change, which continued until approximately 97% granulation tissue formation was achieved, at which point LV-NPWT treatment was stopped (Table 1).   LV-NPWT was ceased on February 11, 2010 and the remaining defect was successfully closed on the same day with autografts (Figure 5). The patient had a total of 16 days of LV-NPWT with 5 dressing applications. Time per dressing change averaged 126 minutes due to the complexity of the wounds.   The patient reported an average pain level of 0 during NPWT treatment and 4.2 during dressing changes. Dressing ingrowth was rated an average of 3.25 (Table 3). There were no reports of complications from LV-NPWT.   In a second stage operation (June 24, 2010), a latissimus dorsi flap was applied to provide more support to the abdomen.   Patient B. Patient B is a 64-year-old man with a medical history including alcoholism, Korsakov’s syndrome, type 2 diabetes mellitus, neuropathy, epilepsy, and arterial hypertension. FG developed after a traumatic injury (falling and striking his penis/scrotum on a counter). The patient couldn’t remember the exact date of the accident. He was admitted to Gent University Hospital on June 21, 2010.   Initial debridement included resection of the perineum, scrotum, and penile skin until the fascia abdominis was exposed. The testicles were spared because they were still vital. Complete necrosis of the corpus spongiosum and the urethra was observed necessitating an urethraectomy.   Microbiological analysis revealed Streptococcus milleri and Enterococcus. Due to the polymicrobial infection, initial wound treatment in the burn center, before commencement of LV-NPWT, consisted of daily showering and disinfection with chlorhexidine followed by the application of paraffin gauze with povidone-iodine gel for the testicles, and paraffin gauze with topical antibacterial (Nitrofural) ointment for the rest of the wound. Primary dressings were covered by dry, sterile gauze dressings.   Additional surgical revisions and/or debridements by a multidisciplinary team of urologists and plastic surgeons were performed on June 22 and July 1, 2010. LV-NPWT was initiated on July 5, 2010 (Figure 6). Vacuum level was set at -75 mmHg and this was maintained until the fourth dressing change where vacuum level was decreased to -65 mmHg because the patient reported increased pain during LV-NPWT (pain had risen from 2 to 7 on the 10-point Likert scale).   LV-NPWT was interrupted for 1 day (July 19, 2010) during treatment for suspicion of bacterial problems (P aeruginosa) due to the appearance of a green color on the LV-NPWT dressing. During the day of therapy interruption, the wounds were treated with povidone-iodine gel and paraffin gauze covered with dry sterile gauze.   LV-NPWT promoted quick granulation tissue formation with a 205% increase by the first dressing change, which continued until approximately 97.8% granulation tissue formation at the point when LV-NPWT was stopped (Table 2).   Pain ratings by the patient averaged 4.0 during NPWT and 4.8 during dressing changes. Decreasing the vacuum setting to -65 mmHg did not continuously decrease pain level during NPWT after the fourth dressing change, which is not abnormal due to the sensitivity of the wound area. Ratings of dressing ingrowth averaged 2.50 (Table 3). There were no reports of complications from LV-NPWT.   LV-NPWT ceased on July 25, 2010 and the remaining defect was successfully closed with a pedicled anterolateral thigh flap on July 26, 2010 (Figure 7). The patient had 20 days of NPWT with a total of 6 dressing applications. Time per dressing change averaged 84.5 minutes.

Discussion

  For both cases, the FG wounds improved significantly during LV-NPWT and the wound bed was successfully prepared for surgical closure. There were no reports of NPWT-related complications, such as toxic shock syndrome, uncontrolled blood and fluid loss, or anaerobicwound infections. Neither patient developed fever during the NPWT treatment period, suggesting it provided a safe wound treatment option for these patients.   Like other NPWT systems, based on the rating in these cases, the LV-NPWT system was neither easy nor difficult to use, was somewhat difficult to apply, and somewhat easy to remove, which is logical, taking into account the complexity of the wounds in both patients. Similar to other systems, the LV-NPWT system requires training to build expertise and comfort with use of the device, as the results obtained by any NPWT system inevitably depend, to a very high degree, upon the expertise of the clinician applying the system. The authors believe the training required is not a limitation to product usage, as it is important to keep an open mind for new developments and treatment options.   Coincidentally, in both patients, LV-NPWT was interrupted for 1 day due to suspicion of a bacterial infection (P aeruginosa). Interrupting LV-NPWT was a precautionary measure in both cases; wound swabs revealed colonization by P aeruginosa, but critical colonization or infection was never diagnosed. The most probable cause of P aeruginosa contamination in both patients was the location of the wounds.   LV-NPWT is equipped with modern performance characteristics.¹⁷ Constant suction force of the LV-NPWT system is freely selectable within the limits preset for this NPWT system (maximum pressure of -75 mmHg and minimal pressure of -35 mmHg). The system has compensation mechanisms for small air leaks. Battery operation is not a problem since it has a 16-hour battery life. Various useful alarms are present, and patient mobility is possible depending upon localization and extent of the dressing, which is similar to other NPWT systems.   The complexity of the wounds described here is a challenge for any NPWT expert. In both cases, LV-NPWT performed as well as one might expect from any NPWT system presently commercialized.   Laser Doppler imaging (Moor Instruments), only executed in patient A before first dressing application and at first dressing change, demonstrated an increase in blood circulation in the wound bed after only 3 days of LV-NPWT. This increase in local blood circulation is likely an important, if not the most important, effect of NPWT on a wound, since it is also closely correlated to granulation tissue development—none of the adjunctive therapies, such as topical antimicrobials, predominantly used during patient treatment before LV-NPWT and to lesser extent during LV-NPWT, demonstrated such an effect.   Wound treatment alternatives for LV-NPWT would be “standard” NPWT, allografts, dressings applied to create a moist and/or topical antimicrobial wound environment, and hyperbaric oxygen therapy. The effects of these treatment alternatives in both case reports can only be based on assumption, unless this was a comparative study, which it was not. Both LV-NPWT and NPWT would have the practical advantage of only two dressing changes weekly, whereas the other treatment options would require more work than that. Hyperbaric oxygen therapy would of course additionally implicate the availability of such infrastructure. When comparing all wound treatment options for FG, besides results and workload, also treatment costs should be considered, which would require much more than a two-patient study.

Conclusion

  The impact of LV-NPWT on wound healing, granulation tissue formation, and wound bed preparation met the authors’ expectations. LV-NPWT was also associated with acceptable mean levels of patient comfort, pain, tissue ingrowth, and ease-of-use. Therefore, future research on the clinical implications of LV-NPWT and how it performs relative to other NPWT systems and/or treatment options is warranted.

Acknowledgements/Conflicts of Interest

  The Department of Plastic and Reconstructive Surgery, Wound Healing and Tissue Engineering Unit, Gent University Hospital, Gent, Belgium, received an unrestricted research grant from ConvaTec, Inc. ConvaTec was not involved in the collection or analysis of data. ConvaTec provided products for the study.

References

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