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Objective: To investigate in-depth speech results in the Scandcleft Trial 2 with comparisons between surgical protocols and centers and with benchmarks from peers without cleft palate., Design: A prospective randomized clinical trial., Setting: Two Swedish and one Finnish Cleft Palate center., Participants: One hundred twelve participants were 5-years-old born with unilateral cleft lip and palate randomized to either lip repair and soft palate closure at 4 months and hard palate closure at 12 months or lip repair at 3 to 4 months (Arm A), or a closure of both the soft and hard palate at 12 months (Arm C)., Main Outcome Measures: A composite measure dichotomized into velopharyngeal competency (VPC) or velopharyngeal incompetency (VPI), overall assessment of velopharyngeal function (VPC-Rate), percentage of consonants correct (PCC score), and consonant errors. In addition, number of speech therapy visits, average hearing thresholds, and secondary surgeries were documented to assess burden of treatment., Results: Across the trial, 53.5% demonstrated VPC and 46.5% VPI with no significant differences between arms or centers. In total, 27% reached age-appropriate PCC scores with no statistically significant difference between the arms. The Finnish center had significantly higher PCC scores, the Swedish centers had higher percentages of oral consonant errors. Number of speech therapy visits was significantly higher in the Finnish center., Conclusion: At age 5, poor speech outcomes with some differences between participating centers were seen but could not be attributed to surgical protocol. As one center had very few participants, the results from that center should be interpreted with caution.

Objectives: The aim of this study was to describe speech at 1, 1;6 and 3 years of age in children born with unilateral cleft lip and palate (UCLP) and relate the findings to operation method and amount of early intervention received., Methods: A prospective trial of children born with UCLP operated with a one-stage (OS) palatal repair at 12 months or a two-stage repair (TS) with soft palate closure at 3-4 months and hard palate closure at 12 months was undertaken (Scandcleft). At 1 and 1;6 years the place and manner of articulation and number of different consonants produced in babbling were reported in 33 children. At three years of age percentage consonants correct adjusted for age (PCC-A) and cleft speech errors were assessed in 26 of the 33 children. Early intervention was not provided as part of the trial but according to the clinical routine and was extracted from patient records., Results: At age 3, the mean PCC-A was 68% and 46% of the children produced articulation errors with no significant difference between the two groups. At one year there was a significantly higher occurrence of oral stops and anterior place consonants in the TS group. There were significant correlations between the consonant production between one and three years of age, but not with amount of early intervention received., Conclusions: The TS method was beneficial for consonant production at age 1, but not shown at 1;6 or 3 years. Behaviourally based early intervention still needs to be evaluated.

Objective: This study investigates the impact of maxillary advancement (Le Fort I osteotomy) on consonant proficiency in patients with cleft lip and palate (CLP) and explores how these patients and lay people perceive their speech 1 year post Le Fort I osteotomy., Design: Retrospective group study before and after treatment., Participants: All patients with CLP who had undergone Le Fort I osteotomy for maxillary retrognathia between 2007 and 2010 at Karolinska University Hospital, Sweden (n = 21). Six patients were excluded due to additional malformations and missing data. Two experienced speech and language pathologists assessed consonant proficiency, and speech accuracy was determined by lay listeners from pre- and postoperative standardized audio recordings. The patients' satisfaction with speech postoperatively was collected from medical records., Main Outcome Measures: Percentage of oral consonants correct and acoustic analysis of /s/, lay listeners' opinion, and patients' satisfaction with speech., Results: One year postoperation, 11 of the 15 patients had improved articulation, especially on the /s/-sound, without speech intervention. The mean percentage of oral consonants correct before treatment (82%) was significantly improved later (95%; P > .01). This assessment was supported by the patients' satisfaction with speech. However, lay listeners' opinion on accuracy was inconsistent. Length of maxillary advancement or change in occlusion did not correlate with change in articulation., Conclusion: Maxillary advancement performed to normalize occlusion and facial profile improved consonant proficiency in patients with CLP 1 year postoperation. Lay listeners' and patients' perceptions of speech need further exploration.

Objectives: (1) To evaluate dental arch relationships, with the Great Ormond Street, London and Oslo (GOSLON) Yardstick, of participants with Unilateral cleft lip and palate (UCLP) and treated with 1-stage palatal closure with 3 different surgical protocols (2) to compare the mean GOSLON ratings with other CLP centers., Design: Retrospective study of medical charts and dental models., Setting: Karolinska University Hospital, Stockholm, Sweden., Participants: Eighty-seven patients with UCLP operated with 1-stage palatal repair. Thirty-five were operated with Veau-Wardill-Kilner (VWK) technique 1975 to 1986, 31 with minimal incision technique (MIT) from 1987 to 1997, and 21 according to MIT with muscle reconstruction (MITmr) 1998 to 2004., Interventions: Dental casts at ages 5 (n = 87), 7 to 8 (n = 27), 10 (n = 81), 16 (n = 61), and 19 (n = 35) years were rated by 10 assessors with the GOSLON Yardstick. Information of other interventions was retrieved from patients' charts., Main Outcome Measures: Mean GOSLON ratings., Results: A total of 82% of the participants were rated as having excellent to satisfactory outcome. Weighted κ statistics for the 10 assessors was good for inter-rater agreement and good/very good for intra-rater agreement., Conclusions: The mean GOSLON score in the Stockholm overall material at age 10 was 2.67. The VWK technique resulted in a greater need of orthognathic surgery than the MIT ( P < .01). The MITmr did not produce better dental arch relationships than MIT at age 5 ( P < .05). The best dental arch relationships were found in the MIT group at 10 years, mean 2.58, which is not significantly different from other centers with excellent outcome except Gothenburg and Vienna.

Background: The aim of this study was to investigate speech outcomes in children with clefts in the hard and/or soft palate only (CPH/CPS), in order to determine the prevalence of cleft speech characteristics, the change between 5 and 10 years of age, and the difference in occurrence between CPH and CPS., Methods: A consecutive series of 88 children born with CPH or CPS were included in a retrospective cohort. All participants were treated with one-stage palatal repair using a minimal incision technique with muscle reconstruction (mean age 13 months). Twelve children (14%) received a velopharyngeal flap. Cleft speech variables were rated at 5 and 10 years of age independently by three experienced external speech-language pathologists. Inter- and intra-rater agreements were determined, and the prevalence of cleft speech characteristics was calculated., Results: Moderate-to-severe hypernasality and weak pressure consonants were present in 5%-10% of the children at 5 years, with marginal but statistically significant improvement at 10 years of age. Frequently or always occurring audible nasal air leakage was detected in 20% of children at age 5, and increased to ∼35% of the children at 10 years. Ten per cent had compensatory articulation at age 5, and 25% demonstrated s-distortions, whereas few had these problems at age 10., Conclusions: The results demonstrate low occurrence of compensatory articulation problems in this cohort, even by 5 years of age. The high presence of symptoms of velopharyngeal insufficiency at 10 years of age suggests a need for additional secondary velopharyngeal surgery.

Objective: Children with cleft lip and palate have a high prevalence of otitis media with effusion (OME) which is often associated with a fluctuating, conductive hearing loss in the low and mid-frequencies and a risk for permanent hearing loss in the higher frequencies. Although common, there is no consensus on the treatment of OME with ventilation tubes. The aim of this study is to document if the risk for permanent hearing loss and acquired cholesteatoma increases due to treatment with ventilation tubes (VT treatments) during childhood in a group of children with cleft lip and palate., Methods: A retrospective medical chart review of 33 children (25 boys and 8 girls) born with unilateral cleft lip and palate (UCLP) was completed. Audiological data (results of hearing sensitivity tests, the total number of hearing tests, and number of VT treatments) were extracted from medical records from when the children were 4-7 and >7-10 years of age., Results: The hearing thresholds in the speech frequencies improved with age (p < 0,05) but a minority of the children continued to present with elevated hearing thresholds in the higher frequencies at >7-10 years of age. There were no significant correlations between number of VT treatments and hearing thresholds at >7-10 years. Four of the 33 children presented with complications: two children exhibited perforations of the ear drum (6.1%) and two children developed unilateral cholesteatoma (6.1%)., Conclusion: In the current study, the hearing sensitivity of children with cleft lip and palate improved with age. However, this improvement was not seen in the higher frequencies. Twelve percent of the children experienced complications following VT treatments. Due to these complications, it is recommended that all children with cleft palate should have routine follow-ups by an ENT doctor and audiologist. As part of the routine follow-up care, hearing assessments should be performed before and after VT treatments., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Background: Facial fractures may lead to sequelae due to the trauma but also as a result of surgery. Complications to lower eyelid incisions include ectropion, scleral show, entropion, canthal malposition, and lid edema. The aim of this study was to compare the occurrence of such complications depending on whether a subciliary or transconjunctival incision was used for surgical access., Methods: All consecutive patients surgically treated for a facial fracture between June 2005 and December 2012 with a lower eyelid incision and a minimal follow-up of 6 months were included in this retrospective study. Patients were grouped according to type of lower eyelid incision (transconjunctival vs subciliary)., Results: Out of 128 patients, 37 (29%) had a subciliary and 91 (71%) had a transconjunctival incision. In the subciliary incision group, 3 patients (8.1%) had ectropion and 4 patients (11%) had scleral show whereas 2 patients (2.2%) had ectropion, 4 patients (4.4%) had scleral show, and 2 patients (2.2%) displayed canthal malposition in the transconjunctival incision group. The differences between the groups were not statistically significant. No patient had an entropion., Conclusions: Subciliary incisions had a higher incidence of ectropion and scleral show compared with transconjunctival incisions. Transconjunctival incisions did show a low risk of canthal malposition needing surgical correction; however, the actual numbers were low. Based on this and earlier studies, the authors routinely perform transconjunctival incisions, without a lateral canthotomy if possible, for surgery of facial fractures.

Background: Longstanding uncertainty surrounds the selection of surgical protocols for unilateral cleft lip and palate, and randomised trials have only rarely been performed. The Scandcleft Project consists of three trials commenced in 1997 involving ten centres in Denmark, Finland, Norway, Sweden, and the UK. Three groups of centres tested a newly-defined common technique for palatal repair (Arm A) against their local protocols (Arms B, C, D). Arm A was familiar to most of the surgeons in Trial 1, but not to the surgeons in the other Trials., Aim: To evaluate surgical events and complications of the 448 (293 boys, 155 girls) patients with complete unilateral cleft lip and palate (UCLP) enrolled in the three trials., Method: The three trials were carried out in parallel in adherence with a fully developed, ethically approved protocol. Operative time, bleeding, complications, and major dehiscence during and after both primary surgeries were recorded by the surgeon. Rates of fistula and surgery for velopharyngeal incompetence (VPI) were assessed until the youngest patient of the study had reached the age of 9 years. Pearson Chi-square statistical analysis was used to compare the outcomes., Results: No significant differences in bleeding, infection, anaesthetic complications or length of hospital stay between the different arms were found for Trial 1. However, in Trials 2 and 3 there were more airway problems in Arm A than with the traditional local protocols (Arms C or D). In Trial 3 fistula and VPI surgery rates were also higher in Arm A., Conclusions: The results do not provide statistical evidence that any technique is better than others, but indicate that surgery was more problematic for surgeons who were still gaining experience with an unfamiliar surgical protocol., Trial Registration: ISRCTN29932826.

Background and Aims: Longstanding uncertainty surrounds the selection of surgical protocols for the closure of unilateral cleft lip and palate, and randomised trials have only rarely been performed. This paper is an introduction to three randomised trials of primary surgery for children born with complete unilateral cleft lip and palate (UCLP). It presents the protocol developed for the trials in CONSORT format, and describes the management structure that was developed to achieve the long-term engagement and commitment required to complete the project., Method: Ten established national or regional cleft centres participated. Lip and soft palate closure at 3-4 months, and hard palate closure at 12 months served as a common method in each trial. Trial 1 compared this with hard palate closure at 36 months. Trial 2 compared it with lip closure at 3-4 months and hard and soft palate closure at 12 months. Trial 3 compared it with lip and hard palate closure at 3-4 months and soft palate closure at 12 months. The primary outcomes were speech and dentofacial development, with a series of perioperative and longer-term secondary outcomes., Results: Recruitment of 448 infants took place over a 9-year period, with 99.8% subsequent retention at 5 years., Conclusion: The series of reports that follow this introductory paper include comparisons at age 5 of surgical outcomes, speech outcomes, measures of dentofacial development and appearance, and parental satisfaction. The outcomes recorded and the numbers analysed for each outcome and time point are described in the series., Trial Registration: ISRCTN29932826.

Background: Orbitozygomatic fractures often lead to infraorbital nerve (ION) injury, and affected sensibility is a common long-term complaint within this patient group. We present a long-term follow-up study where the validated von Frey filament system was used for testing ION sensibility. Furthermore, we examined the incidence of persistent nerve injury and whether more complex fractures led to more pronounced ION sensibility disturbances., Methods: Patients treated for facial fractures involving the orbitozygomatic complex were included and the follow-up time was 3 years or more. Depending on the location and severity of the fractures, the patients were divided into 4 groups. The patients answered a questionnaire before ION sensibility testing with von Frey filaments., Results: Eighty-one patients were examined: 65 males (80%) and 16 females (20%). Examinations were conducted between 3.0 and 7.6 years (mean 4.9 years) after injury. Sixteen patients (20%) had affected and 6 patients (7.4%) had severely affected ION sensibility according to von Frey testing. No statistically significant differences were found in terms of questionnaire score between the groups. There was also no statistically significant correlation between questionnaire results and log von Frey values. Although the effect of groups could not be statistically verified using the log von Frey values, a larger proportion of patients with complex fractures had higher log von Frey values than the other groups., Conclusions: Patients with complex fractures report more permanent sensory disturbance of the ION after surgery than those with isolated orbitozygomatic fractures, although this could not be verified statistically with von Frey filament testing at several locations. Hence, a validated method for testing facial sensibility such as von Frey filaments, although sensitive, is inadequate to determine all aspects of sensory malfunction after orbitozygomatic fractures. This suggests that the patient's experience of long-term sensation after trauma may not be correlated with objective measures., (Copyright © 2016 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.)

Background: Fractures in the facial skeleton are common and may lead to orbital sequelae caused by the injury and/or the surgery. In this long-term follow-up, we examined the nature of sequelae after facial fractures involving the orbit and whether a higher complexity of the fractures produced more sequelae compared to simpler fracture patterns, and if so, to what extent., Methods: Patients surgically treated for facial fractures involving the orbit at the Karolinska University Hospital with a follow-up duration of ≥3 years were included in this retrospective study and were examined by a neuro-ophthalmologist. Based on the location and severity of the fractures, the patients were divided into four groups according to fracture complexity: 1) isolated zygomatic fracture, 2) isolated orbital floor blowout fracture, 3) zygomatic fracture combined with blowout fracture and 4) bilateral or multiple fracture patterns., Results: Out of 154 patients, 81 patients (53%) attended follow-up examinations, 65 male (80%) and 16 female (20%). The duration of follow-up was 3.0-7.6 years (mean of 4.9 years). The incidence of diplopia was 3.7%, visual loss 2.5%, dystopia 4.9% and visible enophthalmos (>2 mm) 8.6%. Severe diplopia (2.5%) was due to nerve injuries. Visual loss was encountered only in group 4 with complex fractures. Fracture complexity had an effect on the presence of any sequelae, with group 4 presenting a higher percentage of patients with sequelae than the other three groups. However, no statistically significant effect of group could be found on the individual, quantitative output values of dystopia and enophthalmos., Conclusions: In this study, severe persistent diplopia in patients was due to nerve injuries, which emphasizes the need for preoperative ophthalmologic examinations, in all patients with fractures involving the orbit. A higher fracture complexity was found to lead to a higher percentage of patients presenting sequelae., (Copyright © 2014 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.)

Objective : Patients with cleft lip and palate (CLP) and maxillary retrognathia are usually treated with maxillary advancement (Le Fort I osteotomy). The aim of this study was to investigate the impact of maxillary advancement on the velopharyngeal function (VPF) and symptoms of velopharyngeal incompetence in patients with CLP. Design : Retrospective group study before and after treatment. Participants : All patients who had undergone Le Fort I osteotomy due to maxillary retrognathia from 2007 to 2010 at Karolinska University Hospital, Sweden (n = 13). Pre- and postoperatively standardized examinations were used. Blinded audio recordings were independently assessed by three experienced speech pathologists. Acoustical data (nasometry) and information on VPF (videoradiography and nasoendoscopy) were collected from the medical records. Two patients with additional malformations were considered outliers, and group data were based on a sample size of n = 11. Main Outcome Measures : Perceptual and acoustic symptoms of velopharyngeal incompetence and overall assessment of VPF. Results : No assessment method showed a significant deterioration of the VPF postoperatively. Individual data revealed that 6 of the 13 patients had no or only one symptom pre- and/or postoperatively. The two patients with additional malformations had most symptoms pre- and postoperatively and did not change. Three patients had an increased number of symptoms postoperatively by at least two symptoms. No associations between the outcome and possible prognostic factors were found. Conclusions : Maxillary advancement did not have a significant impact on the VPF at the group level, but three individuals had a somewhat deteriorated VPF postoperatively.

The repair of complex craniofacial bone defects is challenging and a successful result is dependent on the size of the defect, quality of the soft tissue covering the defect, and choice of reconstruction method. The objective of this study was to develop a bioactive cranial implant that could provide a permanent reconstructive solution to the patient by stimulating bone healing of the defect. In this paper the authors report on the feasibility and clinical results of using such a newly developed device for the repair of a large traumatic and therapy-resistant cranial bone defect. The patient had undergone numerous attempts at repair, in which established methods had been tried without success. A mosaic-designed device was manufactured and implanted, comprising interconnected ceramic tiles with a defined calcium phosphate composition. The clinical outcome 30 months after surgery revealed a restored cranial vault without postoperative complications. Computed tomography demonstrated signs of bone ingrowth. Examination with combined (18)F-fluoride PET and CT provided further evidence of bone healing of the cranial defect.

Background: Bone morphogenetic protein-2 (BMP-2) together with a suitable carrier is an attractive option that may be used for craniofacial bone reconstruction. In this prospective randomized study, a hyaluronan-based hydrogel with BMP-2 was used to achieve bone healing in standardized critical-size cranial defects in humans after neurosurgery., Methods: Twelve patients were randomized into the treatment group (N = 6) or control group (N = 6). In the treatment group, holes made during craniotomy were treated with hydrogel with BMP-2, 250 µg/mL, or hydrogel without BMP-2. In the remaining hole/s in the same patient, Spongostan (Ethicon) alone or Tisseel (Baxter) mixed with autologous bone matrix were used as negative and positive controls, respectively. In the control group, the holes were treated with Spongostan or Tisseel mixed with bone autograft. Bone healing was assessed with CT scans after 3 and 6 months. Bone areas in treated defects were measured and statistical analysis was performed., Results: Independent of location, bone healing in defects treated with Tisseel with autograft, hydrogel alone, or hydrogel with BMP-2 was significantly increased compared to negative control (P < 0.001, P = 0.002, and P = 0.005, respectively). In general, all defects healed significantly better in the frontal bone as compared to parietal-temporal location, except for defects treated with Tisseel and autograft, which healed well independently of location. No local or systemic side effects, including excessive bone overgrowth or inflammatory reaction, were seen in treated patients., Conclusions: Tissue engineering of bone with hyaluronan-based hydrogel shows good healing of cranial defects, comparable with bone autografts. The hydrogel itself may represent a novel alternative to autologous bone transplants in craniofacial bone repair. The study also reveals a general superior healing capacity in the frontal bone as compared to parietal/temporal bones.

This review aims to compare bone grafts and different biomaterials for reconstruction of craniofacial bones in congenital defects, after trauma, and after tumour surgery. A Pubmed search was performed and publications over the last 11 years describing reconstructions of craniofacial bones in non-load-bearing areas were reviewed. Only human studies using bone grafts and biomaterials were included. Studies on skull base reconstruction, distraction osteogenesis, free and pedicled bone flaps and bone-anchored epithesis were excluded. Out of 83 studies, three were prospective, 65 retrospective and 15 studies were case reports. There were seven comparative studies found and some efforts on statistical analysis were made. Except for a few studies, the statistical significant differences in outcomes were found to be related to size and location of bone defects rather than reconstruction method and biomaterial used. An increasing number of alloplastic materials have been available as alternatives to the gold standard autologous bone transplantation for craniofacial bone repair. Comparative studies with statistical analyses on differences in success rates between different biomaterials or bone grafts for specific indications are needed., (Copyright 2009 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.)

Objective: To investigate speech outcome between children with isolated cleft palate undergoing palatoplasty with and without muscle reconstruction and to compare speech outcomes between cleft and non cleft children. The number of subsequent velopharyngeal flaps was compared with respect to surgical techniques and cleft extent., Design: Cross-sectional retrospective study., Participants: One hundred four children aged 4 years, 0 months to 6 years, 0 months, 33 with isolated cleft of the soft palate, 53 with isolated cleft of the hard and soft palate, and 18 non cleft children., Interventions: Two primary palate repair techniques: minimal incision technique (MIT) and minimal incision technique including muscle reconstruction (MIT(mr))., Main Outcome Measures: Perceptual judgment of seven speech parameters assessed on a five-point scale., Results: No significant differences in speech outcomes were found between MIT and MIT(mr) surgery groups. The number of velopharyngeal flaps was significantly lower after MIT(mr) surgery compared to MIT surgery. The number of flaps was also significantly lower in children with cleft of the soft palate compared to children with cleft of the hard and soft palate. Children with cleft of the soft palate had significantly less glottal articulation and weak pressure consonants compared to children with cleft of the hard and soft palate., Conclusions: The MIT(mr) surgery technique was not significantly superior to the MIT technique regarding speech outcomes related to velopharyngeal competence, but had fewer velopharyngeal flaps, which is contradictory. Until a larger sample can be studied, we will continue to use MIT(mr) for primary palate repair.

During recent years, a new field has appeared, in which the principles of life sciences and engineering are applied to the development of methods of regenerating human tissue and organs. Since the emergence of this interdisciplinary field, plastic surgeons have been deeply involved in its development, both in the early stages and in introducing the methods into clinical practice. The article consists in discussion of the possibilities these methods offer and the impact they may have on the field of plastic and reconstructive surgery.

In order to determine the aetiology of acute epiglottitis in adults, blood cultures, paired sera and a urine sample were obtained from 54 patients with fever and epiglottitis visualized by indirect laryngoscopy or by direct fibreoptic nasolaryngoscopy. Antibodies were determined against the capsular polysaccharide of Haemophilus influenzae type b (Hib), 3 pneumococcal antigens (a mixture of 23 capsular polysaccharides, C-polysaccharide and pneumolysin) and antistreptolysin O. Acute sera were examined by the polymerase chain reaction (PCR) for DNA of Hib and pneumococci. The urine samples were examined for Hib capsular antigen. Blood cultures were positive in 15 patients. In another 16, serology and/or PCR verified the aetiology. Hib was the cause in 14, pneumococci in 12 and group A streptococci in 5 patients. The aetiology remained unknown in 23/54 patients (43%). In conclusion, the addition of serology and PCR to blood cultures doubled the possibilities of verifying the aetiology of acute epiglottitis in adults.

Background: Radiotherapy, which is often used for cancer in the head and neck, leads to damage of tissue cells and vasculature. Surgery in such tissues has an increased complication rate, because wound healing requires angiogenesis and fibroplasia as well as white blood cell activity, all of which are jeopardized. Hyperbaric oxygen therapy (HBO) raises oxygen levels in hypoxic tissue, stimulates angiogenesis and fibroplasia, and has antibacterial effects., Methods: In this consecutive retrospective study, 15 patients with soft-tissue wounds without signs of healing after surgery in full-dose (64 Gy) irradiated head and neck regions were treated with HBO and adjuvant therapy. The patients in this study were also compared with patients examined in an earlier study, with corresponding wounds treated without HBO., Results: The healing processes seemed to be initiated and accelerated by HBO. In the HBO group, 12 of 15 patients healed completely, 2 patients healed partially, and only 1 patient did not heal at all. There were no life-threatening complications. In the reference group, only 7 of 15 patients with corresponding wounds without signs of healing eventually healed without surgical intervention, and 2 patients had severe postoperative hemorrhage, which in one case was fatal., Conclusion: Evaluation of obtained results supports the hypothesis that HBO therapy has a clinically significant effect on initiation and acceleration of healing processes in irradiated soft tissues.