Integra Dermal Regeneration Template Research Articles

Use of Integra dermal regeneration template in burn patients: An Italian expert consensus Delphi study

IntroductionBurn injuries pose significant challenges in healthcare, with Integra dermal regeneration template (DRT) emerging as a prominent solution to enhance wound healing and recovery. Although there is no clear consensus on its technical use and application. We convened a panel of 14 burn specialists aiming to provide consensus regarding the application and usage of Integra in managing burn wounds. MethodsPanelists employed a modified Delphi technique to assess agreement and provide feedback on 81 initial statements covering various aspects of Integra DRT application in burn wound care over three subsequent rounds. This study was endorsed by the Italian Society of Burn Surgery (SIUST). ResultsFourteen heads of burn unit departments participated in the Delphi process. At the end of the third round and subsequent discussion on the final statement list, the panel achieved consensus on 24 statements shaping recommendations for Integra application across various aspects, including wound bed preparation, acellular dermal matrix application, definitive coverage, and complication management. ConclusionThe resultant 24 finalized statements from this Italian consensus offer a comprehensive and practical framework for employing Integra DRT in burn patient care. Reflective of specific Italian expertise and practice, these recommendations supplement and refine existing literature, serving as a dynamic guide subject to periodic updates aligned with evolving evidence and experience in the field of burn surgery.

Tropoelastin modulates systemic and local tissue responses to enhance wound healing

Wound healing is facilitated by biomaterials-based grafts and substantially impacted by orchestrated inflammatory responses that are essential to the normal repair process. Tropoelastin (TE) based materials are known to shorten the period for wound repair but the mechanism of anti-inflammatory performance is not known. To explore this, we compared the performance of the gold standard Integra Dermal Regeneration Template (Integra), polyglycerol sebacate (PGS), and TE blended with PGS, in a murine full-thickness cutaneous wound healing study. Systemically, blending with TE favorably increased the F4/80+ macrophage population by day 7 in the spleen and contemporaneously induced elevated plasma levels of anti-inflammatory IL-10. In contrast, the PGS graft without TE prompted prolonged inflammation, as evidenced by splenomegaly and greater splenic granulocyte and monocyte fractions at day 14. Locally, the inclusion of TE in the graft led to increased anti-inflammatory M2 macrophages and CD4+T cells at the wound site, and a rise in Foxp3+ regulatory T cells in the wound bed by day 7. We conclude that the TE-incorporated skin graft delivers a pro-healing environment by modulating systemic and local tissue responses. Statement of significanceTropoelastin (TE) has shown significant benefits in promoting the repair and regeneration of damaged human tissues. In this study, we show that TE promotes an anti-inflammatory environment that facilitates cutaneous wound healing. In a mouse model, we find that inserting a TE-containing material into a full-thickness wound results in defined, pro-healing local and systemic tissue responses. These findings advance our understanding of TE's restorative value in tissue engineering and regenerative medicine, and pave the way for clinical applications.

Upotreba Integra® Dermalne Regenerativne Ploče u rekonstrukciji defekta stopala zaostalog nakon elektrokucije - prikaz slučaja

Introduction: Electrical burn injuries present a major public health issue in industrialized countries, and unlike electrical arc flash burns, they often result in deeper and more extensive injuries, especially in hands and feet. When choosing from the range of reconstructive modalities, prompt coverage of exposed defects is imperative, ensuring a better functional and cosmetic outcome. Patient review: A 26-year-old male was admitted into our facility's Burns Unit following a high-voltage electrical burn injuries sustained on the same day. After several debridement sessions, the left foot was left with a 100 square centimeter dorsal surface defect with the involvement of ankle joint region. The defect was covered using Integra® Dermal Regeneration Template (IDRT) with a 100% success rate both with the template and later split-thickness skin graft (STSG) application. There were no reported perioperative complications, with satisfactory cosmetic and functional results at the 6-month follow-up. Conclusion: IDRT can be considered a good surgical choice for effective defect coverage with satisfactory results. Nevertheless, the final outcome and patient recovery also often depend on a multitude of other factors, such as the defect size and the involvement of underlying structures.

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.

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.

Integra Dermal Regeneration Template in reconstructive surgery for cutaneous tumours: a two-year retrospective review.

Integra Dermal Regeneration Template (IDRT) (Integra LifeSciences, US) is a bioengineered dermal matrix that has been widely used in burn reconstruction since its first description. However, little is reported on its use in oncologic dermatological defects. Our objective was to evaluate reconstruction using IDRT on cutaneous tumour defects. We conducted a two-year retrospective review of patients with skin tumours who had an excision surgery, followed by reconstruction with IDRT, as a mid-step towards a final autograft procedure: a split-thickness skin graft. The records of all patients at a single academic institution were queried from the electronic medical record using data obtained from the operating surgeon. We identified 13 patients with different tumour types and locations. The mean defect size was 105.92cm². The matrix take rate was 92.3% and average postoperative day for definite autograft was 20 days. Patients were followed for a period of up to 12 months. Of the patients, one had exposed bone without periosteum; another patient showed recurrence six months after matrix placement, requiring a new second two-stage IDRT-autograft procedure before radiation therapy. Patients reported complete satisfaction with the cosmetic, functional and oncological results. No cases of infection were encountered. IDRT is a valid option for the reconstruction of oncologic surgical defects of the skin and can be used in different anatomical locations. Specifically, it is an alternative to the reconstructive ladder when grafts and local flaps are not possible in those patients, and an option for patients who will eventually need adjuvant radiotherapy.

Unique way of chest wall reconstruction using Integra Dermal Regeneration Template (IDRT) in a patient with post traumatic mucormycosis: A case report.

Introduction and importanceNecrotizing soft tissue infections (NSTI) are caused by toxin-producing bacteria and fungi that results in rapid progression of disease with significant local tissue destruction.Case presentationWe present a case report of a 57-year-old male patient in line with the SCARE 2020 criteria. He was admitted to the emergency department with a small abrasion on the right antero-lateral chest wall, and a diffuse necrotic patch of skin and soft tissues with purulent discharge.Clinical discussionClinical examination, routine blood investigations, CT scan chest, and chest x-ray were performed. Patient underwent debridement six times, followed by negative pressure wound therapy (NPWT). After negative culture report, Integra Meshed Dermal Regeneration Template (IMDRT), measuring 4 × 5 in. was applied and NPWT continued. The outer layer of IDRT was removed on Day 19. Split thickness skin grafting (STSG) was performed once neodermis formation was confirmed. NPWT was continued post skin grafting for a week. IDRT was successfully taken up over the raw area with exposed lung. Patient was discharged 10 days after STSG. The patient's condition improved remarkably and he was able to breathe normally. There was no puckering or tethering effect on the grafted area and not much fibrosis. He showed speedy recovery with healed donor site and 100% uptake of grafted tissue.ConclusionIDRT along with NPWT is an effective and useful technique for spontaneous regeneration of the dermis and basement membrane to promote wound healing in traumatic patients with NSTIs.Level of evidenceLevel V.Study typeTherapeutic.

Six Year's Experience Application of Dermal Matrix for Vascular Wounds

The purpose of this cross-sectional study is to evaluate the effectiveness of a dermal-epidermal matrix substitute (Integra Dermal Regeneration Template [IDRT]) for vascular wounds. Our primary end point was healing rate and recurrence rate. The secondary end point was comparing healing rate to bone expositions rate, hyperbaric oxygen therapy (HOT) and efficiency. We retrospectively reviewed all medical records of patients treated by IDRT from November 2016 to July 2021 by our team, to evaluate the effects of Integra in wound healing. The inclusion criteria was use of IDRT. We evaluated the ulcer and patient profile, use of hyperbaric therapy, negative-pressure therapy, healing and recurrence. A total of 40 patients were included; the median age was 65.5 years, 21 patients were female (52.5%) and 19 male (47.5%). The etiology of the wound was arterial in 10, mixed in 2, mycroangiopatic/hypertensive in 4, infectious in 4, traumatic in 13, and venous in 7. The global healing rate was 77.5%. Three (7.5%) patients have recently been submitted to the surgical procedure with use of the IDRT and still in follow-up. Thirty-seven (92.5%) used negative-pressure therapy during the treatment, 28 (75.6%) of them had their wounds healed and 9 (24.32%) did not. Eleven ulcers had bone exposure and sixteen had tendon exposure with healing rate of 90.9% and 81,35% respectively. Comorbidities were present in 34 (87,5%), in the most of cases hypertension in 26 (65%), diabetes in 24 (60%), and dyslipidemia in 18 (45%). Twelve (30%) of them needed revascularization before the IDRT and 14 (35%) patients realized HOT after. The HOT group had a healing hate of 92.85%, and no recurrence, in contrast to no-HOP that had respectively 69.23%, and 3.84% (P = .088). The arterial wounds had healing rate of 90% without recurrence and venous wound 71.4% and no recurrence. We had just one recurrence, in the mixed group (recurrence rate 50%). All patients with venous ulcer had yours varicose veins and/or obstructed veins treated and those with peripheral arterial disease were submitted to revascularization. In our experience, the use of IDRT is an important and helpful option in wound care. In addition, HOT may be an useful option in a limb salvage and wound healing program. We noticed a tendency of better healing in those patients in despite the absence statistical significance. The only patient who had recurrence of the ulcer did not follow the clinical treatment prescribed. We observed that the application of negative-pressure therapy could potentially increase the integration of dermal matrix and, could be a first-line treatment option for wounds with bone or tendon exposure.

Closure of large lumbosacral defect using a combined method of bilateral bipedicle flap with lateral releasing incision and Integra® dermal regeneration template

BACKGROUND: Myelomeningocele is one of the most complex congenital malformations of the central nervous system. It is one of the most common types of spina bifida which involves a failure of neural tube closure. Reconstruction surgery for myelomeningocele had always been challenging for plastic and neurosurgeons.
 CLINICAL CASE: We report a case of a new-born with lumbosacral myelomeningocele who received treatment in the Hospital Universiti Sains Malaysia. The myelomeningocele was repaired by the neurosurgery team and subsequently, the child was left with huge lumbosacral skin defect. The large defect was successfully covered by using a combined method of bilateral bipedicle flap with lateral releasing incision and remaining lumbosacral and secondary defect resurfaced using Integra dermal regeneration template (DRT). We used ACTICOAT interfaced negative pressure wound therapy (NPWT) as our main dressing in preparing the wound bed for autologous epidermal graft. The result of our closure technique provides tension free closure.
 DISCUSSION: We incorporated bilateral bipedicle fasciocutaneous flap technique together with DRT for closure of the lumbosacral defect. The bilateral bipedicle flap with lateral releasing incision served to reduce tension on the skin at bilateral lumbar region. The DRT downsized the lumbosacral defect and NPWT dressing provided an optimal sterile environment in giving time for neodermis generation. The remaining secondary defect were also resurfaced utilizing DRT and autologous skin grafting.
 CONCLUSIONS: The outcome of surgery demonstrated that the combined use of bilateral bipedicle fasciocutaneous flap with lateral releasing incision and DRT with delayed skin grafting is safe, effective and provide long term stable and supple scar for large, exposed dura defect.

Nasal reconstruction with one-stage dermal regeneration template and full-thickness skin graft: Long-term patient outcomes and complications

To the Editor: The nose is a common location for skin cancer, with surgical resection being the treatment of choice. However, nasal reconstruction can be challenging due to the unique three-dimensional structure of the nose. A graft is often performed when a simple approach may result in undesirable distortion and when a flap is unfavorable due to prior scars or poor skin quality. In addition to traditional skin grafts, skin substitutes are increasingly being used in reconstructive surgery.1 The Integra dermal regeneration template (Integra; Integra LifeSciences) is a skin substitute that was recently shown to result to favorable aesthetic outcomes following a single-stage method for nasal defect reconstructions.

Dermal Regeneration Templates in Maxillo-Facial District: A Multipurpose Aid.

Since 1980s, the use of dermal regeneration templates (DRT) for reconstructive purposes has been described in Literature.1 The authors present their experience of 13 patients treated with integra dermal regeneration template and a single-stage surgery for different indications like oncologic reconstruction, trauma injuries, and preprosthetic surgery in the maxillo-facial district.The authors retrospectively reviewed a total of 13 patients treated with DRT at Maxillo-Facial Department of S. Maria Hospital in Terni.Inclusion criteria included the presence of a defect nonapproachable primarily or by secondary intention with an easy locoregional flap reconstruction, a complete clinical record, and a minimum 6 months follow-up.A total of 12 patients underwent surgical reconstruction with DRT at the S. Maria Hospital from June 2018 to February 2020.During follow-up, all patients in which intraoral reconstruction was performed showed first signs of re-mucosization and neovascularization after 10 days.Only in 1 patient (8%) a seroma underneath the silicon sheet was observed. Afterward, the patient healed correctly with no other complications.Dermal regeneration template represents an option that should be considered in the head and neck district reconstruction, especially for intraoral defects where, thanks to its long-term functional results and limited alternatives, should represent a relevant choice.

Indications and functional outcome of the use of integra® dermal regeneration template for the management of traumatic soft tissue defects on dorsal hand, fingers and thumb

Few studies have been conducted to explore the utility of the Integra® dermal regeneration template (IDRT) combined with a delayed split-thickness skin graft (STSG) for reconstructing complex dorsal hand, digit, and thumb injuries. This study reports the indications and outcomes for 14 patients treated with this technique via a two-stage process. We retrospectively reviewed all patients treated by IDRT combined with STSG from May 2015 to October 2018. The inclusion criterion was traumatic or post-infectious soft tissue defects (STDs) of the dorsal hand, fingers, and thumb, not suitable for direct wound closure and requiring local, pedicle, or free flap reconstruction. After debridement, a two-stage procedure was applied, namely IDRT followed by STSG. Indications, functional outcomes, aesthetic results, complications, patient satisfaction, and the STSG take rate were evaluated over a 36-month follow-up using standardised instruments. A total of 14 patients with 15 reconstructions (average age = 48years) were included. The dominant hand was involved in 50% of cases. Dorsal STDs involved the hand, fingers, thumb, and hand and thumb in 7, 3, 2 and 2 cases, respectively. The mean STD size was 35cm2 (range: 3-150cm2). The wound was associated with exposed tendons (without peritenon), bone (without periosteum), and joints (without a capsule) in eight cases (57%). The IDRT/STSG take rate was 97%. The average Vancouver Scar Scale score was 2 (1-4). The 36-month follow-up demonstrated that IDRT is a safe and reliable technique that can be considered a viable alternative to flap reconstruction for the management of traumatic STDs in selected patients. The aesthetic outcomes are acceptable, functional recovery of the fingers is excellent, patient satisfaction is very high and the rate of complications is very low.

Adipose Stem Cells and Platelet-Rich Plasma Induce Vascular-Like Structures in a Dermal Regeneration Template.

In the context of biointeractive dressings used for enhancing wound healing, the use of stromal vascular fraction (SVF) or adipose-derived stem cells (ASCs) hereof derived has not been fully exploited yet. Noncultured SVF, a heterogeneous mesenchymal population of cells, is attractive in the field of dermal regeneration because it can be instantaneously obtained, avoids genomic alterations, and is comparatively safer than cultured ASCs. Integra® Dermal Regeneration Template (DRT) was sprinkled with ASCs in complete medium supplemented with 10% fetal bovine serum (FBS), or SVF, obtained from emulsified or nonemulsified fat, in medium supplemented with 2% platelet-rich plasma (PRP). The presence and differentiation of cells were evaluated by standard histochemistry and immunohistochemistry, whereas conditioned media were analyzed for vascular endothelial growth factors (VEGF) by ELISA. In vitro experiments were conducted to analyze ASC proliferation in the presence of either FBS or PRP. Deposition of ASCs in medium supplemented with FBS caused their integration into Integra DRT as early as 1 h. ASCs were found as aggregates until 6-10 days without forming organized structures. When seeded onto Integra DRT, SVF cells in medium supplemented with PRP formed aggregates at early times, which at 7 and 10 days organized into vascular-like structures, lined by CD31+ and smooth muscle actin-positive cells. With nonemulsified fat, the lacunar structures did not show an organized distribution of SVF cells. PRP induced ASC proliferation although at lower level than FBS. VEGF secretion was enhanced when fat emulsification was introduced into the protocol. In conclusion, the combination of SVF cells obtained from emulsified fat, PRP, and Integra DRT exhibit synergistic effect on the formation of vessel-like structures indicating a step forward aimed at regenerative surgery for chronic wound healing.

Three-year experience with Integra dermal regenerative template as a reconstructive tool

Background Since the introduction of Integra dermal regeneration template, several reports have been published worldwide proving its ability as a less invasive reconstructive tool. Our aim is to report our 3-year experience with Integra as the first report from Kuwait. Patients and methods Integra was used for reconstruction of a wide variety of complex wounds in different body locations. The dermal regenerative template replaced soft tissue defect as a first stage followed by skin grafting as a second stage. Forty patients were included with mean age of 40.2±20.7 years, with 24 cases having one or more comorbidities. Twenty-five patients were female and 15 were males. We had 20 cases with exposed underlying structures in wound bed, including bones, tendons, and joints. Results The average engraftment rate of Integra was 97±10.2%. Average time for skin grafting was 20.4±4.8 days and average skin graft take was 95±10.9%. Early complications included a case of Integra infection and another case of hematoma. After skin grafting, there were two cases of partial graft losses that healed without the need for regrafting. Complete wound healing was achieved in all cases within 8 weeks. Mean follow-up period was 16.65±8.4 months. No contracture or recurrent ulceration was documented. Apart from hyperpigmentation, 95% of the patients were satisfied with reconstruction outcome, with normal skin pliability in 95% cases, and normal range of movement in 85% of cases. Conclusion Integra is efficient and safe, with wide range of clinical indications. It has very high engraftment rate even in complex wounds with exposed bone or tendon. We observed high patient satisfaction and excellent pliability and final function.

The Use of Collagen-Glycosaminoglycan Biodegradable Matrix (Integra®) in the Management of Neck Postburn Hypertrophic Scars and Contractures

Glycosaminoglycan (GAG) is a chain-like disaccharide that is linked to a polypeptide core to connect two collagen fibrils/fibers and provide the intermolecular force in a Collagen-GAG matrix which can be a valuable treatment of post-burn contractures and hypertrophic scars, which remain a challenge to reconstructive surgery. The face and neck contractures are the most difficult sites to treat. This article is meant to discuss our clinical experience in using collagen-glycosaminoglycan biodegradable matrix (Integra® Integra Lifesciences Corporation, Plainsboro, NJ, USA) to reconstruct defects created by excision of contracted areas from the neck and lower face areas. Between 2009 and 2011, we had 11 patients that underwent Integra reconstructive procedures. The mean follow-up period was 18 months. For all the patients, the intake of the Integra dermal regeneration template was 100%, even if one patient developed a minor infection treated with appropriate antibiotics. The patients are very satisfied with the result. A minor problem was a small difference in skin color, but this inconvenience was compensated by good skin elasticity.

Use of Integra Dermal Regeneration Template for Limb Salvage in Diabetic Patients With No-Option Critical Limb Ischemia.

We have analyzed in a retrospective study of consecutive diabetic patients affected by no-option critical limb ischemia (CLI) the efficacy of the dermal substitute Integra Dermal Regeneration Template for treatment of complicated foot lesions. The primary end point was limb salvage and 1-year amputation-free survival. The secondary end point was healing time of surgical site. Between October 2014 and October 2017, 1024 patients with diabetic foot ulcer (DFU) and CLI were admitted. In 84 patients (8.2%), there was a failure in distal revascularization with a persistent CLI after the procedure. Despite the persistent CLI, a group of 26 patients of this cohort obtained complete wound healing. Among them, 13 patients were treated with surgical debridement or open amputations and application of dermal substitute Integra Dermal Regeneration Template and the other 13 patients were treated without any dermal substitute. The Integra group healed within a mean time of 83.5 days, and the control group healed within a mean of 139 days (P = .028). No major amputation was carried out at 1-year follow-up in the Integra group versus 15% in the control group. A conservative foot surgery or an approach with minor amputation in diabetic patients with no-option CLI may achieve limb salvage. The use of Integra Dermal Regeneration Template in patients with DFU and no-option CLI may be a useful option in a limb salvage program.

The Basics of Integra Dermal Regeneration Template and its Expanding Clinical Applications.

First developed for coverage of burn wounds, Integra (Integra LifeSciences) is a synthetic acellular dermal regeneration template that provides a base for revascularization and neodermal formation. The use of Integra has slowly grown and has now become an important consideration along the reconstructive ladder. This article reviews the basic science of Integra and provides an overview of the many expanding applications based on anatomic location.

Design of an elastin-layered dermal regeneration template.

The scars of full thickness wounds typically lack elasticity. Elastin is essential for skin elasticity and is enriched in the deep dermis. This paper is significant because it shows that: (1) we can generate elastic fibers in tunable quantities, (2) tropoelastin is the rate-limiting component in elastin synthesis in vitro, (3) we can generate elastin fibers regardless of donor age, (4) we describe a novel approach to further increase the numbers and thickness of elastic fibers for older donors, (5) we improve on Integra Dermal Regeneration Template and generate a new hybrid biomaterial intended to subsequently surgically deliver these elastic fibers, (6) the elastic fiber layer is presented on the side of Integra that is intended for delivery into its physiologically appropriate site i.e. the deep dermis.

USE OF ACELLULAR DERMAL MATRICES IN THE TREATMENT OF TROPHIC ULCERS OF THE LOWER LIMBS

Introduction. The paper describes the experience with acellular dermal matrices (ADM) used in patients with trophic ulcers (TU) and their comparative analysis with traditional autodermoplasty (ADP) on granulation. Subjects and methods. The early (10–14-day) and late (over a year) results were analyzed in 8 TU patients aged 25–55 years who used ADM – Integra Dermal Regeneration Template (IDRT) (INTEGRA Life Sciences Corporation, USA). All the patients with TU met the following criteria: an area of 25 to 150 cm2; a proliferative phase of the wound process; a defect duration of more than 12 months (during medical treatment). The patients were divided into 2 groups: 1) 5 female patients used IDRT (a two-layer variant); 2) 3 patients (2 women and 1 man) had IDRTSL (a one-layer variant). A comparison group consisted of 5 patients (3 women and 2 men) who underwent ADP on granulation without ADM. The patients were assessed by age, sex, TU site, extent, and etiology, disease duration, previous treatment, and the presence of comorbidities. Results. On days 10–14, the mean autodermal graft retention rate in Groups 1 and 2 was 72.0 and 66.7 %, respectively, whereas that in the comparison group was 75 %. The shortest length of hospital stay was observed in the comparison group. However, within a year, 4 (80 %) of the 5 patients in this group were unsatisfied with the results of treatment, which was associated with recurrent TU or the development of hypertrophic ulcer. No recurrences were noted in the study groups (Groups 1 and 2). All the 8 (100 %) patients confirmed that the proposed treatment option met their expectations and reported their better quality of life.

A clinical trial of Integra Template for diabetic foot ulcer treatment.

Individuals with diabetes mellitus are at an increased risk of developing a diabetic foot ulcer (DFU). This study evaluated the safety and efficacy of Integra Dermal Regeneration Template (IDRT) for the treatment of nonhealing DFUs. The Foot Ulcer New Dermal Replacement Study was a multicenter, randomized, controlled, parallel group clinical trial conducted under an Investigational Device Exemption. Thirty-two sites enrolled and randomized 307 subjects with at least one DFU. Consented patients were entered into the 14-day run-in phase where they were treated with the standard of care (0.9% sodium chloride gel) plus a secondary dressing and an offloading/protective device. Patients with less than 30% reepithelialization of the study ulcer after the run-in phase were randomized into the treatment phase. The subjects were randomized to the control treatment group (0.9% sodium chloride gel; n = 153) or the active treatment group (IDRT, n = 154). The treatment phase was 16 weeks or until confirmation of complete wound closure (100% reepithelialization of the wound surface), whichever occurred first. Following the treatment phase, all subjects were followed for 12 weeks. Complete DFU closure during the treatment phase was significantly greater with IDRT treatment (51%) than control treatment (32%; p = 0.001) at sixteen weeks. The median time to complete DFU closure was 43 days for IDRT subjects and 78 days for control subjects in wounds that healed. The rate of wound size reduction was 7.2% per week for IDRT subjects vs. 4.8% per week for control subjects (p = 0.012). For the treatment of chronic DFUs, IDRT treatment decreased the time to complete wound closure, increased the rate of wound closure, improved components of quality of life and had less adverse events compared with the standard of care treatment. IDRT could greatly enhance the treatment of nonhealing DFUs.