BACKGROUND: A phase 3b, open-label, multicenter, expanded-access study (NCT04123548) evaluated safety and clinical outcomes of StrataGraft treatment in adults with deep partial-thickness thermal burns with intact dermal elements.
METHODS: Adult patients with 3 % to < 50 % total body surface area burns were treated with a single application of ≤ 1:1 meshed StrataGraft and followed for 24 weeks. Primary endpoint was count and percentage of patients with treatment-emergent adverse events (TEAEs). Secondary endpoints included confirmed wound closure (WC) at Week 12, durable WC at Week 24, time to WC, scar evaluation, and wound infection-related events.
RESULTS: Fifty-two patients with 96 treatment sites were enrolled. Pruritus was the most common TEAE (22 patients [42.3 %]). Twenty serious TEAEs occurred in 10 patients (19.2 %); none were related to StrataGraft. There were 4 (7.7 %) deaths (aspiration, myocardial infarction, self-injury, Gram-negative rod sepsis); none were related to StrataGraft. Confirmed WC was achieved by Week 12 in 33 patients (63.5 %; 95 % CI: 50.4-76.5 %) and 69 treatment sites (71.9 %; 95 % CI: 62.9-80.9 %). Durable WC was achieved by Week 24 in 29 patients (55.8 %; 95 % CI: 42.3-69.3 %) and 58 treatment sites (60.4 %; 95 % CI: 50.6-70.2 %).
CONCLUSIONS: StrataGraft demonstrated clinical benefit. Safety data were consistent with previously reported findings.

BACKGROUND: Iliac crest autograft is frequently used to fill in bone defects after osteotomies. Nonetheless, surgery for bone autograft procurement is associated with morbidity and pain at the donor site. Alternatives to it have been explored, but there is no consensus to guide their application as a routine practice in several orthopedic procedures. Thus, this study was designed to compare the efficacy and safety between iliac crest autograft and allograft in medial opening wedge high tibial osteotomy.
METHODS: Forty-seven patients with a symptomatic unilateral genu varum and an indication for high tibial osteotomy were randomly assigned to receive either autograft or allograft to fill the osteotomy site. Operative time, bone healing, and complication rates (delayed union, nonunion, superficial and deep infection, loss of correction, and hardware failure) were recorded after a one-year follow-up. Data were expressed as Mean ± Standard Deviation and considered statistically significant when p < 0.05.
RESULTS: The time to radiologic union was similar between both groups (Allograft: 2.38 ± 0.97 months vs. Autograft: 2.45 ± 0.91 months; p = 0.79). Complication rates were also similar in both groups, with one infection in the allograft group and two in the autograft group, two delayed unions in the allograft group, and three in the autograft group. The operative time differed by 11 min between the groups, being lower in the allograft group (Allograft: 65.4 ± 15.1 min vs. Autograft: 76.3 ± 15.2 min; p = 0.02).
CONCLUSIONS: Iliac crest allografts can be safely and effectively used in medial opening wedge high tibial osteotomy as it promotes the same rates of bone union as those achieved by autologous grafts, with the benefits of a shorter operative time.
BACKGROUND: U1111-1280-0637 1 December 2022, retrospectively registered.

BACKGROUND: Neurosurgical interventions and trauma are common causes of damage to the optic nerve. This determines the relevance of research for solutions aimed at restoration of the nerve\'s anatomical integrity, electrical conductivity, and subsequently - restoration of its function. Restore a damaged (cut) optic nerve using n. suralis autograft in vivo.
METHODS: The experiment involved reconstruction of the optic nerve through injury modulation, graft placement and restored nerve harvest and evaluation. Injury modulation included removal of a fragment of the optic nerve. Autograft harvesting and placement involved resection of a fragment of the sural (sensory) nerve and its subsequent anastomosis in place of the removed fragment of the optic nerve. As an experimental model, a rabbit of the \"Burgundy\" breed was used. The animal was previously examined for the presence of infectious and other diseases to confirm its health.
RESULTS: Four months post operatively when stimulating the operated right eye, low-amplitude components altered in shape are registered. Thus, signs of mild restoration of electrical conductivity on the treated optic nerve were seen.
CONCLUSIONS: Our initial experience shows the technical feasibility of reconstructing the optic nerve using an autograft, the possibility of axonal growth through the graft and, in the future, using this method for direct optic nerve reconstruction, as well as a bypass method for damage to the optic nerve with various tumor diseases of the optic nerve, tumors of the chiasmatic-sellar localization, orbital injuries.

UNASSIGNED: To investigate whether interference screw fixation through an anteromedial portal into an outside-in drilled femoral tunnel via a flip cutter results in acceptable hardware position.
UNASSIGNED: 10 cadaveric knees underwent ACL-reconstruction with patellar BTB autograft. Femoral tunnel drilling was performed utilizing an outside-in flip cutter drill and interference screws for femoral fixation. Lateral and anterior-posterior (AP) fluoroscopic images were taken to measure screw divergence within the femoral tunnel. The means of AP and lateral divergence angles were compared using two-tailed t-tests.
UNASSIGNED: Using the flip cutter, the AP and lateral divergence angles were 7.3° ± 4.5° and 9.3° ± 9.3°, respectively, while the total divergence angles were 16.6° ± 11.8°. Divergence angles using a cannulated reamer were found to be 14.4° ± 2.5° and 6.8° ± 2.8° for AP and lateral, respectively and 21.1° ± 5.2° for the total divergence. The AP divergence angles using the flip cutter were significantly less than those reported using a cannulated reamer (p = 0.001).
UNASSIGNED: The flip cutter method resulted in significantly reduced divergence angle between the screw and graft when compared to previous cadaveric studies in the coronal plane. There was no significant difference in divergence angle in the sagittal plane. Both methods appear to result in divergence angles below the threshold which would be considered to significantly decrease pull-out strength. Large standard deviations also reflect limited sample size but may also suggest more variability in divergence when compared to historical control set. This study clearly establishes the outside-in technique using a retrograde reamer as a viable independent femoral drilling solution for ACL reconstruction when using a BTB autograft with a femoral interference screw.

BACKGROUND: Cartilage is an important source in supporting the structure of the nose for dorsal augmentation rhinoplasty. However, it is known that its viability is not always on the ideal level. Various wrapping materials are used to increase the strength of cartilage. Donor site morbidity, which develops following the harvesting of both cartilage and fascia as one such cover material, has attracted interest in recent years.
OBJECTIVE: In this study, we aimed to investigate the potential of dermis and tendon autografts as alternatives to fascia and cartilage.
METHODS: The sample of the study included 16 New Zealand white rabbits. The right auricular cartilage of all rabbits was amputated, and it was transformed into diced cartilage autografts. The dermis autografts from the right gluteal areas of the rabbits were deepithelialized, and lumbosacral fascia autografts were harvested from the same incision. Additionally, the Achilles tendon of each rabbit was harvested and transformed into diced tendon autografts. Four different autografts were embedded under the skin of each rabbit from 4 different pouches opened in the back of the rabbit. These autografts included diced cartilage alone (Intervention 1), fascia-wrapped cartilage (Intervention 2), dermis-wrapped cartilage (Intervention 3) and fascia-wrapped tendon (Intervention 4) autografts.
RESULTS: Intervention 1 had the most irregular appearance, the outcomes in Intervention 4 were volumetrically smaller and softer. Connective tissue formed between the diced pieces in all interventions, and it was observed that the dermis and fascia had a capsule-like appearance, and their viability was preserved. The differences between the initial and final measurements of the volumes of interventions 1, 2 and 3 were statistically significant (p < 0.05). There was no significant difference between the initial and final volumetric measurements of intervention 4 (p > 0.05). More peripheral proliferation was observed in the interventions of fascia-wrapped and dermis-wrapped diced cartilage compared to the other interventions. The intervention including fascia-wrapped diced tendon grafts had displayed more fibrosis, fragmentation and collagen fibers, while it showed a lower amount of elastic fiber. There were no significant differences among the intervention in terms of other histological parameters.
CONCLUSIONS: Tendon autografts may be a good option for dorsal augmentation rhinoplasty as they are easily harvested and have minimal donor site morbidity. Dermis autograft usage is more advantageous than fascia usage in terms of accessibility and convenience.
METHODS: This journal requires that authors assign a level of evidence to each submission to which Evidence-Based Medicine rankings are applicable. This excludes Review Articles, Book Reviews and manuscripts that concern Basic Science, Animal Studies, Cadaver Studies and Experimental Studies. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

A postextraction socket becomes a clinical challenge due to the fact that a series of changes associated with bone remodelling and resorption of the socket that occur after extraction, which limits the aesthetic and functional prognosis of implant-supported rehabilitations. It has been studied that the use of the autologous tooth-derived graft (ATDG) has regenerative properties and could therefore be useful for solving this type of problem. There is no consensus in the scientific literature on a standardized protocol for the use of the autologous tooth. Therefore, the aim of the present study was to evaluate the most relevant parameters to achieve the best properties of ground ATDG using three methods, namely Gouge forceps, electric grinder, and manual, that made up the study group (SG) and compared with the control group (CG) consisting of Bio-Oss®. The sample obtained by the electric grinder had the highest value of specific surface area (2.4025 ± 0.0218 m2/g), while the particle size as average diameter (751.9 µm) was the lowest and most homogeneous of the three groups. Therefore, the electric grinder allowed for obtaining ATDG with more regenerative properties due to its specific surface-area value and particle size in accordance with the xenograft with the greatest bibliographical support (Bio-Oss®). The higher specific surface increases the reaction with the physiological media, producing faster biological mechanisms.

UNASSIGNED: In bone sarcomas, chemotherapy has improved the prognosis with advances in diagnostic and surgical technologies, which has led to attempts to save limbs. As early detection and multidisciplinary treatment have improved the survival rate, curative surgery is considered for selected patients with metastatic bone carcinomas. Limb salvage procedures may vary in relation to the reconstruction method, which is accompanied by different complications. To overcome them, we devised a novel concept, in-situ local tumor ablation and recycling machine based on radiofrequency (RF)-induced heating and intended experiments to demonstrate its feasibility.
UNASSIGNED: The fresh femurs of 6-month-old pigs were used after removing the epiphyses; the distal parts were placed in a heating chamber. Fiber-optic temperature sensors were inserted in the metaphysis, meta-diaphysis, and diaphysis. Temperatures were measured six times each during heating at 27.12 MHz at various powers. Additionally, the compressive and bending stiffnesses were measured six times each for the unprocessed, RF-treated, and pasteurized bones, and the results were compared.
UNASSIGNED: Under 200 W power output, the temperatures at all measurement sites reached 70 ℃ or higher in 6 minutes, and the temperatures were maintained. The median compressive stiffness of RF-heated bones was 79.2% higher than that of pasteurized bones, but the difference was statistically insignificant. The median bending stiffness of RF-heated bones was approximately 66.3% of that of unprocessed bones, which was 20% higher than that of pasteurized bones.
UNASSIGNED: The feasibility to rapidly attain and maintain temperatures for tumor ablation is shown, which favorably preserves bone stiffness through the in-situ local tumor ablation and recycling based on RF heating. The problem of nonuniform temperature distribution might be solved by an optimal design determined from simulation research and additional experiments.

BACKGROUND: Biphasic calcium phosphates (BCP) may serve as off-the-shelf alternatives for iliac crest-derived autologous bone in alveolar cleft reconstructions. To add osteoinductivity to the osteoconductive BCPs to achieve similar regenerative capacity as autologous bone, a locally harvested buccal fat pad will be mechanically fractionated to generate microfragmented fat (MFAT), which has been shown to have high regenerative capacity due to high pericyte and mesenchymal stem cell content and a preserved perivascular niche.
OBJECTIVE: Our primary objectives will be to assess the feasibility and safety of the BCP-MFAT combination. The secondary objective will be efficacy, which will be evaluated using radiographic imaging and histological and histomorphometric evaluation of biopsies taken 6 months postoperatively, concomitant with dental implant placement.
METHODS: Eight patients with alveolar cleft (≥15 years) will be included in this prospective, nonblinded, first-in-human clinical study. MFAT will be prepared intraoperatively from the patient\'s own buccal fat pad. Regular blood tests and physical examinations will be conducted, and any adverse events (AEs) or serious EAs (SAEs) will be meticulously recorded. Radiographic imaging will be performed prior to surgery and at regular intervals after reconstruction of the alveolar cleft with the BCP-MFAT combination. Biopsies obtained after 6 months with a trephine drill used to prepare the implantation site will be assessed with histological and histomorphometric analyses after methylmethacrylate embedding and sectioning.
RESULTS: The primary outcome parameter will be safety after 6 months\' follow-up, as monitored closely using possible occurrences of SAEs based on radiographic imaging, blood tests, and physical examinations. For efficacy, radiographic imaging will be used for clinical grading of the bone construct using the Bergland scale. In addition, bone parameters such as bone volume, osteoid volume, graft volume, and number of osteoclasts will be histomorphometrically quantified. Recruitment started in November 2019, and the trial is currently in the follow-up stage. This protocol\'s current version is 1.0, dated September 15, 2019.
CONCLUSIONS: In this first-in-human study, not only safety but also the histologically and radiographically assessed regenerative potential of the BCP-MFAT combination will be evaluated in an alveolar cleft model. When an SAE occurs, it will be concluded that the BCP-MFAT combination is not yet safe in the current setting. Regarding AEs, if they do not occur at a higher frequency than that in patients treated with standard care (autologous bone) or can be resolved by noninvasive conventional methods (eg, with analgesics or antibiotics), the BCP-MFAT combination will be considered safe. In all other cases, the BCP-MFAT combination will not yet be considered safe.
BACKGROUND: Indonesia Clinical Trial Registry INA-EW74C1N; https://tinyurl.com/28tnrr64.
UNASSIGNED: DERR1-10.2196/42371.

UNASSIGNED: This study aimed to evaluate the effect of using an inferior or superior conjunctival autograft in primary pterygium surgery on the postoperative ocular surface.
UNASSIGNED: Forty eyes of 40 patients who underwent pterygium surgery with autograft were included in the study. Cytological cell counts were performed on samples taken from the bulbar conjunctiva by impression cytology before and 1 year after the operation. Schirmer 1 test score, lissamine green conjunctival staining score, tear film break-up time (TBUT), and fluorescein corneal staining scores were evaluated. The pain levels of the patients were evaluated with visual analog scale at postoperative 1 day and 1 week.
UNASSIGNED: Corneal and conjunctival staining, TBUT, and Schirmer test results demonstrated significant improvement in all patient groups after surgery, but there was no difference between groups (p>0.05). In both preoperative and postoperative impression cytology, the number of goblet cells in the inferior bulbar conjunctiva was higher than in the superior bulbar conjunctiva (p<0.001), while there was no such difference in epithelial cell or mucin staining. There were no significant cytological changes postoperatively in either group (p>0.05).
UNASSIGNED: Pterygium surgery with autografting improved tear function tests regardless of graft location. Goblet cell count was higher in the inferior bulbar conjunctiva than in the superior bulbar conjunctiva in both postoperative and preoperative impression cytology. However, there was no significant difference in postoperative epithelial and goblet cell counts or mucin staining between the groups before and after surgery. We think that using the inferior bulbar conjunctiva is an appropriate choice in cases where the superior conjunctiva cannot be used as a graft or when future glaucoma surgery is possible.

UNASSIGNED: This study compared the effect of various grafting materials on the area and volume of minerals attached to dental implants.
UNASSIGNED: In this animal study, 13 dogs were divided into three groups according to the time of sacrificing (2 months, 4 months, or 6 months). The implants were placed in oversized osteotomies, and the residual defects were filled with autograft, bovine bone graft (Cerabone), or a synthetic substitute (Osteon II). At the designated intervals, the dogs were sacrificed and the segmented implants underwent micro-computed tomography analysis. The bone-implant area (BIA) and bone-implant volume (BIV) of bone and graft material were calculated in the region of interest around the implant. The data were analyzed by two-way analysis of variance (ANOVA) at P < 0.05.
UNASSIGNED: There was no significant difference in BIA and BIV between the healing intervals for any of the grafting materials (P > 0.05). ANOVA exhibited comparable BIA and BIV between the grafting materials at 2 and 4 months after surgery (P > 0.05), although a significant difference was observed after 6 months (P < 0.05). Pairwise comparisons revealed that BIA was significantly greater in the autograft-stabilized than the synthetic-grafted sites (P = 0.035). The samples augmented with autograft also showed significantly higher BIV than those treated by the xenogenic (P = 0.017) or synthetic (P = 0.002) particles.
UNASSIGNED: All graft materials showed comparable performance in providing mineral support for implants up to 4 months after surgery. At the long-term (6-month) interval, autogenous bone demonstrated significant superiority over xenogenic and synthetic substitutes concerning the bone area and volume around the implant.