Dermal Regeneration Template Research Articles

Early identification of delayed wound healing in complex diabetic foot ulcers treated with a dermal regeneration template: a novel clinical target and its risk factors.

The dermal regeneration template (DRT), a tissue-engineered skin substitute composing a permanent dermal matrix and an upper temporary silicone layer that serves as the epidermis, has demonstrated efficacy in treating uncomplicated diabetic foot ulcers (DFUs). Our institution has obtained good outcomes with DRT in patients with more complicated DFUs. Because of its chronicity, the authors are working to identify a clinical target that anticipates delayed healing early in the treatment in addition to determining the risk factors linked to this endpoint to increase prevention. This retrospective single-center study analyzed patients with DFUs who underwent wound reconstruction using DRT between 2016 and 2021. The patients were categorized into poor or good graft-take groups based on their DRT status on the 21st day after the application. Their relationship with complete healing (CH) rate at day 180 was analyzed. Variables were collected for risk factors for poor graft take at day 21. Independent risk factors were identified after multivariable analysis. The causes of poor graft take were also reported. This study examined 80 patients (38 and 42 patients in the poor and good graft-take groups, respectively). On day 180, the CH rate was 86.3% overall, but the poor graft-take group had a significantly lower CH rate (76.3 vs. 95.2%, P =0.021) than the good graft-take group. Our analysis identified four independent risk factors: transcutaneous oxygen pressure less than 30mmHg (odds ratio, 154.14), off-loading device usage (0.03), diabetic neuropathy (6.51), and toe wound (0.20). The most frequent cause of poor graft take was infection (44.7%), followed by vascular compromise (21.1%) and hematoma (15.8%). Our study introduces the novel concept of poor graft take at day 21 associated with delayed wound healing. Four independent risk factors were identified, which allows physicians to arrange interventions to mitigate their effects or select patients more precisely. DRT represents a viable alternative to address DFUs, even in complicated wounds. A subsequent split-thickness skin graft is not always necessary to achieve CH.

Treatment of Necrotizing Fasciitis With NovoSorb Biodegradable Temporizing Matrix and RECELL Autologous Skin Cell Suspension: A Case Series.

This case series reviews the management of 2 patients who developed a rare, aggressive soft tissue infection, necrotizing fasciitis treated with a synthetic polyurethane dermal regenerative template, Biodegradable Temporizing Matrix (NovoSorb BTM) in conjunction with an off-label use of RECELL device applying autologous skin cell suspension and a split-thickness skin graft for reconstruction. The clinical relevance describes a non-traditional patient's course of treatment and clinical outcome using BTM and RECELL for necrotizing fasciitis. The 2 patients survived with acceptable outcomes and timely healing despite a high chance of mortality and likely amputation secondary to the extensive surface area and anatomical location of the infection.

Advances in Soft Tissue Injuries Associated with Open Fractures.

Management of soft tissue injury is a key component in the overall treatment of upper extremity fractures. Hand surgeons must rely on their armamentarium for treating soft tissue deficits for functional outcomes. Understanding the role of fracture fixation and wound adjuncts, including negative pressure wound therapy and dermal regenerative templates, is the keys to success. In addition, detailed knowledge of local and free tissue options is essential for hand reconstruction.

Delayed skin grafting protocol following Integra™ application for non-radiated scalp reconstruction for decreased wound depth and improved contour.

The clinical use of Integra™ has expanded to include scalp reconstruction since its FDA approval in 1996. Integra™, or dermal regeneration template, can be utilized in patients who are elderly with multiple medical comorbidities. Well-established Integra™ techniques utilize skin grafting 1-2 weeks following evidence of template vascularity. Most studies show the time to graft placement as <30 days, with almost all <52 days. No single article proposes a time frame for applying STSG after neodermis regeneration. Therefore, we aimed to describe our protocol to define a time frame for delaying scalp reconstruction with STSG following dermal regeneration. Over the last several years, the senior author has utilized a delayed reconstruction with skin grafting method where-in Integra™ is applied to either debrided bone or exposed pericranium in selected patients, and allowed to mature for ~6 weeks before performing skin grafting. The results have been predictable, reproducible, and have yielded high levels of patient and provider satisfaction due to the improved contour cosmesis. In this pictorial essay, the authors' novel protocol is detailed.

219 Post-Skin Cancer Scalp Defect Reconstruction with Integra® as Single Stage Surgery: A Case Series

Abstract Aim Large post-surgical scalp defects represent a common challenge in skin cancer surgery reconstruction. Despite the multiple options available the patients, often elderly, may prefer to have the least amount of surgery done and/or have comorbidities that may impair adequate wound healing. In order to reduce the number of hospital appointments and the risks of COVID19 exposure for the frail patients we used Integra®, a very versatile Dermal Regeneration Template for the treatment of skin defects. Originally, Integra® was designed to be followed by a second-stage surgery with a full thickness skin graft (FTSG). We retrospectively collected, in our busy OMFS Unit, a 40-case series of post-skin cancer scalp defects reconstructed using Integra® as single-stage approach without any further surgery. Method We have carried out a literature review of its use on the scalp and examined a series of parameters from our experience including:defect sizedressing appointments and total healing timeanticoagulation, peri-operative antibiotics prescribingcomplications Results The total healing time for the scalp wounds treated with Integra® averages 3.8 months, requiring 7.8 hospital appointments for dressings and checkups. Two infections, 3 significant bleeds and 4 failures were reported. Conclusions The Integra® is a valid and optimal substitute for local flaps and FTSG in patients that may prefer a single-staged approach wishing to avoid a second surgical site and minimising hospital attendance. The drawbacks are the longer time to heal compared to flaps/FTSG, the costs and the risk of delaying radiotherapy if complete epithelialisation is not achieved.

The use of Integra Dermal Regeneration Template in the surgical management of revision penile inversion vaginoplasty: A case series

Since its initial design and use for the temporary coverage of severe full-thickness burn defects, Integra® (Integra LifeSciences) Dermal Regeneration Template has been increasingly used all over the body, yielding successful results in coverage of wound beds with insufficient vascularity and suboptimal conditions for proper healing. In this study, we report an institutional case series and outcomes of gender-affirming vaginoplasty revision for vaginal lengthening or reopening of the canal via placement of Integra® to assist in optimizing the wound bed for subsequent skin grafting when wound conditions were deemed to be suboptimal. A retrospective chart review was conducted in patients who underwent this technique by a single surgeon (JM) at the authors' institution. Demographics, vaginal depth, and complications were recorded and compared. Our patient population thus far includes 178 primary vaginoplasties, of which 9 of those needing revision were treated with this approach. The age at revision mean was 47±13.5 years, and the body mass index mean was 31±4.1. All patients had comorbidities and five were former smokers. Eight patients had prior revision conducted without Integra®, with a mean of 1.89±1.76 and the time to first revision mean was 15.89±14.2 months. No long-term complications after Integra® reported and most of the patients did not require further revision. The follow-up mean was 8.48±8.66 months. A mean of 6.77±5.35cm was gained after the Integra® revision (4.92±4.1cm before versus 12.54±3.07cm after). The final depth after Integra® + full-thickness skin graft mean was 13.34±4.65cm. Overall, the depth gain mean was 7.48±5.77cm; in total, seven patients gained depth after revision with an average of 78% skin graft take. Overall, Integra® presents an alternative option for revision vaginoplasty with complicated wound beds potentially aiding in the healing process before grafting.

Successful reconstruction of full-thickness skin defects in a swine model using simultaneous split-thickness skin grafting and composite collagen microstructured dermal scaffolds.

Reconstitution of normal skin anatomy after full-thickness skin loss may be accomplished using a combination of a dermal regeneration template (DRT) and a split thickness skin graft (STSG). However, because of the relatively low rate of cell infiltration and vascularisation of currently available DRTs, reconstruction is almost always performed in a two-step procedure over the course of several weeks, resulting in multiple dressing changes, prolonged immobilisation and increased chance of infection. To mitigate the potential complications of this prolonged process, the collagen-based dermal template DermiSphere™ was developed and tested in a single-step procedure wherein DermiSphere and STSG were implanted simultaneously. When evaluated in a porcine, full thickness, excisional wound model, DermiSphere successfully supported simultaneous split thickness skin graft take and induced functional neodermal tissue deposition. When compared to a market leading product Integra Bilayer Wound Matrix, which was used in a multistep procedure (STSG placed 14 days after product implantation according to the product IFU), DermiSphere induced a similar moderate and transient inflammatory response that produced similar neodermal tissue maturity, thickness and vascularity, despite being implanted in a single surgical procedure leading to wound closure 2 weeks earlier. These data suggest that DermiSphere may be implanted in a single-step procedure with an STSG, which would significantly shorten the time course required for the reconstruction of both dermal and epidermal components of skin after full thickness loss.

Cultured Skin Autograft in Subtotal Pediatric Scalp Avulsion.

Pediatric scalp avulsions represent a reconstructive challenge because of the unique features of scalp tissue. When microsurgical reimplantation is not feasible, alternative approaches such as skin grafting, free flap transfer with latissimus flap, or tissue expansion are considered. Generally, there is no consensus regarding management of this trauma, and, oftentimes, multiple reconstructive techniques may be needed for definitive coverage. This case study describes the reconstruction of a pediatric subtotal scalp avulsion using a dermal regeneration template and novel autologous homologous skin construct. This case was complicated by the absence of original tissue for reimplantation, excessive size of the defect relative to body habitus, and family concerns for future hair-bearing function. The reconstruction successfully provided definitive coverage and significantly reduced the size of the donor site and associated compilations. However, the hair-bearing potential of the tissue has yet to be determined.

Long-term scarring outcomes and safety of patients treated with NovoSorbⓇ Biodegradable Temporizing Matrix (BTM): An observational cohort study

Background/AimNovoSorbⓇ Biodegradable Temporizing Matrix (BTM) is a relatively novel, biodegradable polyurethane-based dermal regeneration template. The aim of this study was to evaluate the long-term scarring outcomes and safety of BTM in patients who underwent dermal reconstruction involving ≥5% of the total body surface area. MethodsThis was a postmarket, multicenter, observational cohort study involving evaluation of long-term outcomes in patients treated with BTM. A total of 55 patients (35 from Royal Adelaide Hospital, South Australia, and 20 from Victoria Adult Burns Service, The Alfred, Victoria) who underwent dermal repair with BTM between 2011 and 2017 were screened for inclusion in this study. All patients had BTM implanted for ≥18 months. ResultsFifteen eligible patients with a mean (SD) age of 49.1 (14.3) years completed study assessments. These patients had a total of 39 areas treated with BTM. Using the Patient and Observer Scar Assessment Scale, scar quality was reported to be good by both observers and patients, with a mean (SD) observer score across all lesions of 3.6 (1.2) and mean (SD) overall opinion of 3.8 (1.2) as well as a mean (SD) patient score of 3.5 (1.2) and overall opinion of 5.0 (2.2). No adverse events or adverse device effects were reported or identified. ConclusionThe long-term scar quality is comparable to published studies. BTM is safe in the long term with no additional risks or adverse consequences being identified.

Integra® Dermal Regeneration Template: From Design to Clinical Use.

Integra® Dermal Regeneration Template (IDRT, Integra LifeSciences, Princeton, NJ, USA) is a bilayer membrane developed, by Yannas and Burke in the 1980s, to fulfill the unmet need of surgeons having a readily available off-the-shelf dermal regeneration method. IDRT is composed of a sheet of porous cross-linked type I collagen and glycosaminoglycans, with a semi-permeable silicone sheet cover. IDRT is bio-engineered, from adult bovine Achilles tendons and chondroitin-6-sulfate derived from shark cartilage, in a multi-step process involving cross-linking using glutaraldehyde. By design, the composition, porosity, and biodegradation rate of IDRT guides the mechanism of wound repair towards a regenerative pathway. Its mechanism of action involves four distinct phases: imbibition, fibroblast migration, neovascularization, and remodeling/maturation. Originally developed for the post-excisional treatment of deep-partial to full-thickness burns where autograft is limited, over the years its use has expanded to reconstructive surgery.

Review of Orthoplastic Techniques for Lower Extremity Reconstruction: Part One

Orthoplastic techniques are effective tools for limb salvage in the lower extremity. In order to apply proper techniques successfully, a surgeon must be aware of all the different types of flaps available. Proper pre-operative evaluation and patient selection are also important factors. The following review covers six papers that give surgeons a strong foundation in the anatomical basis and surgical technique of intrinsic muscle flaps and other fasciocutaneous or adipofascial flaps of the foot. These flaps, along with split thickness skin grafts, external fixation, and dermal regenerative templates, quickly close soft tissue deficits in the foot and ankle that often lead to infection and amputation. Successfully treating soft tissue defects of the foot and ankle extend life, preserve limbs, and increase function for patients.

Dermal Regeneration Template: Reconstruction in Oral Cancer Defects

BackgroundPost ablative oral mucosal defect resulting from the removal of tumors can be treated with various techniques.PurposeIn this paper, we are showing what, in our experience, are the advantages and disadvantages given using biosynthetic skin substitutes when dealing with this kind of lesions.Materials and methodsPatients included in the sample came to our attention with both neoplastic lesions (11 subjects) and important scar retraction after previous oncologic surgery (1 subject). All patients underwent trans-oral resection surgery following the same surgical protocol and post ablative oral mucosal defect were treated using the dermal regeneration template. The surgical defect location, size, and time of removal of the silicone layer varied from one subject to the other.ResultsMost patients showed good healing with reduced scarring and adequate remucosalisation of the defect. The main complications were shown in a palatal lesion treated with concomitant osteal resection, which developed an oroantral fistula at follow up, and tongue lesions which showed some scarring.ConclusionsGiven our experience, we would advise using dermal substitutes when reconstructing oral defects only after a cautious evaluation of the area of the lesion, the gap size, the possible adherence of the membrane to the gap, and the presence of tissue supporting the overlying membrane.

Post-Treatment Infection in Severe Burn Patients: A Comparative Review on Dermal Matrices

Artificial dermal regeneration templates have been widely used in burn reconstruction surgery, and this allows subsequent skin graft to be taken more successfully. However, many clinical studies have noted instances of infection when testing the effectiveness of a specific template. This review aims to compare two common dermal regeneration templates that are very different in nature -- NovosorbÒ Biodegradable Temporising Matrix (BTM) and IntegraÒ Dermal Regeneration Template. Extensive literature search was conducted, and infection rates associated with each template were recorded. Based on the articles included, Integra has shown to be a more effective method and has resulted in lower infection rates. While current studies have begun to examine the use of dermal regeneration templates in additional settings, more long-term evaluations should be included in the future since wound contracture is a continuous process.

The Bridging Effect of Artificial Dermis on Reconstruction of Skin Avulsion Injury.

Skin avulsion wounds are expected to be swollen and tense after trauma, and skin perfusion can be compromised after primary closure, resulting in wound dehiscence and poor healing. The artificial dermis (AD) serves as a dermal regeneration template that is used to heal skin defects with secondary intention. Therefore, the aim of this study is to evaluate the effect of AD application on traumatic skin avulsion injuries compared to conventional primary closure. A retrospective cohort of 20 patients with skin avulsion injuries were included the study: ten patients were treated with AD and ten patients were managed with primary closure. When compared to the primary closure group, AD group had a shorter average healing time (58.40 ± 26.94 days V 65.50 ± 46.45 days) and significantly higher flap viability (92.00 ± 13.17% V 78.00 ± 13.98%; p = .03). In conclusion, AD is a promising material for the treatment of skin avulsion injury and produces better clinical results.

Retrospective Evaluation of the Use of a Dermal Substitute in Septorhinoplasty

At the present time, various methods exist for camouflaging the dorsum of the nose in septorhinoplasty. The subject of this paper is a retrospective descriptive evaluation of the surgical use of the bovine collagen/glycosaminoglycan matrix Integra Dermal Regeneration Template Single Layer Thin (IDRT-SL Thin) developed by Integra LifeSciences in septorhinoplasty procedures. The focus of this work is to evaluate the postoperative tolerability, the safety, and the course of wound healing when IDRT-SL Thin is applied as a collagen sheet in septorhinoplasty. The evaluation was performed using an evaluation form that was developed for this paper. Patients included in the study were followed up for one year postoperatively; however, the postoperative observation period considered in the evaluation was 14 weeks. The analysis of the surgical results shows relatively homogeneous results for the criteria and time period we examined. No notable complications were observed within the patient cohort up to the 14th postoperative week. Despite the limiting factors within the study due to the lack of a control group undergoing other surgical treatment procedures and the small number of patient cases, the observation period of six and 14 weeks applied in this study is suitable to determine the suitability and tolerability in principle. The results presented in this study can therefore be understood as a possible starting point for further investigations on the use of IDRT-SL Thin in septorhinoplasty.

Characterization of Hydroxyapatite/Chitosan Composite Coating Obtained from Crab Shells on Low-Modulus Ti–25Nb–8Sn Alloy through Hydrothermal Treatment

In this study, hydroxyapatite/chitosan (HA/CS) composite coatings were prepared by hydrothermal treatment on the surface of low-modulus Ti–25Nb–8Sn alloy to improve the surface bioactivity of the alloy. HA, the main mineral composition of the human skeleton, has excellent bioactivity and is often used as a surface coating on biometal implants. CS, a natural polymer with good antibacterial, hydrophilic and non-toxic characteristics, is often used as dermal regeneration templates, hemostatic agents and drug delivery systems. In this experiment, a natural crab shell was used as a raw material to prepare the HA/CS composite coating by alkali treatment and hydrothermal reaction at various temperatures. The microstructure, morphology and phase composition of the coating surfaces were analyzed by XRD, SEM, and FTIR, and the sample coated with HA/CS was soaked in simulated body fluid (SBF) to evaluate its bioactivity. The experimental results showed that the HA/CS composite coatings through hydrothermal treatment at various temperatures can be successfully fabricated on the surface of the Ti alloy. HA on the coating surface exhibited mainly spherical particles and contained A- and B-type carbonate. When the hydrothermal temperature was up to 200 °C, the spherical particles were approximately 20–40 nm. An ultrasonic vibration test was used to evaluate the adhesion of the coatings, showing that the CS exhibited significantly improved adhesion capacity to the substrate. After being soaked in SBF for 7 days, apatite was deposited on the entire surfaces of the HA/CS coatings, indicating that the coating possesses excellent bioactivity.

Successful treatment of critical burns on the example of firefighters: case study presentation

Relevance. The profession of a firefighter involves performing tasks in extreme conditions and is associated with an increased risk of occupational injuries. Despite organizational and technological measures aimed to prevent occupational injuries or death, there are frequent cases of traumatic events in the line of duty, including extensive burns. Such cases are often of a group nature and attract significant public attention.Intention. To present a clinical case of successful treatment of two firefighters who got severe burn injuries in the line of duty.Methodology. The surgical tactics and features of the intensive care of two severely burned firefighters with an unfavorable prognosis, according to the common prognostic scales, are described. The first national experience of large-scale (more than 15 % TBSA) application of novel skin equivalents – dermal regeneration templates is discussed.Results and Discussion. Outcomes of injuries in both cases were favorable. It was possible to avoid severe disability of the patients. This result was achieved through the implementation of modern treatment strategy of critical burns, namely multidisciplinary approach from the moment of admission; early aggressive removal of non-viable tissues, which allows interrupting the pathogenetic mechanism of burn disease; active use of temporary substitutes for the skin, including those of biological origin – the so-called skin equivalents; early restoration of the skin with the priority of functionally active areas (hands, neck, large joints); primary reconstructive surgeries, involving the use of complex plastic methods in the acute period иof injury. Being more resource-demanding, early surgical treatment of burns provides not only reduction of hospital stay, but also a decrease in mortality and improvement in the functional outcomes.Conclusion. The experience of treating these patients demonstrates on the high role of the organization of burn care and the use of new technologies. Novel biological skin substitutes help overcome the lack of donor resources, associated with extensive deep burns. Despite the unfavorable prognosis, the complex application of innovative medical technologies not only provided a favorable outcome for injured firefighters with severe burns, but also allowed them to return to service.

A single-stage bilayered skin reconstruction using Glyaderm® as an acellular dermal regeneration template results in improved scar quality: an intra-individual randomized controlled trial

Absence of almost the entire reticular dermal layer is inherent to the use of autologous split-thickness skin grafting (STSG) to close full-thickness wounds, often resulting in hypertrophic scars and contractures. Many dermal substitutes have been developed, but unfortunately most have varying results in terms of cosmetic and/or functional improvement as well as patient satisfaction, in addition to high costs. Bilayered skin reconstruction using the human-derived glycerolized acellular dermis (Glyaderm®) has been reported to result in significantly improved scar quality using a two-step procedure. Unlike the necessary two-step procedure for most commercially available dermal substitutes, in this study we aimed to investigate the use of Glyaderm® in a more cost-effective single-stage engrafting. This is a method which, if autografts are available, is preferred by the majority of surgeons given the reduction in costs, hospitalization time and infection rate. A prospective, randomized, controlled, intra-individual, single-blinded study was performed, investigating the simultaneous application of Glyaderm® and STSG vs. STSG alone in full-thickness burns or comparable deep skin defects. During the acute phase, bacterial load, graft take and time to wound closure were assessed and were the primary outcomes. Aesthetic and functional results (secondary outcomes) were evaluated at 3, 6, 9 and 12months follow-up using subjective and objective scar measurement tools. Biopsies for histological analysis were taken at 3 and 12months. A total of 66 patients representing 82 wound comparisons were included. Graft take (>95%), pain management and healing time were comparable in both groups. At 1year follow-up, the overall Patient and Observer Scar Assessment Scale assessed by the patient was significantly in favour of sites where Glyaderm® was used. Not infrequently, patients attributed this difference to improved skin sensation. Histological analysis showed the presence of a well-formed neodermis, with donor elastin present for up to 12months. A single-stage bilayered reconstruction with Glyaderm® and STSG results in optimal graft take without loss of Glyaderm® nor the overlaying autografts due to infection. The presence of elastin in the neodermis was demonstrated during long-term follow-up in all but one patient, which is a crucial factor contributing to the significantly improved overall scar quality as evaluated by the blinded patients. The trial was registered on clinicaltrials.gov and received the following registration code: NCT01033604.

Microsurgical Strategies after Free Flap Failure in Soft Tissue Reconstruction of the Lower Extremity: A 17-Year Single-Center Experience.

Background: There is no clear consensus on the optimal surgical strategy for providing safe coverage in salvage free flap surgery after total free flap failure. Methods: A retrospective study was conducted to evaluate patients with total failure of the primary free flap in lower extremity reconstruction between 2000 and 2017. Results: In a cohort of 1.016 patients, we identified 43 cases of total flap failure (4.2%). A total of 30 patients received a salvage free flap with a success rate of 83.3% (25/30). One patient received a secondary salvage free flap. Overall limb salvage after primary free flap loss was 83.7% (36/43). Conclusions: Microsurgical management of free flap loss in the lower extremity is challenging and requires a decisive re-evaluation of risk factors and alternative strategies. This should include reconsidering the flap choice with a tendency towards traditional and safe workhorse flaps, a low-threshold switch to different recipient vessels, including arteriovenous (AV) loops, bypasses (especially in case of venous insufficiency) and back-up procedures, such as negative pressure wound therapy or dermal regeneration templates with skin grafting in cases of lower demand and critically ill patients. We derived one suggestion from our previous practice: replacing perforator flaps with axial pattern flaps (“safe workhorses”).

Soft Tissue Reconstruction Strategy of Spontaneous Calcaneal Fracture in a Patient with Diabetic Penetrating Foot Ulcer

Background: Spontaneous pathologic fractures of the calcaneum in diabetic patients are rarely described in the literature. The pathologic fractures following osteomyelitis represent a possibly limb-threatening condition and if associated with a concomitant calcaneal ulcer, they present defiance for the surgeon and furthermore an outstandingly challenging condition to handle. Methods: A 61-year-old diabetic female patient on insulin therapy has been treated for a penetrating foot ulcer. In sequence the following procedures were carried out: Negative pressure wound therapy with instillation and dwell time (NPWTi-d), Negative Pressure Wound Therapy (NPWT), arterial percutaneous angioplasty (PTA), calcanectomy and temporary arthrodesis, application of Dermal Regeneration Template (DRT) and transplantation of microfractured autologous adipose graft (LIPOGEMS®), treatment of residual dehiscence with physical cold plasma (kINPen®MED). Results: The patient completely healed within 20 months and was able to walk without further aids. Conclusion: The authors point to the promptness within the treatment of pathologic calcaneal fractures, whether throughout the usage of technical devices targeting the reduction of the bacterial load and stimulation of healthy tissue, like in NPWTi-d and kINPen®MED. The use of a dermal regeneration template followed by skin grafting enriched with autologous microfractured adipose tissue (LIPOGEMS®), therefore represents today the most advanced regenerative surgical procedures.