Stepwise Surgical Technique Used to Treat Recalcitrant Pretibial Ulcerations: A Case Series

Pretibial lacerations are acute wounds caused by trauma and are a common presentation in the emergency department.^1,2 There can be a significant financial burden to the health care system as well as patient quality of life when patients with refractory ulcerations present to the emergency department instead of a regular wound care clinic. Elderly patients with multiple comorbidities—such as heart disease, history of stroke, chronic obstructive pulmonary disease, dementia, diabetes, cancer, and renal failure—may experience delayed healing of traumatic wounds.² When inappropriately managed, pretibial lacerations often become chronic and difficult to heal due to comorbidities and poor vascularity at the pretibial region.^1,3 The current standard of care for pretibial ulcers generally includes conservative treatment, such as weekly debridement, topical or oral antibiotics, and compressive dressings.¹ This set of conservative treatments may heal the wounds by 12 months.² However, the recurrence rate is 25% for conservative ulcer management and 3% for surgical ulcer management.⁴ Furthermore, variations in wound management may lead to complicated and compromised clinical outcomes. There is a need for a standardized surgical protocol of instruments, techniques, and methodology.

An acellular dermal tissue matrix derived from fetal bovine dermis and embedded with ionic silver (PriMatrix Ag Antimicrobial; Integra Lifesciences) is indicated for management of challenging wounds. Fetal bovine dermis is rich in type III collagen known to promote tissue healing,⁵ and ionic silver is a broad-spectrum antimicrobial intended to prevent microbial colonization of the device.^6,7 This antimicrobial FBADM has been shown in Clinical and Laboratory Standards Institute disc susceptibility testing to be effective against a range of bacteria, including Staphylococcus aureus, epidermidis, Escherichia coli, methicillin-resistant
S aureus, Enterococcus faecium, Klebsiella pneumoniae, Listeria monocytogenes, vancomycin-resistant Enterococcus faecalis, Acinetobacter baumannii, and Streptococcus pyogenes (Group A). Literature has demonstrated the efficacy of antimicrobial FBADM in managing chronic wounds and preventing complications in lower-extremity ulcers.^6,8 In a case study of complex surgical or traumatic wounds in 43 patients treated with antimicrobial FBADM alone, complete wound closure was achieved approximately 95% of the time.⁶ Additionally, antimicrobial FBADM was found to offer an effective alternative treatment strategy for definitive closure of challenging traumatic or surgical wounds in patients who were not suitable candidates for tissue flaps.⁶ Furthermore, in a midsized retrospective comparison of antimicrobial FBADM and Apligraf (Organogenesis), a bioengineered skin substitute, for the treatment of refractory diabetic foot venous stasis ulcers, patients treated with antimicrobial FBADM displayed accelerated healing compared with those treated with the bioengineered skin substitute alone, despite larger initial wound size.^9,10
Wounds are commonly debrided in a parallel plane to the level of the wound, a method that helps remove all necrotic tissue and biofilm. It may be important to regularly fenestrate wounds with a blade or needle. Poon et al performed dermal fenestrations on wounds and found that within “30 minutes of performing fenestration the overall swelling of the foot had been reduced.”¹¹ Controlling the swelling of the area around the wound helps the wound become smaller and eventually heal quicker. It also provides a drain for serous fluid while pluripotent cells, which lie directly under the wound at the level of healthier granulation tissue, migrate to the wound bed.

This case series describes a reliable surgical treatment protocol and a fenestration method combined with an antimicrobial FBADM for the treatment of recalcitrant pretibial ulcerations.

This was a retrospective case review of patients treated for pretibial ulcerations between 2018 and 2020 at the St. Vincent Charity Medical Center Emergency Department in Cleveland, Ohio. Three patients with pretibial ulcerations secondary to mechanical trauma were identified. All wounds had failed to achieve wound healing with conservative treatment consisting of over-the-counter triple antibiotic ointment plus a traditional gauze dressing applied for 6 months.

All 3 patients were over 50 years of age and African American. Each wound was a result of mechanical trauma that deteriorated into a refractory ulceration despite over-the-counter medication. All patients were initially seen in the emergency department and admitted for intravenous antibiotics and surgical debridement. The wound surfaces were measured with a ruler in centimeters before and after debridement.

Patients were brought to the operating room and placed in a supine position. Using aseptic technique, the lower extremity was prepped and draped. Aggressive, excisional debridement was performed using a combination of a #15 blade, a 5-mm ring curette, and a rongeur. Each ulceration was debrided down to the level of healthy, bleeding granulation tissue: Case 1 into the subcutaneous tissue, Case 2 into the anterior tibial tendon and tibial bone, and Case 3 into tendon sheaths. Next, fenestration was performed using a 25-gauge, 1.5-cm hypodermic needle. The wound edge fenestration was performed about 1.5 cm from the healthy tissue with a needle depth of no more than 0.5 cm (Figure 1), which promoted fresh blood to travel to the surface of the wound. The antimicrobial FBADM was prepared by soaking in saline for 60 seconds. The healthy bleeding tissue from the fenestration site was utilized to further saturate the graft by soaking it in the fresh bleeding tissue for 30 seconds until the color of the graft transformed from milky white to blush pink. Case 1 used the fenestrated graft. Case 2 used the solid graft. Case 3 used the meshed graft. The graft was then secured to the wound with monofilament absorbable sutures (Monocryl; Ethicon, Raritan, NJ). The area was then dressed with bacitracin; nonadherent, dry sterile detressing; and a uniform multilayer compression dressing. The patients were all discharged with oral antibiotics and were referred to the wound-care clinic for follow-up. The grafting and the dressing were kept intact for 14 days, at which time the first dressing change was performed. In order to continue to allow the graft to incorporate, no debridement was performed at this time. After 21 days, complete graft incorporation was noted. At this time, the measurements were obtained after gentle debridement using a 5-mm dermal curette to remove biofilm, and the wound was redressed with an Unna boot dressing. During the entire treatment, patients were fully weight-bearing.

All 3 patients’ wounds reached complete wound closure with no complications. Demographic information, wound size, and time to closure are shown in the Table. Mean initial wound volume was 45.8 cm³ (range, 5.2-126 cm³). The mean time to closure was 4.8 months or 21 weeks (range, 9-38 weeks). At 28 days after the graft application, the authors observed significant improvements in wound depth for all 3 cases, with wound volume reductions of 75%, 66.7%, and 50% (Table).

Case 1

A 53-year-old male patient who had had a painful chronic right leg ulceration for the past year presented to the emergency room because of worsening wound characteristics, including discoloration, malodor, drainage, and increasing pain. He injured his leg during a basketball game, and the small laceration was treated with a bandage and triple antibiotic ointment. The trauma never healed properly.  The patient’s medical history was remarkable for diabetes and hypertension, and he sustained a closed pilon fracture 15 years ago that was managed without surgery. He quit smoking 20 years ago.

On admission, the patient had stable vital signs, and laboratory results were within normal limits. On physical examination, pedal pulses could not be palpated or located using a Doppler probe; popliteal pulses were biphasic. Protective sensation was intact. The full-thickness wound was necrotic, purulent, and malodorous with mixed fibrogranular tissue and periwound edema, erythema, and lipodermatosclerosis (Figure 2). There was significant pain on palpation of the wound; muscle strength was intact. Radiographic evaluation revealed a malunion of the previous pilon fracture and soft tissue defect at the level of the wound. The patient had a pulse volume recording, and a vascular surgeon was consulted. The patient had an ankle-brachial index of 0.63 and undiagnosed peripheral vascular disease. He underwent an angiogram with stent placement to improve blood flow for wound healing potential.

Surgical debridement, removal of hematoma, and the previously described surgical technique were utilized, including application of antimicrobial FBADM. After 14 days, the wound depth reduced from 0.3 cm to 0.1 cm. At the 2-month follow-up, 75% wound closure was observed. The patient underwent weekly Unna boot dressing at the wound care clinic. Within 4 months, the patient’s wound was fully healed, and he was able to return to regular activities.

Case 2

A 68-year-old male patient who was wheelchair-bound presented with a painful wound on the left leg sustained 6 months prior when he hit his leg on a metal pole at the grocery store. The wound was small and had been treated with a bandage and triple antibiotic ointment. He presented to the emergency department with worsening symptoms of odor, pain, drainage, and swelling. The patient’s medical history was remarkable for diabetes, hypertension, hyperlipidemia, and hepatitis B. He also had a history of alcohol, nicotine, opioid, and intravenous drug misuse.

Upon admission, the patient had stable vital signs, and laboratory results were within normal limits. The physical examination showed palpable pulses, diminished protective sensation, and a full-thickness ulceration with purulence, malodor, and a mixed hematoma with fibronecrotic tissue (Figure 3). The wound probed to deep soft tissue structures of the anterior tibia with pain around the wound and the calf. Muscle strength was intact.

Radiograph and MRI of the leg showed a soft tissue defect with no subcutaneous emphysema and no periosteal reaction of osteomyelitis. The lower extremity ultrasound showed no deep venous thrombosis. The patient was started on intravenous antibiotics and taken for surgical debridement.

Intraoperatively, the depth of the wound was noted to be 3 cm. The aforementioned surgical technique was used to debride the wound and hematoma. The wound edges were fenestrated and then the graft was applied. After 14 days, the dressing was removed in the wound care clinic. The patient underwent weekly Unna boot dressing changes for 10 weeks. At the 10-week follow-up, 95% closure was observed. This patient was lost to follow-up. Although the patient’s nursing home reported a healed wound, it was unable to provide a clinical photograph.

Case 3

A 53-year-old male patient presented to the emergency department with an increasingly painful wound on his left shin and the emergence of an abscess on the left ankle. He had first sustained an injury to the leg approximately 1 year ago when a car struck him from behind while he was driving his motorcycle around his neighborhood. He scraped his leg when he fell off the motorcycle. The laceration was treated at an urgent care clinic with bacitracin and a tetanus shot. The patient reported that the wound never healed completely and occasionally reopened. His medical history was also remarkable for a resolved giant cell tumor, depression, insomnia, drug misuse, and a total hip replacement 20 years ago due to avascular necrosis. The patient had also been unemployed due to disability.

On admission, vital signs were noteworthy for tachycardia and hypotension, and the patient had lightly palpable pulses with biphasic waveform. Protective sensation was diminished secondary to drug misuse. There was a full-thickness anterior tibial ulceration with a focal pocket of pus to the left ankle, which was tunneling along the anterior tibial tendon and dorsolateral foot (Figure 4). There was proximal streaking, bogginess, crepitus, and no palpable lymph nodes. The range of motion was absent, and muscle strength was diminished. Laboratory studies showed leukocytosis and elevated sedimentation rate. The wound cultures grew S pyogenes and methicillin-resistant S aureus.

Radiographs and CT scan revealed an abscess with soft tissue defect and possible necrotizing fasciitis; the infection was tracking along the tissue planes proximally and distally. The patient was taken to the operating room for immediate incision and drainage, where significant dishwater-pus was drained. The wound was found to have tunneled along the tibialis anterior tissue planes, confirming the necrotizing fasciitis diagnosis. One week later, at the second visit to the operating room, the infection was completely removed and granulation tissue remained. The wound base was healthy enough for application of antimicrobial FBADM. When the dressing was removed at the wound care clinic 14 days after the second surgery, the wound had reduced in size by 40% along the foot and 90% along the anterior tibia (Figure 4D). The anterior tibial wound healed at 4 months, and the foot wound achieved 100% closure at 9 months.

Pretibial injuries can be difficult to heal due to several factors, including comorbidities (such as diabetes, peripheral vascular disease, venous hypertension, cardiac failure, and renal failure),⁶ immune compromise, geographic location, drug misuse, socioeconomic status, and patient nonadherence to treatment. Due to the topographical location, the anterior tibia has poor vascularization with decreased dermal integrity resulting in friable skin, which exacerbates injuries sustained from trivial trauma.^6,12 In addition, common medications such as warfarin, corticosteroids, and aspirin potentiate hematoma formation, which can complicate the management of such wounds.⁶ Often, socioeconomic status affects the at-home treatment of these wounds. For example, without easy access to soap, water, and antibiotic ointment, simple wounds can become chronic ulcerations. Patient lack of adherence to the treatment instructions also can play a large role in the treatment of these wounds. For example, lack of understanding of the treatment plan, lack of a supporting caregiver, or obesity are all factors that may leave patients physically unable to reach their wounds or apply dressings daily; others may not apply dressings that they find too tight or difficult to apply. The combination of these factors can lead to wounds developing larger defects.

In the present case series, the authors describe evaluation of the initial trauma, a surgical technique of fenestration with aggressive debridement, application of an acellular dermal matrix, and instructions to patients about the importance of adherence with constant multilayer compression during the postoperative period. Wound edges are a common factor limiting healing because they tend to stagnate in the chronic phase of wound healing, which allows fresh blood to pool around the wound edges and wound base. This surgical fenestration technique goes one step further than routine debridement and allows for fresh pluripotent cells to stimulate the acute healing process. Puncturing the wound center and border allows for 3 events to occur: (1) hematopoietic cells in the wound remodeling cycle travel to the surface, (2) micro-trauma allows for the wound healing cycle to be restarted from the stagnant phase, and (3) the fresh bleeding tissue allows for a rich moist environment for soaking the graft, enabling optimal incorporation of the graft into the wound bed. Taken together, these events stimulate increased wound healing potential.

All 3 patients received a single treatment with antimicrobial FBADM and saw wound improvement as early as 1 month after treatment, without the need for additional grafting or active therapies (such as activation with saline or daily dressing changes) that are needed in conjunction with other advanced skin substitutes.

Dhaliwal et al found that lower-extremity peripheral artery disease affects approximately 10% of the American population.¹² Approximately 50% of patients with peripheral artery disease are asymptomatic.¹² One of the patients in the present study, a 53-year-old male, had moderate peripheral artery disease with no claudication as well as undiagnosed small-vessel disease. When the patient experienced a small trauma, the simple laceration was unable to heal. Within 4 months of treatment with the combination of a fenestration method with an antimicrobial FBADM, the wound healed despite comorbidities.

Singh et al studied pretibial laceration management.¹ The study included 36 older patients (mean age of 79 years) with pretibial lacerations (mostly Dunkin grade III), and 57% of the injuries resulted from mechanical falls.¹ Median inpatient duration was 11 days for surgical management and 15 days for conservative management.¹ The authors concluded that pretibial ulcerations tend to affect older individuals, and if inadequately managed, will adopt characteristics of chronic wounds and result in a lengthier inpatient stay.¹ Surgical intervention with autologous repair is necessary for extensive injuries. Many studies, including Cahill et al and Tuboku-Metzger et al, have found that conservatively managed patients experience longer hospital stays than surgically managed patients.^1,13,14 Evidence suggests that there is a clear benefit of early mobilization rather than bedrest in grafted pretibial lacerations, with no decrease in the extent of graft take.¹⁵

The antimicrobial FBADM that was used in the present study is indicated for the management of challenging wounds. The dermal collagen fibers of the tissue matrix support cellular repopulation and revascularization, while the ionic silver content acts as a broad-spectrum antimicrobial to prevent microbial colonization when applied on a wound.^7,16,17 Several studies have reported successful use of this antimicrobial FBADM in a variety of indications, including burns, diabetic foot ulcers, venous leg ulcers, and surgical and traumatic wounds,^3,6,10,11,18 and most notably in healing challenging wounds, such as those with exposed bone and tendon and in patients with comorbidities.^3,6,18 In addition, a study by Karr et al showed that fewer applications of this antimicrobial FBADM were required to heal wounds compared with another advanced skin substitute in diabetic foot ulcers (1.5 vs 2 applications, respectively) and venous ulcers (1.3 vs 1.7 applications, respectively).¹⁰ The elasticity of this antimicrobial FBADM allows it to be stretched to cover larger wound surfaces than other advanced skin substitutes.

As a small case series, this report has limitations, including the small number of patients, retrospective data collection, and lack of long-term follow-up after wound closure. The patient population of African American men ranging from 53 to 68 years old reflects a narrow demographic of patients but a wide range of comorbidities and wounds, ranging from mildly infected to severely infected surgical emergencies.

The combination of a fenestration method and one application of antimicrobial FBADM led to wound volume reduction by 75%, 66.7%, and 50% in 28 days. All 3 patients reached complete wound closure with no complications. Mean initial wound volume was 45.8 cm³ (5.2- 126 cm³). Mean time to closure was 4.8 months or 21 weeks (9-38 weeks). The successful healing of recalcitrant pretibial ulcerations in these 3 high-risk patients demonstrated the clinical utility of this fine-needle fenestration method combined with antimicrobial FBADM application for healing of these traditionally hard-to-heal wounds. Prospective randomized trials are warranted to fully evaluate the efficacy and safety of this approach in a more heterogeneous patient population.