Novel application of absorbable gelatine sponge combined with polyurethane film for dermal reconstruction of wounds with bone or tendon exposure.

Trauma, burns, and diabetes result in nonhealing wounds that can cause bone or tendon exposure, a significant health threat. The use of an artificial regeneration template combined with skin grafting as an alternative method to highly invasive flap surgery has been shown to be an effective way to cover full-thickness skin defects with bone or tendon exposure for both functional and aesthetic recovery. However, artificial regeneration templates, such as Pelnac, are overwhelmingly expensive, limiting their clinical use. Here, we demonstrate for the first time that polyurethane film combined with absorbable gelatine sponge, affordable materials widely used for haemostasis, are effective for dermal reconstruction in wounds with bone or tendon exposure. The absorbable gelatine sponge combined with polyurethane film was applied to eight patients, all resulting in adequate granulation that fully covered the exposed bone or tendon. The outcome of absorbable gelatine sponge combined with polyurethane film application indicates that this approach is a potential novel and cost-effective dermal reconstruction strategy for the treatment of severe wounds with bone or tendon exposure.

Pectus excavatum ­ Correção cirúrgica utilizando tala externa de poliuretano fabricada com tecnologia de impressão 3D / Pectus excavatum ­ Surgical correction, using polyurethane external splint made with 3D printing technology

Objetivou-se relatar o emprego de uma tala externa confeccionada com material de poliuretano e cobertura interna de neopreme na reparação cirúrgica do pectus excavatum em um felino jovem. O felino apresentava deformidade anatômica congênita na região do externo e sinais clínicos respiratórios. Imagens avançadas de tomografia foram utilizadas para moldar a tala impressa com tecnologia tridimensional. Esta alternativa possibilitou melhor planejamento cirúrgico e, com isso, conforto para o paciente, além da qualidade própria do material de poliuretano que é levemente maleável, o que permitiu melhor moldagem e expansão torácica durante a respiração. A tala se provou resistente o suficiente para suportar a tração ocasionada pelos fios de sutura e possibilitou o reposicionamento adequado do osso esterno ao mesmo tempo que se mostrou confortável e acarretou mínimas lesões ao paciente.

The aim of this paper was to report the use of an external splint made of polyurethane material and internal neopreme covering in the surgical repair of a pectus excavatum in a young feline. The feline exhibited a congenital anatomical deformity in the external region and clinical respiratory signs. Advanced CT images were used to shape the 3D-printed splint. This alternative allowed better surgical planning and, therefore, comfort for the patient, this because to the quality of the polyurethane material, which is slightly malleable, and allowed for better molding and chest expansion during breathing. The splint proved to be strong enough to withstand the traction caused by the suture threads and allowed the proper repositioning of the sternum, at the same time it was comfortable and caused minimal injuries to the patient.

Pegylated dendritic polyurethane as unimolecular micelles for tumor chemotherapy: Effect of molecular architecture.

Unimolecular micelles have attracted intense interests as drug carriers for tumor chemotherapy owing to their superior stability in comparison with the self-assembled supramolecular ones. Among them, the dendritic polymers with the polar frameworks could favour the loading of chemotherapeutic drugs rather than the hyperbranched polymers via radical polymerization, by enhancing the interaction with drugs. While the tedious synthesis procedure for dendritic polymers could be simplified with the construction principle on urethane chemistry. Here, the PEGylated dendritic polyurethanes, Ph-DPUGly-PEG and Ph-DPUTEA-PEG, were designed with glycerol or triethanolamine as monomer, respectively. The effect of the molecular architecture of the Ph-DPU-PEGs unimolecular micelles on the controlled drug releasing performance was compared. It was found that the Ph-DPUTEA-PEG with tertiary amine as branching points could efficiently endow the pH-triggered drug release, due to its protonation.

A Comparison Between Polyurethane and Collagen Meniscal Scaffold for Partial Meniscal Defects: Similar Positive Clinical Results at a Mean of 10 Years of Follow-Up.

PURPOSE: To compare, at long-term follow-up, the clinical outcomes and failures of collagen and polyurethane meniscal scaffolds for the treatment of partial meniscal defects. METHODS: Patients affected by partial meniscal defect with intact anterior and posterior meniscal attachments and an intact rim at the circumference of the missing meniscus were included, treated with a collagen meniscal implant or with polyurethane scaffold, and clinically evaluated by analysis of the subjective International Knee Documentation Committee score, the visual analog scale score for the evaluation of knee function and symptoms, and the Tegner score to assess the activity level. RESULTS: After 3 patients dropped out, a total of 47 patients, comprising 31 men and 16 women, with a mean age of 43 ± 14.1 years and mean body mass index of 25 ± 1.4, were clinically evaluated up to a mean of 10 years' follow-up. The International Knee Documentation Committee score improved from 42.9 ± 15.9 to 67.4 ± 12.4 (P < .0005) in the polyurethane implant group and from 46.8 ± 16.7 to 62.1 ± 22.6 (P < .0005) in the collagen meniscal implant group. The visual analog scale score decreased significantly from baseline values of 5.4 ± 2.3 and 4.4 ± 1.7, to 3.4 ± 2.5 and 2.7 ± 2.4, respectively, at final follow-up in the polyurethane implant (P = .002) and collagen meniscal implant (P < .0005) groups. The Tegner score improved in both groups without reaching the preinjury activity level. No significant differences in the scores were found between the polyurethane and collagen scaffold groups. A total of 10 implants failed, 5 per group, for a cumulative failure rate of 21.3%, with no differences between the 2 scaffolds. CONCLUSIONS: The long-term comparison showed positive and similar results for both polyurethane- and collagen-based meniscal scaffolds, with an implant survival rate of about 80% at 10 years of follow-up and no differences in terms of pain, function, and activity level. LEVEL OF EVIDENCE: Level IV, case-control comparative study.

Biodegradable polyurethane nerve guide conduits with different moduli influence axon regeneration in transected peripheral nerve injury.

Nerve guide conduits (NGCs) can replace autogenous nerve grafting in the treatment of peripheral nerve system (PNS) injury. However, the modulus of polyurethane NGCs that affects the outcome of PNS repair has been rarely elucidated in vivo. In this study, we developed biodegradable waterborne polyurethane (BWPU) NGCs with an outer BWPU membrane and an inner three-dimensional scaffold structure. The mechanical properties of BWPU NGCs can be modified by adjusting the molar content of polyethylene glycol (PEG) in the soft segments within the BWPU. Two types of BWPU NGCs with different moduli were prepared, containing 17% and 25% PEG in BWPU (termed as BWPU 17 NGCs and BWPU 25 NGCs, respectively). In rat sciatic nerves with 10-mm transected injury, mechanically stronger BWPU 17 NGCs exhibited superior nerve repair, which was similar to that obtained by the current gold standard autograft implantation, whereas weaker BWPU 25 NGCs displayed an unsatisfactory effect. Histological results revealed that both BWPU NGCs had anti-inflammatory effects and altered the activation state of macrophages to M2 phenotypes to enhance PNS regeneration. The analysis of growth-associated protein 43 expression, which regulates axon growth, revealed that the mechanical properties of BWPU NGCs influence the outcome of PNS regeneration by affecting the formation and extension of axons. These findings suggest that the mechanical properties of NGCs could play a key role in regulating PNS repair and should be considered in future biomaterial NGC designs.

Polyurethane scaffold implants for partial meniscus lesions: delayed intervention leads to an inferior outcome.

PURPOSE: The purpose of this study was to assess the clinical outcomes of the implantation of an aliphatic polyurethane scaffold for the treatment of partial loss of meniscal tissue at a mean follow-up of 36 months. METHODS: A retrospective review on prospectively collected data was performed on patients who underwent implantation of an aliphatic polyurethane-based synthetic meniscal scaffold. Patients were evaluated for demographics data, lesion and implant characteristics (sizing, type and number of meniscal sutures), previous and combined surgeries and complications. Clinical parameters were rated using NRS, IKDC subjective, Lysholm, KOOS, and Tegner activity score, both preoperatively and at final follow-up. RESULTS: Sixty-seven patients were evaluated at a mean follow-up of 36 months (48 M and 19 F; mean age 40.8 ± 10.6 years; mean BMI 25.4 ± 4.3). The scaffold was implanted on the medial side in 54 cases, and on the lateral one in 13. Forty-seven patients had undergone previous surgical treatment at the same knee and 45 required combined surgical procedures. All evaluated scores improved significantly from the baseline. Among possible prognostic factors, a delayed scaffold implantation had lower post-operative clinical scores: IKDC subjective (P = 0.049), KOOS Sport (P = 0.044), KOOS total (p = 0.011), and Tegner (P = 0.03) scores at follow-up. CONCLUSIONS: The polyurethane meniscal scaffold implantation led to a significant clinical benefit in a large number of patients. A delayed intervention correlated with worse results. LEVEL OF EVIDENCE: IV.

Retained Negative Pressure Wound Therapy Foams as a Cause of Infection Persistence.

Significance: Negative pressure wound therapy (NPWT) has become a valuable adjunct in the treatment of acute and chronic wounds in several surgical disciplines. Retained foams are among its side effects, and they pose a rare but devastating complication at the site of this therapy, which might be associated with wound-healing complications, infection persistence, repeated surgical revisions, and prolonged antibiotic courses. Recent Advances: In the past 15 years, an increasing number of studies have identified this potential problem. Although the exact incidence remains unknown, initial studies have indicated rates of up to 10% in large collectives being treated by NPWT. Critical Issues: The lack of radiopaque markers does not allow for the visual control of retained foams using plain radiographs. Further imaging methods (e.g., CT and MRI) also do not help in adequate differential diagnosis. The lack of routine documentation of the number, type, and localization of the inserted foam(s) and unplanned surgery with a different surgical team pose risk factors for foam retainment. Future Directions: Introducing new documentation records for wounds treated with NPWT is recommended. At foam removal, all dressing materials should be examined for integrity. The development of foams with radiopaque markers by the industry, such as those routinely used in surgical gauze swabs, might also be a useful step to minimize the risk of foam retainment within wounds.

Comparing Five New Polymer Barriers for the Prevention of Intra-abdominal Adhesions in a Rat Model.

BACKGROUND: Intra-abdominal adhesions affect up to 93% of the patients after abdominal surgery, causing small-bowel obstruction, infertility, chronic abdominal pain, and iatrogenic bowel injury at reoperation. The efficacy of five new polymer antiadhesive barriers to avoid adhesion formation is evaluated in an ischemic button model in rats. MATERIALS AND METHODS: Five new, biodegradable polyurethane and copolyester-based, antiadhesive barriers (A1, A2, A3, B1, and B2) were evaluated in separate experimental groups and compared with two control groups (hyaluronate carboxymethylcellulose barrier and no antiadhesive barrier) in an ischemic button model (n = 11 per group operated). After 14 d, the quantity and quality of the adhesions were scored macroscopically. The Kruskal-Wallis with Mann-Whitney U post hoc and the Fisher's exact tests were used for data analysis. The Bonferroni correction method was applied, and a P-value <0.007 was considered significant. RESULTS: Two animals died during surgery and follow-up. A significant reduction of adhesions to ischemic buttons was found in the A2 group (median, 3.5; interquartile range, 2.25) compared with no adhesive barrier (median, 8.0; interquartile range, 2.0) (P = 0.001). The remaining groups did not differ significantly regarding adhesion quantity or quality. Adverse events were observed in the A2, A3, and B2 groups. CONCLUSIONS: The A2 antiadhesive barrier reduced the adhesion formation significantly compared with no anti-adhesive barrier, but applicability is questionable because of extensive adverse events observed due to implantation of the anti-adhesive barrier. The Nair score appears not to be sensitive enough to detect differences in adhesion formation in this model. Future research should focus on anti-adhesive barriers that are self-adhering.

Treating skin graft donor sites: a comparative study between remnant skin use and polyurethane foam.

OBJECTIVE: Excess remnant skin is retained for use in additional grafting in case of split-thickness skin graft (STSG) failure. We hypothesise that regrafting with remnant skin offers greater efficacy and advantages in wound healing and donor site appearance. METHODS: Skin graft donor sites were assessed by comparing those regrafted with remnant skin with those treated with polyurethane foam dressing. Healing time, pain, patient satisfaction, itching sensation, skin stiffness and irregularity between regrafting and foam dressing were compared. The aesthetic satisfaction of donor site was evaluated by four board-certified plastic surgeons. The differences were tested statistically. RESULTS: A total of 39 patients received a STSG due to skin or soft tissue wounds caused by burn, trauma and cancer reconstruction. The donor site healing time was shorter with remnant skin regrafting compared with foam dressing. There was no difference with respect to donor site pain between the two treatment groups. At two weeks after skin graft, patient satisfaction was higher in those treated with remnant skin than in those treated with foam dressing. Aesthetic assessment was improved after 12 weeks. CONCLUSION: Donor site dressing using remnant skin appears to improve wound healing and enhance the aesthetic outcome of donor sites.

Are the Biological and Biomechanical Properties of Meniscal Scaffolds Reflected in Clinical Practice? A Systematic Review of the Literature.

The aim of this PRISMA review was to assess whether the CMI and Actifit scaffolds, when used in clinical practice, improve clinical outcomes and demonstrate the ideal biological and biomechanical properties of scaffolds: being chondroprotective, porous, resorbable, able to mature and promote regeneration of tissue. This was done by only including studies that assessed clinical outcome and used a scale to assess both integrity of the scaffold and its effects on articular cartilage via MRI. A search was performed on PubMed, EMBASE, Scopus and clinicaltrials.gov. 2457 articles were screened, from which eight studies were selected: four used Actifit, three used CMI and one compared the two. All studies reported significant improvement in at least one clinical outcome compared to baseline. Some studies suggested that the scaffolds appeared to show porosity, mature, resorb and/or have possible chondroprotective effects, as assessed by MRI. The evidence for clinical translation is limited by differences in study methodology and small sample sizes, but is promising in terms of improving clinical outcomes in the short to mid-term. Higher level evidence, with MRI and histological evaluation of the scaffold and articular cartilage, is now needed to further determine whether these scaffolds exhibit these useful properties.

Evaluation of a Novel Degradable Synthetic Biomaterial Patch for Augmentation of Tendon Healing in a Large Animal Model.

Tendon injury is common in sports. The standard of care (SOC) for tendon repair is surgical treatment. However, restored tendons often lack complete strength and functionality, and surgical repair is often unsuccessful. This controlled laboratory study investigates the healing of an Artelon patch (AP)-augmented tendon versus tendon repair alone in a preclinical canine patellar tendon defect model. Full-thickness proximal and distal flap defects were created in the patella tendons of eight purpose-bred research mongrel dogs. Dogs were randomly allocated into either the AP-augmented repair group or the SOC group (N = 8; four knees per group). Outcomes measures included limb function and pain; range of motion (ROM) and ultrasound assessment at 2, 4, and 8 weeks; and measurements of elongation, biomechanical testing, and histology at 8 weeks. Data were compared for statistically significant differences to preoperative measures and between groups (p < 0.05). The AP group had higher limb function scores compared with the SOC group at 2, 4, and 8 weeks, with statistically significant differences observed at 2 weeks (AP: 7.1 ± 1.4, SOC: 5.5 ± 0.4, p < 0.05) and 8 weeks (AP: 9.5 ± 0.7, SOC: 7.0 ± 0.9, p < 0.05). The ROM was significantly higher for the AP group at 4 weeks (AP: 105 degrees ± 4, SOC: 89 degrees ± 5, p < 0.05). Pain scores were statistically significantly lower in the AP group at 4 (AP: 0.6 ± 0.5, SOC: 2.2 ± 0.5) and 8 weeks (p < 0.05 for both comparisons). All animals in the AP group displayed full bridging tissue at week 4, while most animals of the SOC group displayed full bridging by week 8. Minimal tendon elongation was observed in both groups. Significantly more force was required to elongate tendons in the AP group compared with the SOC group (p < 0.05). Animals with AP-augmented tendon repair show an earlier regain of function, earlier regain of range of movement, less postoperative pain, and improved tendon strength when compared with animals treated with tendon repair alone.

Polyurethane scaffolds seeded with autologous cells can regenerate long esophageal gaps: An esophageal atresia treatment model.

BACKGROUND: Pediatric patients suffering from long gap esophageal defects or injuries are in desperate need of innovative treatment options. Our study demonstrates that two different cell sources can adhere to and proliferate on a retrievable synthetic scaffold. In feasibility testing of translational applicability, these cell seeded scaffolds were implanted into piglets and demonstrated esophageal regeneration. METHODS: Either porcine esophageal epithelial cells or porcine amniotic fluid was obtained and cultured in 3 dimensions on a polyurethane scaffold (Biostage). The amniotic fluid was obtained prior to birth of the piglet and was a source of mesenchymal stem cells (AF-MSC). Scaffolds that had been seeded were implanted into their respective Yucatan mini-swine. The cell seeded scaffolds in the bioreactor were evaluated for cell viability, proliferation, genotypic expression, and metabolism. Feasibility studies with implantation evaluated tissue regeneration and functional recovery of the esophagus. RESULTS: Both cell types seeded onto scaffolds in the bioreactor demonstrated viability, adherence and metabolism over time. The seeded scaffolds demonstrated increased expression of VEGF after 6 days in culture. Once implanted, endoscopy 3 weeks after surgery revealed an extruded scaffold with newly regenerated tissue. Both cell seeded scaffolds demonstrated epithelial and muscle regeneration and the piglets were able to eat and grow over time. CONCLUSIONS: Autologous esophageal epithelial cells or maternal AF-MSC can be cultured on a 3D scaffold in a bioreactor. These cells maintain viability, proliferation, and adherence over time. Implantation into piglets demonstrated esophageal regeneration with extrusion of the scaffold. This sets the stage for translational application in a neonatal model of esophageal atresia.

Scarring At Donor Sites After Split-Thickness Skin Graft: A Prospective, Longitudinal, Randomized Trial.

OBJECTIVE: The aim of this study was to evaluate scarring at split-thickness skin graft donor sites 8 years after surgery. METHODS: At surgery, 67 patients were randomized to hydrofiber, polyurethane foam, or porcine xenograft treatment. Scars were evaluated with the Patient and Observer Scar Assessment Scale. RESULTS: Results showed significant differences in observed scar outcomes at donor sites, leaving the polyurethane foam-treated and the porcine xenograft-treated patients with the least satisfying scars. Multivariable regression analysis showed that the group treated with the xenografts had worse scores for overall opinion of the scar than did the other groups (P = .03), the most important factor being pigmentation. There was no correlation between duration of healing time and quality of the scar. CONCLUSIONS: There were significant differences among the groups, with the hydrofiber group being the most satisfied with the appearance of their scar.

Arthroscopic Coracoclavicular Ligament Reconstruction Using a Synthetic Polycaprolactone-Based Polyurethane Urea Tendon Graft: A Report of 5 Cases.

BACKGROUND: Several techniques have been introduced to treat acromioclavicular (AC) separation using the semitendinosus tendon as a graft for coracoclavicular (CC) ligament reconstruction. However, the tendon may have been used previously or the patient may not want it harvested. Hence, synthetic tendon transfers have become increasingly popular. METHODS: Five patients with chronic AC separations were treated. A synthetic polyurethane urea tendon graft (Artelon Tissue Reinforcement [ATR]) was chosen for its ability to partially transform into connective tissue. The patient follow-up period lasted 45 to 60 months. RESULTS: The mean preoperative Constant Score increased from 64.8 to 100 postoperatively. The mean preoperative Simple Shoulder Test increased from 7.2 to 12 postoperatively. The mean postoperative increase of the CC distance was 1.5 mm. The mean expansion of the clavicular drill hole from the original was 2.1 mm. According to the postoperative magnetic resonance imaging, the grafts had healed well and the cross-sections of the grafts were up to 10.5 mm between the coracoid and the clavicle. DISCUSSION: The synthetic ATR tendon strip was a practical method for reconstructing a torn CC ligament complex. The ATR graft appears promising for future CC ligament reconstructions.

Similar clinical outcomes following collagen or polyurethane meniscal scaffold implantation: a systematic review.

PURPOSE: The purpose of this systematic review is to evaluate the current literature in an effort to assess specific clinical outcomes following meniscal scaffold implantation using the two available scaffolds: Collagen Meniscal Implant (CMI) and the Actifit polyurethane meniscal scaffold. METHODS: A systematic review was performed by searching PubMed, Embase, and Cochrane Library to find studies evaluating clinical outcomes of patients undergoing meniscal scaffold implantation. Search terms used were "meniscus", "meniscal", "scaffold", and "implant". Studies were evaluated based on scaffold type, treatment failure rates, patient-reported outcome scores, concomitant procedures, and radiological findings. Radiological findings were recorded using the Genovese scale to assess morphology and signal intensity and the Yulish score to assess articular cartilage. RESULTS: Nineteen studies (1 level I, 1 level II, 17 level IV evidence) were identified that met inclusion criteria, including a total of 658 patients (347 Actifit, 311 CMI). The overall average follow-up was 45 months. Treatment failure occurred in 9.9% of patients receiving the Actifit scaffold at a mean follow-up of 40 months and 6.7% of patients receiving CMI at a mean follow-up of 44 months (n.s.). However, the rate of failure ranged from 0 to 31.8% amongst the included studies with a variable definition of failure. Additionally, overlapping patients and presence of concomitant surgeries such as anterior cruciate ligament reconstruction (ACLR) and high tibial osteotomy (HTO) may have a significant influence on these results. Outcomes for the Visual Analog Scale (VAS) for pain, Lysholm knee score, and Tegner activity score improved from preoperatively to latest follow-up in both groups, while the Knee Injury and Osteoarthritis Outcome Score and International Knee Documentation Committee scores improved from preoperatively to latest follow-up for Actifit scaffold patients. Overall, patients receiving CMI scaffolds had higher grades for Genovese morphology and signal intensity when compared to Actifit scaffold patients. CONCLUSION: Patients undergoing meniscal scaffold implantation with either CMI or Actifit scaffold can both be expected to experience improvement in clinical outcomes when used in association with concomitant procedures such as ACLR and HTO. LEVEL OF EVIDENCE: IV, systematic review.

Soft silicone foam dressing is more effective than polyurethane film dressing for preventing intraoperatively acquired pressure ulcers in spinal surgery patients: the Border Operating room Spinal Surgery (BOSS) trial in Japan.

Preventing intraoperatively acquired pressure ulcers (IAPUs) in patients undergoing spinal surgery in the prone position using a Relton-Hall frame is challenging. We investigated the efficacy of soft silicone foam dressings in preventing IAPUs. A prospective dual-center sham study was conducted among patients undergoing elective spinal surgery in a general hospital and a university hospital in Japan. The incidence of IAPUs that developed when soft silicone foam dressings and polyurethane film dressings were used was compared on two sides in the same patient. IAPUs developed on the chest in 11 of 100 patients (11%). Polyurethane film dressings were associated with a significantly higher rate of IAPUs than soft silicone foam dressings (11 versus 3, P = 0·027). A multivariate logistic regression analysis revealed that a diastolic blood pressure of <50 mmHg (P = 0·025, OR 3·74, 95% confidence interval [CI] 1·18-13·08) and the length of surgery (by 1 hour: P = 0·038, OR 1·61, 95% CI 1·03-2·64) were independently associated with the development of IAPUs. The use of soft silicone foam dressings reduced the risk of IAPUs (P = 0·019, OR 0·23, 95% CI 0·05-0·79) and was more effective than film dressings for preventing IAPUs in spinal surgery patients.

Comparison of the effect of aerosolized fibrin sealant and biodegradable synthetic polyurethane foam on hemostasis and wound healing after endoscopic sinus surgery: a prospective randomized study.

BACKGROUND: Use of absorbable packing materials after functional endoscopic sinus surgery (FESS) is associated with increased patient comfort and a lack of need for packing removal. Different materials may induce different patterns of mucosal healing and hemostasis. This study investigated the effect of fibrin sealant (FS; Tisseel) or biodegradable synthetic polyurethane foam (Nasopore® ) packing on hemostasis and wound healing after FESS. METHODS: This prospective randomized controlled trial included 35 consecutive patients who underwent bilateral FESS for chronic rhinosinusitis. The patients were randomized to receive FS through aerosol spraying on 1 side and Nasopore packing on the opposite side. They were followed at 1, 2, 4, 8, and 12 weeks after surgery. Endoscopically visible packing material, crusting, adhesion, bleeding, granulation tissue formation, frontal sinus patency, and adverse effects were assessed. Subjective symptoms related to nasal packing were evaluated by using questionnaires quantified with a visual analogue scale. RESULTS: No significant differences were found between the FS-treated side and the Nasopore-packed side with respect to postoperative bleeding, adhesion, or frontal sinus patency. However, crusting and granulation were significantly lower in FS-treated nostrils (p < 0.01). The patients' satisfaction and willingness to reuse the material were not significantly different between FS and Nasopore. There were no allergic reactions to either material. CONCLUSION: FS and Nasopore were equally successful in achieving hemostasis and patient satisfaction after FESS. However, our results suggest that differential mucosal healing patterns may be induced by alternative absorbable hemostatic materials. FS-treated sides showed more optimal healing patterns than Nasopore-packed sides.

Survival of sealants in molars affected by molar-incisor hypomineralization: 18-month follow-up

Abstract The objective of this study was to evaluate the clinical survival of sealants applied in first permanent molars (FPMs) affected by molar-incisor hypomineralization (MIH), at 18 months of follow-up. Forty-one first permanent molars were selected from 21 children, 6–8 years of age. MIH was classified by one calibrated examiner (kappa = 0.80) according to EAPD criteria. The inclusion criteria were fully erupted FPMs with MIH or sound FPMs (without MIH) for which sealant treatment was indicated. The FPMs were assigned to two groups: CG (control group) and HG (MIH group). Both groups were treated with sealant (FluroShield). Clinical follow-up was performed from baseline to 18 months to assess anatomical form, marginal adaptation, retention and presence of caries, according to criteria set by the United States Public Health Service-Modified, and was conducted by a blinded examiner (kappa = 0.80). The actuarial method was used to evaluate the survival of the sealants. The survival rates for the groups were compared using Fisher’s exact test (α = 5%). The cumulative survival rates were 81% at 1 month, 68.8% at 6 months, 68.8% at 12 months, and 62.6% at 18 months for CG, and 88% at 1 month, 84% at 6 months, 76% at 12 months, and 72% at 18 months for HG. No significant difference was found between the groups. The sealants in molars affected by MIH presented a survival rate similar to the sealants in the control, suggesting that sealants may be an adequate approach for preventing carious lesions in MIH-affected molars.

A wet dressing for male genital surgery: A phase II clinical trial

ABSTRACT Purpose: This study was to confirm the safety and efficacy of BC dressing when used in surgical male wound healing at the urogenital area. Methods: Open, non-controlled clinical study of phase II. A total of 141 patients, among those children, adolescents and adults with hypospadias (112), epispadias (04), phymosis (13) and Peyronie's disease (12) that had a BC dressing applied over the operated area after surgery. A written informed consent was obtained from all participants. Study exclusion criteria were patients with other alternative treatment indications due to the severity, extent of the injury or the underlying disease. The outcomes evaluated were efficacy, safe and complete healing. The costs were discussed. Results: In 68% patients, the BC dressing fell off spontaneously. The BC was removed without complications in 13% of patients at the outpatient clinic during the follow-up visit and 17% not reported the time of removal. In 3% of the cases, the dressing fell off early. Complete healing was observed between 8th and 10th days after surgery. The BC dressings have shown a good tolerance by all the patients and there were no reports of serious adverse events. Conclusion: The bacterial cellulose dressings have shown efficacy, safety and that can be considered as a satisfactory alternative for postoperative wound healing in urogenital area and with low cost.

A wet dressing for male genital surgery: A phase II clinical trial.

PURPOSE: This study was to confirm the safety and efficacy of BC dressing when used in surgical male wound healing at the urogenital area. METHODS: Open, non-controlled clinical study of phase II. A total of 141 patients, among those children, adolescents and adults with hypospadias (112), epispadias (04), phymosis (13) and Peyronie's disease (12) that had a BC dressing applied over the operated area after surgery. A written informed consent was obtained from all participants. Study exclusion criteria were patients with other alternative treatment indications due to the severity, extent of the injury or the underlying disease. The outcomes evaluated were efficacy, safe and complete healing. The costs were discussed. RESULTS: In 68% patients, the BC dressing fell off spontaneously. The BC was removed without complications in 13% of patients at the outpatient clinic during the follow-up visit and 17% not reported the time of removal. In 3% of the cases, the dressing fell off early. Complete healing was observed between 8th and 10th days after surgery. The BC dressings have shown a good tolerance by all the patients and there were no reports of serious adverse events. CONCLUSION: The bacterial cellulose dressings have shown efficacy, safety and that can be considered as a satisfactory alternative for postoperative wound healing in urogenital area and with low cost.