Analysis of the Effects of Early Rehabilitation Treatment Conducted by Nurses on the Prevention of Tendon Adhesion after Finger Flexor Tendon Rupture: A Randomized Clinical Trial.

Objective: This study aims to analyze the application of predictive nursing in the prevention of tendon adhesion, after the anastomosis of finger flexor tendon rupture, so as to provide a basis for clinical nursing. Methods: A total of 80 patients with anastomoses of flexor tendon ruptures, investigated in our hospital from December 2017 to December 2018, were enrolled in this study. Their data formed the basis of this research. They were divided into two groups, the routine (control) group (n = 40) and the nursing group (n = 40), by the random number table method. Basic nursing methods only were used in treating the routine group, while the nursing group received basic nursing in combination with early active function exercise. The contrast indices between the two groups were recovery quality of finger flexion and extension, incidence of tendon adhesion, and nursing satisfaction rate. Results: The probability of tendon rupture and adhesion in the (predictive) nursing group was lower than that found in the control group. The outcomes with predictive nursing were more desirable. The levels of finger flexion and extension in the nursing group were significantly better than those of the control group(P < 0.05). Conclusion: The application of predictive nursing, after the anastomosis of finger flexor tendon rupture, is good for preventing tendon adhesion. Better levels of finger flexion and extension after the operation are guaranteed, and the overall recovery outcomes are better. The satisfaction levels of patients who received predictive nursing were also high, and this method is highly valued and promoted within clinical practice.

An Analysis of the Clinical Efficacy of Early Dynamic Orthosis after Finger Extensor Digitorum Rupture.

Objective: The main objective is to compare the clinical efficacy of the early use of dynamic orthosis in patients with a finger extensor digitorum rupture. Methods: A total of 50 patients with hand and foot trauma who received surgical treatment in our hospital from March 2017 to February 2021 were selected, and two patients were excluded from the study. The patients were randomly divided into two groups. The control group (group A) was treated with plaster fixation and routine rehabilitation, and the study group (group B) underwent dynamic low-temperature thermoplastic plate fixation and routine rehabilitation. Total active motion (TAM) and total passive motion (TPM) of the injured finger before treatment, one month after treatment, two months after treatment, and after corrective treatment were compared. Results: After treatment following a finger extensor digitorum rupture, the TAM and TPM of the injured fingers increased significantly in both groups. The TAM and TPM in group B were significantly better than those in group A after one and two months of treatment (P < 0.05). After two months of treatment, the rates of improvement in TAM and TPM in group B were significantly higher than those in group A. Conclusion: The early use of dynamic orthosis can significantly improve the motor function and motion amplitude of the injured finger, increase the elasticity and extension of the finger extensor digitorum, and promote the recovery of muscle strength. It is an effective corrective method for tendon contracture after finger extensor digitorum rupture and has great value in clinical application.

Sequential correction technique to avoid postoperative global coronal decompensation in rigid adult spinal deformity: a technical note and preliminary results.

PURPOSE: This study aims to evaluate this new sequential correction technique for preventing postoperative coronal imbalance. METHODS: Adult Spinal deformity (ASD) patients were stratifies into two types: primary thoracolumbar/lumbar (TL/L) curve with compensatory lumbosacral (LS) curve (Type I) and primary LS curve with compensatory TL/L curve (Type II): for Type I patients: correction of major TL/L curve and one- or two-level segmental rod installed at the convexity of the TL/L curve, L4-S1 TLIF to correct fractional curve and a short rod installed on the contralateral side and installation of long rods; for Type II patients: horizontalize L4 and L5, short rod installation at the convexity of the LS curve, distraction of curve with regional rod and installation of long rods. ASD patients were enrolled with inclusion criteria: with pre-op TL/L Cobb angle more than 30°, with pelvic fixation and with UIV over T10. Radiographic parameters were analyzed. RESULTS: Twenty-one patients were recruited (14 patients Type I and 7 Type II patients). Both Cobb angle and coronal offset were significantly improved after surgery. In Type I patients, Cobb angle was improved from 50.48° to 26.91° and coronal offset from 2.94 to 0.95 cm; in Type II patients, Cobb angle was improved from 61.42° to 28.48° and coronal offset from 2.82 to 1.38 cm. In the 10 patients with baseline coronal imbalance, 9 were corrected to coronal balance after surgery. CONCLUSION: The sequential correction technique allows decomposing the complex correction surgery into several steps, and each step focuses only on one task. It can also reduce the difficulty of rod installation due to the separated maneuvers and multi-rod system. LEVEL OF EVIDENCE: IV These slides can be retrieved under Electronic Supplementary Material.

The potential risk of spinal cord injury from pedicle screw at the apex of adolescent idiopathic thoracic scoliosis: magnetic resonance imaging evaluation.

BACKGROUND: The pedicle screw placement in scoliosis correction at the apex underlies potential risk for neurological injury. This research is to investigate the relative position of spinal cord at the apex in idiopathic thoracic scoliosis and to explore the risk of spinal cord injury from pedicle screw at the apex. METHODS: Thirty-three adolescents with thoracic scoliosis were recruited in this study. The relative position of the spinal cord in the spinal canal was calculated by measuring the distance between the spinal cord and the medial wall of the pedicle on the convex and concave side through the axial plane of the apex in T2 weighted MR image. The distance from the spinal cord to the medial wall of pedicle between concave and convex side was compared respectively. The percentage of patients was calculated according to hypothesized different space (0 mm, less than 1 mm and less than 2 mm) between medial wall of pedicle and spinal cord at the apex. RESULTS: The average distance from the spinal cord to the medial wall of pedicle at the concave side was significantly less than that at the convex side (p = 0.000) of the apex in the major thoracic curves before operation. In the concave side of the apex, the percentage of patients was 39.4, 66.7, 84. 5 % in hypothesized space (0 mm, less than 1 mm and less than 2 mm) between medial wall of pedicle and spinal cord. However, in the convex side of apex, the percentage of cases was 0, 0, 3.0 % in the same hypothesized space respectively. CONCLUSIONS: The screw placement is at a higher risk of spinal cord injury on the concave side than that on the convex side of apex in thoracic curve in MRI images. The screw placement in the concave side of apex should be evaluated carefully with MRI before operation.

[Effects of tobramycin dexamethasone eye ointment for blepharitis: multi-center clinical trial].

OBJECTIVE: To realize the effectiveness and security of Tobramycin and Dexamethasone Eye Ointment for blepharitis treatment. Design Case control studies. Participants 148 patients be diagnosed as blepharitis including 81 cases as research group and 67 cases as control group. METHODS: Multi-center randomized controlled clinical trial. The patients met the inclusion criteria from First Hospital Peking University, Beijing Tongren Hospital, Southwest Hospital, Ophthalmology Center Zhongshan University and Third Hospital Peking University were divided into two groups in Aug. to Dec. 2011. Tobramycin dexamethasone eye ointment was applied to eye lid in research group while patients in control group used tobramycin eye ointment. All patients were informed to apply warm compress to the lids, mechanically washing to the eyelids and artificial tears. At the beginning, the 7(th) day, the 14(th) day and the 28(th) day of treatment, observation of symptom, sign and side effect were recorded. RESULTS: Before treatment the difference of the symptom scores of burning sensation, tears, photophobia and itch of two groups has no statistically significant (t = 1.87, 0.43, -0.64, 0.93, P > 0.05), but the symptom scores have a statistically significant decrease (t = 1.99 - 6.90, P < 0.05) at the 7(th) day, 14(th) day, 28(th) day. Before treatment the difference of signs scores have no statistically significant except the term of new blood vessels (t = 2.32, P = 0.02) while all the signs scores have a statistically significant decrease at the 7(th) day, 14(th) day, 28(th) day. Side effect: the number of patients with elevated intraocular pressure of research and control group is 3 and 1 respectively and the ratio is 3.7% and 1.5%. CONCLUSIONS: The tobramycin dexamethasone eye ointment can improve signs and symptoms of blepharitis patients. Some patients have to face with the risk of elevated intraocular pressure and it's necessary to monitor the intraocular pressure.

Isolated extradural tuberculous granuloma of the cervical spine: a case report.

INTRODUCTION: Isolated intraspinal extradural tuberculous granuloma (IETG) without radiological evidence of vertebral involvement is uncommon, especially rare in cervical spine. MATERIALS AND METHODS: We report a case of cervical IETG without bone involvement in a patient with neurological deficit. The patient suffered from progressive neurological dysfunction. MRI of cervical spine revealed an intraspinal extradural mass, and the spinal cord was edematous because of the compression. Thus C2-C4 laminectomy was performed and extradural mass was excised. RESULTS: The excised extradural mass was confirmed to be tuberculous granuloma through pathologic examination. Antituberculous drugs were administrated with a regular follow-up. Excellent clinical outcomes were achieved. CONCLUSIONS: The isolated IETG, although a rare entity, should be considered in the differential diagnosis of the intraspinal mass, especially in patients with spinal cord compression and a history of tuberculosis. If there is a progressing neurological deficit, a combination of surgical and anti-tuberculous treatment should be the optimal choice.

Evolution of the curve patterns during brace treatment for adolescent idiopathic scoliosis.

UNLABELLED: The curve pattern of idiopathic scoliosis is important for making decisions concerning bracing. However, whether the curve pattern changes during brace treatment have not been fully documented. The aim of this study was to investigate the changes of curve pattern during brace treatment in skeletally immature patients with adolescent idiopathic scoliosis (AIS). METHODS: From January 2002 to January 2011, AIS patients treated with a Boston or Milwaukee brace were recruited after meeting the following inclusion criteria: older than 10 years of age at initiation of bracing; having a Cobb angle of 25°-40°; with a Risser sign 0-2; being regularly followed until the weaning of brace or the necessity of surgical treatment; and without history of previous treatment. A total of 130 female and 11 male AIS patients were included. The mean age was 12.9 years at initiation of bracing, and the female patients were, on average, 2.7 months past menarche. The mean follow-up period was 2.6 years (range 1.0-5.5 years). The definitions of changes in curve patterns were divided into four categories as follows: (1) shift of the apex of the main curve; (2) change in the curve span of more than two vertebrae; (3) change in the main curve type with regard to the apex location; and (4) change of curve direction. The patients were divided into two groups. Group A was comprised of patients who had experienced one or more categories of curve pattern changes, and Group B was comprised of those who had not. RESULTS: Of these 39 patients, 14 had apex shifting, 2 underwent curve span changes, 22 experienced changes in the main curve type, and one female had both changes in the apex and curve span. At the initiation of bracing, patients in Group A demonstrated significantly lower menarchal status (P = 0.018) and lower Risser grade (P = 0.025) than those in Group B. The difference in the percentage of patients who underwent Boston bracing between the two groups was statistically significant (41.5 % for Group A vs. 24.0 % for Group B, P = 0.023). CONCLUSION: Changes in curve pattern can occur during brace treatment. Patients with less skeletal maturity and those treated with a Boston brace are more susceptible to this phenomenon.

Mini-open anterior instrumentation with diaphragm sparing for thoracolumbar idiopathic scoliosis: its technique and clinical results.

The traditional method of thoracoabdominal retroperitoneal approach requires dissection of diaphragm which bears potential complications such as postoperatively weakened abdominal breathing and dysfunction of diaphragm. Mini-open anterior instrumentation with diaphragm sparing is designed to minimize the damage to diaphragm and improve cosmesis. This study compared the traditional anterior instrumentation and mini-open anterior instrumentation under the hypothesis that both results in similar surgical outcomes in treating thoracolumbar scoliosis. In Group A, 38 patients with an average age of 16.5 years underwent mini-open anterior instrumentation with diaphragm sparing. The average standing coronal Cobb angle was 56.4° in Group A. Thirty-eight patients with average age of 16.7 years in Group B received traditional open approach. The preoperative average Cobb angle was 55.8° in Group B. The average correction rate of coronal curve was 78% in group A while 75% in group B. No statistical difference between the two groups in terms of coronal curve correction, sagittal profile restoration and estimated blood loss was observed. The operation time was significantly higher in Group A than that in Group B. All patients in the two groups had good healing of incisions without neurological and instrumental complications during minimal 2 year follow-up. In Groups A and B, two patients suffered from pleural effusion, respectively. The wedging of the vertebral discs distal to the lowest fused level occurred in three and four patients in Group A and B, respectively. One case in group B was found to be suspicious pseudoarthrosis without loss of correction. Mini-open anterior instrumentation with diaphragm sparing could minimize the surgical invasion as well as achieve similar clinical outcomes compared with classical anterior approach.

[Emphasis on prevention and control of trachoma in China].

In China, in order to complete the goal of the elimination of blinding trachoma before 2020, which is presented by the World Health Organization, several steps should be taken as following. First of all, the support at all levels by government is needed, meanwhile, it is very necessary to perform a national epidemiological study about prevalence and risk factors of trachoma and to make the program of the control of trachoma in line with Chinese national condition. Finally, to promote the participation of people with strengthening the propaganda of public health knowledge about trachoma is also important. More efforts should be taken for elimination of the blinding trachoma in the most populous country before 2020.

[Intervention with thumbtack needling on spinal low back pain in Air Force crew: a randomized controlled trial].

OBJECTIVE: To observe the clinical effect on spinal low back pain (SLBP) in Air Force crew treated with novel thumbtack needling therapy and to analyze the relevant factors of the therapeutic effect. METHODS: A total of 120 Air Force crew with SLBP were randomized into a thumbtack needling group (40 cases), an external treatment group (40 cases, 1 case dropped off ) and a combined treatment group (40 cases, 1 case dropped off ). In the thumbtack needling group, the thumbtack needling therapy was adopted. The novel thumbtack needles were inserted at the lower No.6 region of the wrist-ankle acupuncture, Yaotongdian (EX-UE 7), Yaoyangguan (GV 3), etc. Each point was pressed and kneaded for 1 min each time, 3 or 4 times a day. The treatment for 3 days was taken as one course. At the interval of 2 days, 3 courses were required totally. In the external treatment group, shangshi zhitong plaster was compressed on the center of the tender site in the lumbar region, once daily, consecutively for 6 days as one course. At an interval of 1 day, 2 courses were required totally. In the combined treatment group, the treatments in the thumbtack needling group and the external treatment group were used in combination. Before and after treatment, McGill score and the score of Oswestry dysfunction index (ODI) were compared in the patients among the three groups. The average EMG (AEMG) and the mean power frequency (MPF) were analyzed by using JE-TB0810 electromyography (EMG) acquisition system to evaluate the erector spinae tension in the patients before and after treatment. The clinical effect was observed in the patient of each group and the safety was evaluated. Logistic analysis was performed on the relevant factors of therapeutic effect in the patients. RESULTS: Compared with the values before treatment, McGill scores and ODI scores were reduced (P<0.05), and AEMG and MPF increased in the patients of each group after treatment (P<0.05). After treatment, McGill scores and ODI scores in the thumbtack needling group and the combined treatment group were lower than those in the external treatment group (P<0.05), and AEMG and MPF were higher than the external treatment group (P<0.05). The total effective rates were 87.5% (35/40) and 87.2% (34/39) in the thumbtack needling group and the combined treatment group respectively and were higher than 64.1% (25/39) in the external treatment group (P<0.05). The incidence of the adverse reaction in the combined treatment group was higher than the other two groups (P<0.05). The weekly exercise frequency was the independent factor of the therapeutic effect (OR =12.166, P<0.001). CONCLUSION: The thumbtack needling therapy is significantly effective on spinal low back pain in Air Force crew and is of the safety. Hence, this therapy is applicable to be promoted in the primary care army hospital.

Hemoperfusion with HA380 in acute type A aortic dissection patients undergoing aortic arch operation (HPAO): a randomized, controlled, double-blind clinical trial.

BACKGROUND: Cardiopulmonary bypass (CPB) is an important cause of significant systemic inflammatory response syndrome (SIRS) in the surgical treatment of acute type A aortic dissection (ATAAD). In patients with arch vessel involvement, extensive surgical repairs often necessitate prolonged use of CPB and results in extensive inflammatory responses. Cytokines and chemokines released during CPB contribute to the progression of SIRS, increase perioperative complications, and negatively impact surgical outcomes. A cytokine adsorber (HA380) is expected to reduce the level of cytokines during CPB, which may decrease both intraoperative and postoperative inflammation. The purpose of this study is to investigate if HA380 is able to reduce the levels of inflammatory cytokines and decrease perioperative complications in ATAAD patients undergoing CPB and deep hypothermic circulatory arrest (DHCA). METHODS: This study is a single-center, randomized, controlled, double-blind clinical trial. The study aims to recruit 88 patients with ATAAD and aortic arch involvement who will undergo CPB and DHCA to repair the dissected aorta. Patients will be randomized equally into the CPB/DHCA only group (control group) and the CPB/DHCA + HA380 hemoperfusion group (intervention group), with 44 patients each. Patients in the control group will undergo CPB and DHCA only, while patients in the intervention group will undergo continuous hemoperfusion with HA380, in addition to CPB and DHCA. The primary outcome is a composite of major perioperative complications. The secondary outcomes include related inflammatory markers, coagulation parameters, and minor perioperative complications. To comprehensively evaluate the effect of hemoperfusion on the perioperative outcomes, we will also determine if there are differences in perioperative all-cause mortality, length of ICU stay, and total hospitalization costs. DISCUSSION: In the current trial, hemoperfusion will be applied in patients undergoing CPB and DHCA for repair of the aorta involving the aortic arch. This trial aims to test the safety and efficacy of our hemoperfusion device (HA380) in such settings. Upon completion of the trial, we will determine if HA380 is effective in reducing perioperative proinflammatory cytokine levels. Further, we will also verify if reduction in the proinflammatory cytokine levels, if present, translates to improvement in patient outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT04007484 . Registered on 1 July 2019 (retrospectively registered).

Does the Full Power-Assisted Technique Used in Pedical Screw Placement Affect the Safety and Efficacy of Adolescent Idiopathic Scoliosis Surgery?

BACKGROUND: The new full power-assisted (FPA) technique used in pedicle screw placement during adolescent idiopathic scoliosis (AIS) surgery streamlines the surgical procedure and reduces repetitive surgeon tasks. However, the use of the FPA technique may also negatively affect the surgical safety and efficacy of patients with AIS. OBJECTIVE: The purpose of this study was to investigate the effect of the FPA technique on the accuracy of pedicle screw placement, as well as on operating time, blood loss, and clinical outcomes. METHODS: A total of 105 patients with AIS with major thoracic curves treated with posterior instrumentation and fusion were randomized into 2 groups. With the new FPA technique, 427 pedicle screws were implanted in the thoracic region in 35 patients (the FPA group), and using the conventional freehand (FH) technique, 896 screws were implanted in 70 patients (the FH group). The primary end point screw position was assessed using postoperative computed tomography. Secondary end points, such as operative time, blood loss, and clinical outcomes, were also assessed. RESULTS: The FPA technique did not significantly affect the accuracy rate of the pedicle screw placement, scoliosis correction, total operating time, or total blood loss. However, the surgical times for the screw insertion phase and for each screw placement were significantly shorter for the FPA group compared with the FH group (P < 0.001). CONCLUSIONS: Compared with the conventional manual tools, use of the FPA technique seemed to be superior and had relatively shorter pedicle screw placement times, with comparable surgical safety and efficacy for patients with AIS.

Chinese Medicine Yishen Jiangu Granules () on Aromatase Inhibitor-Associated Musculoskeletal Symptoms.

OBJECTIVE: To assess the effectiveness of Yishen Jiangu Granules (, YSJGG) on aromatase inhibitor-associated musculoskeletal symptoms (AIMSS). METHODS: A single-arm, open-label study was conducted in 34 postmenopausal women with breast cancer who experienced AIMSS. Patients were treated with YSJGG for 12 weeks (12.4 g orally twice daily). The primary outcome was a change in the mean worst pain score of Brief Pain Inventory-Short Form (BPI-SF) over 12 weeks, and the second outcomes included changes in pain severity and pain-related interference of BPI-SF and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Modified Score for the Assessment of Chronic Rheumatoid Affections of the Hands (M-SACRAH), the Functional Assessment of Cancer Therapy-Breast (FACT-B), bone mineral density (BMD) and blood indices such as calcium (Ca), phosphate (P), and alkaline phosphatase (ALP). RESULTS: Of 37 women recruited, 30 initiated the therapy and 24 were evaluable at 12 weeks. The primary outcome (BPI-SF worst pain scores) achieved a 2.17-point reduction compared with baseline (5.75±1.87 vs 3.58±2.15, P<0.01). There were reductions in pain severity (decreased 1.65, P<0.01) and pain-related interference (decreased 2.55, P<0.01). The changes in WOMAC and M-SACRAH scores were similar to BPI-SF (P<0.05). In the FACT-B, only physical well-being and functional well-being were improved compared with baseline (P<0.05). No clinical differences were found in BMD, Ca, P and ALP. CONCLUSION: YSJGG is an effective and well-tolerated agent to reduce AIMSS.

Screw Placement at the Apex Alters Surgical Outcomes of Moderate Lenke 1 Adolescent Idiopathic Scoliosis.

STUDY DESIGN: Retrospective study. OBJECTIVE OF THE STUDY: The objective was to investigate the effect of apical pedicle screw placement on surgical outcomes of Lenke 1 adolescent idiopathic scoliosis (AIS). SUMMARY OF THE BACKGROUND DATA: Pedicle screw instrumentation achieves satisfactory correction of scoliosis in thoracic AIS patients, but the effect of apical screw placement is unclear. MATERIALS AND METHODS: Lenke 1 AIS patients with all pedicle screw instrumentation between January 2009 and January 2011 were reviewed. According to the presence of apical vertebra instrumentation, 38 patients (group A) were identified without apical screw placement. 25 patients (group B) instrumented with both concave, and convex apical screws and 50 patients (group C) with either concave or convex apical pedicle screw instrumentation were also enrolled according to matched age and Cobb angles. Cobb angle correction, apical vertebral derotation, misplacement of apical screws, functional outcomes, and patient satisfaction were evaluated. RESULTS: Demographic parameters and preoperative Cobb angle, curve flexibility, and apex rotation were similar among the 3 groups (P>0.05). Postoperatively, there was no significant difference regarding the number of fused vertebrae, Cobb angle correction rate, or loss of correction. However, the degree of apical vertebral derotation was significantly lower in group A (17.8%) than in groups B (49.1%) and C (34.3%) (P<0.001). In group B, 6 screws inserted on the concavity and 5 on the convexity of the apex were identified as malpositioned; whereas in group C, 3 on the concavity and 2 on the convexity were malpositioned screws. Self-image and satisfaction were highest for patients in group B. CONCLUSIONS: For patients with moderate Lenke 1 AIS (Cobb angle, 50-70 degrees), the insertion of apical pedicle screws did not significantly improve curve correction, but it had a marked positive effect on the derotation of apical vertebrae, subsidence of the rib hump, and patient satisfaction.

Diagnostic Accuracy of Methylated SEPT9 for Blood-based Colorectal Cancer Detection: A Systematic Review and Meta-Analysis.

OBJECTIVES: More convenient and effective blood-based methods are believed to increase colorectal cancer (CRC) detection adoption. The effectiveness of methylated SPET9 for CRC detection has been reviewed in the newly published recommendation statement by US Preventive Services Task Force (USPSTF), while detailed instructions were not provided, which may be a result of insufficient evidence. Therefore, more evidence is needed to assist practitioners to thoroughly understand the utilization of this special maker. METHODS: Based on the standard method, a systematic review and meta-analysis was performed. Quadas-2 was used to assess the methodological quality of studies. Relevant studies were searched and screened from PubMed, Embase and other literature databases up to June 1, 2016. Pooled sensitivity, specificity and diagnostic odds ratio were summarized by bivariate mixed effect model and area under the curve (AUC) was estimated by hierarchical summary receiver operator characteristic curve. RESULTS: 25 studies were included for analysis. The pooled sensitivity, specificity and AUC were 0.71, 0.92 and 0.88, respectively. Among the various methods and assays, Epipro Colon 2.0 with 2/3 algorithm was the most effective in colorectal cancer detection. Positive ratio of mSEPT9 was higher in advanced CRC (45% in I, 70% in II, 76% in III, 79% in IV) and lower differentiation (31% in high, 73% in moderate, 90% in low) tissue. However, this marker has poor ability of identifying precancerous lesions according to current evidence. CONCLUSIONS: mSEPT9 is a reliable blood-based marker in CRC detection, particularly advanced CRC. Epipro Colon 2.0 with 2/3 algorithm is currently the optimal method and assay to detect CRC.

Multicenter Randomized Double-Blind, Placebo-Controlled Trial GORTEC (Groupe Oncologie Radiotherapie Tete et Cou) 2009-01 Evaluating the Effect of the Regenerating Agent on Radiodermatitis of Head and Neck Cancer Patients.

PURPOSE: Concomitant cetuximab and radiation therapy (RT) can induce severe radiodermatitis in patients with head and neck cancer (HNC). OTD70DERM, a regenerating agent (RGTA), is a structural and functional analogue of glycosaminoglycans. Preclinical studies have shown that topical RGTA can markedly reduce radiation-induced mucosal and cutaneous toxicities without tumor protection. The present study aimed to evaluate the effect of topical RGTA on radiodermatitis in patients with HNC undergoing RT and cetuximab, for whom RT-induced skin reactions are frequent and/or severe. The primary endpoint was the incidence of grade ≥2 radiodermatitis. METHODS AND MATERIALS: We performed a multicenter, randomized, double-blind, placebo-controlled trial of patients with newly diagnosed HNC undergoing conventionally fractionated RT (70 Gy in 35 fractions) and weekly cetuximab. Patients were randomized 1:1 to receive topical OTD70DERM or placebo on irradiated skin once daily. The National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0, was used to evaluate radiodermatitis (photographs of radiation zone). The Dermatology Life Quality Index score was also evaluated. All the skin reactions seen on the photographs were scored independently by 2 outside experts. RESULTS: Of the 76 randomized patients (38 in each arm), 72 were available for the final radiodermatitis evaluation (37 in the RGTA arm and 35 in the placebo arm). No significant difference was observed concerning the incidence or duration of grade ≥2 radiodermatitis between the 2 arms (81% for RGTA vs 80% for placebo; P=.9). Also, no significant difference was found between the 2 arms regarding grade ≥2 radiodermatitis evaluated by the 2 experts using the photographs of 68 patients (76% vs 74%; P=.78). Finally, no significant difference was found in the Dermatology Life Quality Index score (score >10, 15% vs 20%; P=.45). CONCLUSIONS: Despite the good preclinical rationale, RGTA did not reduce the incidence and severity of radiodermatitis in patients with HNC.