Reconstruction of Complex Upper Extremity Wounds With Novosorb Biodegradable Temporizing Matrix Versus Integra Collagen-Chondroitin Silicone: A Cost Analysis

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Reconstruction of complex upper extremity traumatic wounds with exposed tendon and/or bone can be costly to patients and the health care system. For many of these wounds, the lack of a vascularized wound bed precludes reconstruction with skin grafting.¹ In appropriate patients, dermal matrices and skin substitutes can be used to create a well-vascularized wound bed amenable to secondary skin grafting.^2-5 Dermal matrices offer advantages over more complex reconstructive techniques because of ease of use, reduced operative times, reduced donor site morbidity, and shorter hospital stays while obtaining excellent functional outcomes.^6-9

Integra collagen-chondroitin silicone (CCS) bilayer (Integra LifeSciences) is currently the most widely used biologically derived template¹⁰ and is composed of bovine collagen crosslinked with shark glycosaminoglycans covered by a removable silicone layer. CCS has been utilized in management of a wide variety of wounds, including upper extremity wounds;^11-18 however, its use is limited by high rates of infection and product cost.¹⁹

A relatively new alternative to CCS is Novosorb Biodegradable Temporizing Matrix (BTM; Polynovo LTD). BTM is a synthetic dermal template made of a biodegradable polyurethane foam and temporary nonbiodegradable polyurethane sealing layer.^6,7,20 Like CCS, histological studies have demonstrated that BTM forms a neodermis and creates a well-vascularized wound bed amenable to skin grafting.^6,21 Many case reports have highlighted the use of BTM in reconstruction of burns, necrotizing fasciitis, and traumatic wounds,^22-25 and previous studies that compared it with CCS found comparable wound closure rates.^10,13,26 However, in these studies the authors also noted that BTM had lower infection rates, skin graft loss, and need for secondary surgery.^10,26

Dermal matrices have been shown to be a more cost-effective option compared to flap reconstruction;^9,27,28 however, no studies to date have compared cost-effectiveness of BTM to the industry standard (CCS). In this study, we compared direct costs between BTM and CCS associated with reconstruction of complex upper extremity wounds. Due to the lower product costs and decreased need for secondary surgery seen in previous studies, we hypothesized that BTM would be a more cost-effective option for reconstruction of complex upper extremity wounds than CCS.

A retrospective, IRB-approved chart review was performed for all patients with isolated upper extremity trauma who underwent reconstruction of complex upper extremity soft tissue defects with either BTM or CCS between January 1, 2017, and May 31, 2022 (Figure 1). Patients were identified using a current procedure terminology query of our electronic medical records. Patients with poly-trauma, burns, admitted for other medical reasons, or use of multiple dermal matrices were excluded from analysis. Demographic data, comorbidities, wound etiology, wound size, secondary surgeries, and complications were recorded. Cost of procedures were determined using Centers for Medicare & Medicaid Services (CMS) Physician Fee Schedule (Table 1). Photo consent was obtained for use of clinical images for patient shown in Figures 2 and 3.

Figure 1. Patient selection flow chart.

Table 1. Cost for Dermal Matrix Reconstruction (USD $)

Figure 2. Full-thickness volar forearm wound after motor vehicle crash. Exposed repaired tendon can be seen prior to application of BTM (tattoo is blurred out). BTM, biodegradable temporizing matrix

Figure 3. Appearance of the forearm on postoperative day 236 demonstrating stable soft-tissue reconstruction after application of split-thickness skin graft. Tattoo is blurred out.

Surgical Protocol

At the time of surgery, all nonviable tissue was debrided before the wound was irrigated and either BTM or CCS was trimmed to fit, oriented according to the manufacturer’s instruction, and then secured with either absorbable sutures or staples. Negative pressure wound therapy or a compressive bolster-type dressing was applied over a non-adherent dressing at the discretion of the operating surgeon. The initial surgical dressing was maintained for 5 to 7 days before transitioning to daily dressing changes consisting of a non-adherent dressing and a lightly compressive wrap. Serial, postoperative follow-up in clinic was performed to assess for template integration, complications, or other issues. Once the BTM or CCS was incorporated, the sealing layer was removed and patients were given the option of skin grafting or continuing local wound care.

A total of 270 patients were identified using our current procedure terminology query, with a total of 27 patients who met our inclusion criteria, 18 (66.7%) BTM and 9 (33.3%) CCS. There were no differences between age (45.4 ± 17.6 years vs 43.8 ± 11.5 years, P = .40), associated medical comorbidities, length of stay (1.83 ± 2.1 days vs 3.11 ± 4.2 days, P = .15), or wound size (101.8 ± 102.8 cm² vs 64.8 ± 100.9 cm², P = .19) between BTM and CCS, respectively (Table 2). There was also no difference in successful wound closure between BTM and CCS, 94.4% vs 77.8%, P = .48, respectively (Table 3).

Table 2. BTM vs CCS Demographics

Table 3. BTM vs CCS Skin graft and outcomes

The BTM group had a lower complication rate compared with the CCS (33%, n = 6 vs 55.6%, n = 5, P = .0018). In the BTM group, 2 patients required return to the operating room (OR) for repeat debridement, 1 patient required replacement of the BTM template, and 1 required additional reconstruction with a local flap. In the CCS group, 3 patients required return to the OR with replacement of CCS. Ultimately, 2 of these patients were reconstructive failures and required revision amputation at the level of distal interphalangeal joint (DIP) in one and local flap closure in the other.

Skin grafting was performed in significantly more patients in the CCS group (5 patients, 55.6%) compared with the BTM group (8 patients, 44.4%), P = .027. For those who required secondary skin grafting, the average size of skin grafting for BTM was 114.0 ± 17.8 cm² and for CCS was 88.4 ± 95.4cm² (P = .23). Time to skin grafting was significantly longer in the BTM group (43.4 ± 13.4 days) compared with CCS (21.4 ± 3.9 days), P = .002. In the group that did not require skin grafting, the average wound size was larger in the BTM group (44.8 ± 39.1 cm², range: 35-190 cm²) compared with the CCS group (17.5 ± 3.5 cm²; range: 12-20 cm², P = .002). Time to wound healing was longer in the BTM group (106.3 ± 47.8 days) compared with CCS (77.0 ± 17.5 days, P = .003) (Table 3).

At the start of the study in 2017, 100 cm² of BTM cost $850 and CCS was $3150 at our institution (Table 1). When wound size for the groups was factored in, the average cost of BTM template placement was not significantly different ($865.5 vs $2040.50, P = .075). The BTM group required significantly fewer OR procedures following template application compared with CCS (0.67 procedures vs 1.56 procedures, P = .049) and when combined with the cost of the product, the average total cost of wound reconstruction with BTM was significantly lower ($1361.92 vs $3185.71), P = .049. When length of stay ($3226 per hospital day), which was not statistically significant between the 2 groups (BTM 1.83 ± 2.1 days vs CCS 3.11 ± 4.2 days, P = .15), was factored in, there was no significant difference between the overall cost between the 2 groups (BTM $7276.25 vs CCS $13,222.15, P = .11) (Table 4).

Table 4. BTM vs CCS Cost Analysis

Dermal matrices are widely utilized in the management of upper extremity wounds for their ability to create a graftable wound bed over exposed bone and tendon with good aesthetic and functional outcomes.^6,7 CCS is currently the most widely used dermal matrix and has demonstrated good results in the management of wounds from a variety of etiologies. However, its high product cost and the infection rates limit its potential applications.¹⁹ Novosorb BTM is a recently introduced alternative synthetic skin substitute that has also demonstrated good clinical outcomes^10,26 and has been shown to be more resistant to infection (Figures 2 and 3; Video 1).¹⁰

Video 1. Video taken on postoperative day 236 demonstrates pliability of the skin graft and tendon gliding.

Previous studies that have compared BTM versus CCS found no significant difference in rates of wound closure with a significantly reduced need for secondary surgery and skin grafting.^10,26 Similar to these previous studies, we found similar wound healing rates between BTM and CCS (94.4% vs 77.8%),¹⁰ a reduced need for secondary skin grafting in the BTM group compared with CCS (44.4% vs 55.6%), and fewer complications (33.3% vs 55.6%).

Total time to wound closure was significantly longer in the BTM group (106.3 ± 47.8 days vs 77.0 ± 17.5 days). This is likely secondary to the longer time to skin grafting (BTM 43.4 days vs CCS 21.4 days), the increased proportion of patients who were allowed to spontaneously re-epithelialize (BTM 56.6% vs CCS 44.4%), and the significantly larger size of wounds that were allowed to heal secondarily (BTM 44.8 ± 39.1 cm² vs CCS 17.5 ± 3.5 cm²). This delay in time to grafting has also been seen in previous studies and reflects the stability of the template, which can be left in place until complete revascularization over exposed tendon and bone is seen; skin grafting, if indicated, can be delayed until a time that is convenient for the patient and surgeon. Despite the longer time to grafting and closure, there was no negative effect on wound healing or complication rates, which were not statistically superior in the BTM cohort.

To our knowledge, this is the first study that compares the direct costs associated with reconstruction of complex upper extremity wounds with BTM and CCS. We have shown that BTM is a cost-effective alternative ($1361.92 vs $3185.71, P = .049), when factoring in template cost and secondary surgery. Based on the current study these cost savings stem primarily from the reduced need for secondary surgery between the 2 groups (BTM 0.67 vs CCS 1.5), which included both need for skin grafting and the significantly lower number of complications and revision surgeries. While there was no statistically significant difference in cost when looking at template prices per 100 cm² in 2017 alone (BTM $865.5 vs CCS $2040.50) or total cost when length of stay was factored in (BTM $7276.25 vs CCS $13,222.15), both variables were trending towards significance (P = .075 and P = .11, respectively) and likely indicate that our study was underpowered to detect a difference.

There are several limitations to the current study, including the retrospective design. This study only examined isolated traumatic wounds, excluding other etiologies such as burns and infections. Because of the strict inclusion criteria used, our study had a relatively small sample size and was likely underpowered to detect differences that were trending towards statistical significance, including hospital length of stay, product cost, and rate of successful wound closure. The price of the product(s) may also vary by institution and from year to year, which could impact the findings of the current study. Unfortunately, due to study design, we were unable to evaluate indirect costs such as time off work or cost of dressing supplies, which might have increased the total costs in the BTM group secondary to the increased time to closure. Despite this, we believe that the increased costs of wound care were likely minimal as many patients were comfortable leaving BTM open to air or simply covering with an ACE wrap after the early postoperative period. Other direct costs such as anesthesia and operating room time were not included because differences between the 2 groups were assumed to be negligible at the index surgery but would likely have further increased the costs associated with CCS reconstruction due to the increased frequency of secondary surgery.

Novosorb BTM is a more cost-effective option when compared with CCS for reconstruction of complex upper extremity soft tissue defects.