Subcutaneous emphysema after intralesional cryotherapy: An unusual complication.

BACKGROUND: Intralesional cryotherapy (ILC) is a safe and well tolerated by the patient. Subcutaneous emphysema (SE) cases after spray and contact cryotherapy have been described; however, this complication has not been previously reported after ILC. AIM: Our aim is to discuss the possible causes of SE development after ILC. METHOD: We present a young patient that developed SE after ILC applying by insertion of an open-ended needle to the tip of the cryotherapy gun. RESULTS: The development of SE following ILC may have been caused by inward clefting from the ear hole, the usage of an open-ended needle and a lack of safety system. CONCLUSION: It will be safer to apply special methods involving the usage of sealed distal type to prevent SE development.

The effect of botulinum toxin injection dose on the appearance of surgical scar.

Early postoperative injection of botulinum toxin type A (BTxA) can reduce surgical scar hypertrophy. BTxA injection at different time points is associated with different levels of efficacy, but the efficacy of different doses of BTxA for scar management has not investigated. The purpose of this study was to investigate the effect of different doses of BTxA administered early after surgery on scar improvement through a split-scar experiment. The study included 22 patients who underwent surgery between September 2019 and October 2020. High- and low-dose BTxA was randomly administered into each half of the surgical wound closure immediately after surgery. One half of the incision was injected with a low dose (4 U) of BTxA, and the other half was injected with a high dose (8 U). The scars were then evaluated at postoperative 6 months using the modified Stony Brook Scar Evaluation Scale (mSBSES), and patient satisfaction was evaluated using the Visual Analogue Scale (VAS). The occurrence of complications or adverse events was also recorded. Twenty patients completed the study and were analyzed. Compared with the low-dose sides, the high-dose sides had significantly better mSBSES scores and significantly higher VAS scores (p < 0.01, respectively). No serious adverse reactions or post-injection complications were observed. Immediately after the operation, high-dose BTxA (that is within the therapeutic range) injection improved the appearance of postoperative scar more than low-dose injection.

The efficacy and safety of beta-blockers versus cyanoacrylate injection for gastric variceal bleeding: A protocol for systematic review and meta-analysis.

BACKGROUND: The benefit of beta-blockers for secondary prophylaxis of gastric variceal bleeding has limited evidence. Therefore, a systematic review and meta-analysis was conducted to systematically analyze and compare the effect of beta-blockers versus cyanoacrylate injection for patients with gastric variceal bleeding. METHODS: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting guidelines will be followed to conduct the present meta-analysis. From the inception to June 2021, the Web of Science, EMBASE, PubMed, and Cochrane Library electronic databases will be searched using the key phrases "beta-blockers," "cyanoacrylate," and "gastric variceal bleeding" for all relevant English-language trials. Study included in our meta-analysis has to meet the following criteria: observational or randomized controlled trial focusing on assessing the effectiveness of beta-blockers and cyanoacrylate injection for gastric variceal bleeding; the following outcome measures are reported: bleeding from gastric variceal, overall mortality, bleed related mortality, and complications. RESULTS: This study expects to provide credible and scientific evidence for the efficacy and safety of beta-blockers versus cyanoacrylate injection for patients with gastric variceal bleeding. REGISTRATION NUMBER: 10.17605/OSF.IO/CPV9T.

Polidocanol Sclerotherapy for the Treatment of Pyogenic Granuloma in Children.

BACKGROUND: Pyogenic granuloma (PG) is a benign vascular lesion that is commonly observed in the skin and mucosa. Sclerotherapy is the first-line conservative treatment option for PG. OBJECTIVE: This retrospective study aimed to evaluate the efficacy of sclerotherapy with 1.0% polidocanol for the treatment of PG. MATERIALS AND METHODS: All patients who were clinically diagnosed with PG consecutively at the Pediatric Outpatient Service of Qilu Children's Hospital of Shandong University from March 2018 to October 2019 received sclerotherapy with 1.0% polidocanol. RESULT: The procedure resulted in the complete excision of PG, with inconspicuous scars. The procedure was well-tolerated, and recurrence was not observed. Allergic reactions, cutaneous necrosis, and pigmentary changes were not observed. CONCLUSION: Sclerotherapy with 1.0% polidocanol is considered an effective treatment for PGs in children. Early treatment was associated with a more favorable outcome.

Botulinum toxin type A versus 5-Fluorouracil in treatment of keloid.

Most therapeutic approaches for keloids remain clinically unsatisfactory. In the last years, intralesional botulinum toxin-A (IL BTX-A) was proposed for treatment of keloids. Our aim of the study was to compare the clinical efficacy of IL BTX-A and IL 5-Fluorouracil (IL 5-FU) in treatment of keloids. A total of 50 patients with keloids were included in the study, 22 patients (with 26 keloids) were treated with IL BTX-A monthly for up to 6 months and other 22 patients (with 27 keloids) were treated with IL 5-FU weekly for up to 6 weeks, while the remaining 6 patients, each having multiple keloids, were treated with both IL BTX-A for some lesions (8 keloids) and IL 5-FU for their remaining lesions (8 keloids). The clinical improvement was assessed according to flattening of the lesions. Side effects were recorded. A significantly better therapeutic response of keloids was detected after IL BTX-A than IL 5-FU (P = 0.041). IL BTX-A achieved excellent and good flattening of the lesions (58.8% and 20.6%) compared to (31.4% and 17.1%) after IL 5-FU, respectively. In BTX-A treated group, there was no statistically significant difference between the clinical response in small lesions compared to medium and large ones (P = 0.476). While in 5-FU treated group, small and medium lesions showed significantly better response than larger ones (P = 0.009). IL BTX-A caused fewer side effects than IL 5-FU, less pain, itching, no hyperpigmentation and less recurrence. Both IL BTX-A and IL 5-FU showed positive results in treatment of keloids. However, IL BTX-A showed higher clinical efficacy even in large size keloids with less side effects.

Pain Experience and Tolerance of Awake In-Office Upper Airway Procedures: Influencing Factors.

OBJECTIVES/HYPOTHESIS: Awake, unsedated in-office upper airway procedures are performed frequently and have high completion rates, yet less is known about the patients' pain experience and potentially influencing factors. It is also unclear if patients' pain experiences become worse with repeated procedures. We identified procedure- and patient-related factors that might influence procedural completion and pain scores. STUDY DESIGN: Retrospective chart review. METHODS: Pre-, intra-, and post-procedure pain scores were collected prospectively for awake unsedated upper airway procedures performed at a single institution over a 5-year period. Patient factors reviewed were demographics, body mass index, psychiatric and/or pain diagnosis, and related medications. Procedure factors reviewed were procedure type, route, side, and performance of the same procedure multiple times. Patients reported their pain level before, during, and after the procedure using a standard 0 to 10 scale. Maximum pain score change (PΔmax), or the difference between highest and lowest reported pain levels, was calculated. Descriptive and multivariate analyses were performed. RESULTS: Procedure completion was 98.7% for 609 first time patients and 99.0% in 60 patients undergoing 292 repeat procedures. PΔmax did not covary with age, gender, or BMI. PΔmax covaried with pain and psychiatric conditions and associated medications. PΔmax was highest for injection medialization and lowest for tracheoscopy. PΔmax decreased over time for those undergoing multiple identical procedures. CONCLUSIONS: Procedures were performed with a very high completion rate and low pain scores. Age, sex, and BMI did not affect pain experience. A combination of pain and psychiatric conditions did. Injection medialization had the highest PΔmax and tracheoscopy the lowest. LEVEL OF EVIDENCE: 4 Laryngoscope, 131:E1580-E1588, 2021.

[Analysis on clinical efficacy, safety and economy of Shaobei injection and elastic band ligation in the treatment of grade II or III hemorrhoids].

Objective: Currently, various treatments such as hemorrhoidectomy, ligation and sclerotherapy injection can be applied in grade II or III hemorrhoids. This study aims to compare the clinical efficacy, safety and economy between Shaobei injection and elastic band ligation in treating patients with grade II or grade III hemorrhoids. Methods: A retrospective cohort study was used. Clinical data of 60 patients with grade II or grade III hemorrhoids at Department of Anorectal Surgery of the Sixth Affiliated Hospital, Sun Yat-sen University between January 2019 and October 2019 were collected. Patients were divided into two groups according to surgical methods. Patients in the Shaobei group received Shaobei injection (n=28), and those in the ligation group received elastic band ligation (n=32). Inclusion criteria: (1) diagnosis of grade II or III hemorrhoid; (2) application of Shaobei injection or elastic band ligation; (3) age between 18-75 years old. Exclusion criteria: (1) comorbidity with anal fissure, anal fistula, anal sinusitis or other perianal diseases; (2) patients with mental disorder or poor compliance; (3) incomplete clinical or follow-up data. Recurrent rate, postoperative pain, anal edema, anal distension, total cost of hospitalization, length of hospitalization, and postoperative life quality EQ-5D-3L score were compared between the two groups at postoperative 6-month. Results: No significant difference was observed in the baseline data (including Nystrom hemorrhoid symptom score) between the two groups (all P>0.05), except gender ratio [male proportion: Shaobei 75% (21/28) vs. ligation 37.5%(12/32), χ(2)=8.485, P=0.004]. No significant difference in recurrent rate was found between the two groups [14.3% (4/28) vs. 9.4% (3/32), χ(2)=0.035, P=0.851]. Compared to the ligation group, Shaobei group showed less pain at postoperative day 1 [VAS median (range): 2 (1-6) vs. 3 (1-7), Z=2.814, P=0.005] and postoperative day 7 [VAS median (range): 0 (0-2) vs. 1 (0-4), Z=3.149, P=0.002]; lower anal edema ratio at postoperative day 1 [10.7% (3/28) vs. 34.4% (11/32), Z=4.673, P=0.037]; lower anal distension ratio at postoperative day 1 [7.1% (2/28) vs. 28.1% (9/32), Z=4.391, P=0.048]; less hospitalization cost [(6343.5±1444.1) yuan vs. (10 587.1± 1719.0) yuan, t=12.515, P<0.001] and shorter postoperative hospital stay [median (range): 1 (1-5) days vs. 3 (1-6) days, Z=5.879, P<0.001]. The EQ-5D-3L scores of two groups were significantly improved six months after treatment [Shaobei group: (0.90±0.16) vs. (0.73±0.14); ligation group: (0.91±0.13) vs. (0.74±0.10); both P<0.001], while there was no statistically significant difference between the two groups (t=0.130, P=0.897). No complications such as massive hemorrhage, infection, iatrogenic anal fistula, rectal stricture and local induration occurred after the injection. Conclusions: Shaobei injection is effective and safe in treating grade II or III hemorrhoids. Compared with elastic band ligation, it can reduce morbidity of complications and hospitalization expenses.

Long-Term Patient Experience with Tetracycline Injections for Festoons.

BACKGROUND: The purpose of this study was to evaluate the long-term patient experience with tetracycline injections for treatment of festoons. METHODS: Charts of all patients undergoing tetracycline injection for treatment of lower eyelid festoons at the Cole Eye Institute, Cleveland Clinic, between 2008 and 2018 were identified using billing records. Patients were invited to participate in a questionnaire based on the FACE-Q checklist, a previously validated questionnaire for studying cosmetic procedure outcomes. Data from the questionnaire were summarized with size, mean, and frequency. RESULTS: One hundred two patients who received tetracycline injection during the study period were identified and 61 responses were obtained. The average follow-up time after injection was 3.6 years. Of 61 respondents, 36 (59 percent) noted improvement in their festoons after treatment, and 27 of 33 (82 percent) noted that improvement occurred within 2 months of treatment. Overall, 40 of 60 respondents (67 percent) would consider repeating tetracycline treatment. The most common adverse effects included discomfort (18 percent), swelling (15 percent), and bruising (13 percent). There was no statistically significant difference in questionnaire responses between men and women, except that men were more likely to consider repeated injection (92 percent versus 58 percent; p = 0.005). CONCLUSION: Tetracycline injection appears to improve festoons in a majority of patients, with an acceptable side-effect profile, although more data are needed to determine the optimal dose and frequency and to identify possible rare and/or significant side effects.

Safety and Efficacy of Collagenase Clostridium histolyticum in the Treatment of Acute Phase Peyronie's Disease: A Multi-institutional Analysis.

OBJECTIVE: To study, in a multi-institutional setting, the efficacy/safety outcomes in acute phase Peyronie's disease (PD) of multiple high-volume centers employing CCH to treat PD, which is defined as the abnormal formation of fibrous plaque(s) in the tunica albuginea of the penis. It is a chronic condition that afflicts 3%-13% of the US male population. There is no current multi-institutional research on the efficacy and safety of collagenase Clostridium histolyticum (CCH) in the treatment of acute phase PD. METHODS: Retrospective data were collected for consecutive patients with PD who underwent treatment with CCH between April 2014 and March 2018 at 5 institutions. 918 patients were included. Patients with duration of PD no longer than 6 months at presentation qualified as being in the acute phase of PD. Main outcomes of interest include the change in curvature after receiving CCH therapy, and frequency of serious treatment-related adverse events. Successful improvement in curvature is defined as an at least 20% decrease in penile curvature from baseline after CCH therapy. RESULTS: A total of 918 patients were included in the analysis, of which 134 (14.6%) qualified as acute phase PD (group 1) and the remaining 784 (85.4%) qualified as stable phase (group 2). Mean duration of PD was 4.44 ± 1.68 months for group 1, and 40.8 ± 61.2 months for group 2. There was no significant difference in final change in curvature between acute and stable phase of PD (13.5° vs 15.6°, P = .09). There was no statistically significant difference in frequency of treatment-related adverse events between the acute phase (16 patients, 11.9%) and the stable phase (77 patients, 9.8%; P = .44). In our multivariate analysis, only number of CCH cycles received was predictive of improvement of curvature. CONCLUSION: This large multi-institutional analysis confirms that CCH therapy is as safe and efficacious in acute phase PD as it is in stable phase PD.

Talar Avascular Necrosis After Calcium Phosphate Injection Treatment of Talar Bone Marrow Lesions: A Report of 2 Cases.

CASE: We report on 2 patients who developed avascular necrosis (AVN) of the talus and poor patient outcomes after undergoing calcium phosphate injection into talar dome bone marrow lesions. CONCLUSION: Subchondroplasty, defined as calcium phosphate injection for the treatment of articular bone marrow edema, is a recently described procedure for use in the ankle joint. In our opinion, the limited available research is of poor quality and describes equivocal improvement in patient symptoms after this procedure. Given the debilitating outcomes and extensive AVN we observed in 2 patients, we strongly advise caution in the use of this procedure in the talus.

The role of steroid injection for vocal folds lesions in professional voice users.

BACKGROUND: Benign vocal fold lesions identified in professional voice users, frequently require further treatment after failure of conservative measures. The role of vocal fold steroid injection as a treatment option for select benign lesions is the focus of this study. Steroid injection may avoid phonosurgery in some individuals thereby reducing the potential for adverse side effects associated with surgery. OBJECTIVE: The purpose of the study is to review the effect of steroid injection on vocal function in professional voice users associated with a benign lesion(s) using the Voice Handicap Index-10. METHOD: This study is a retrospective review of patients (professional voice users) that underwent 1 or more steroid injection(s) between July 2014-December 2018. The Voice Handicap Index-10 was compared from pre to post treatment. Patients were identified using billing code data for laryngeal injection. Patient demographics (age, gender, profession), previous phonosurgery, date of steroid injection and follow up dates as well as VHI-10 scores were collected from the electronic medical record. RESULTS: Twenty four patients were identified. The mean Voice HandicapIndex-10 score decreased from 23.5 pre injection to 17.8 post injection which represented a reduction of 24.3%. Vocal fold steroid injection procedure in our series was associated with one complication. CONCLUSION: Vocal fold steroid injection for benign lesions is a safe, well-tolerated procedure with an improvement in vocal function without surgical intervention. Steroid injection should be considered as a treatment option to avoid surgery in patients with select vocal fold lesions.

Assessment of Image-Guided Intratumoral Delivery of Immunotherapeutics in Patients With Cancer.

Importance: Direct intratumoral delivery of immunotherapies is a compelling approach to overcoming barriers to systemic immunotherapy efficacy. While the use of intratumoral delivery of immunotherapy drugs is increasing rapidly in both the investigational and standard of care domains, the feasibility and safety of these interventions, particularly for deeper lesions that require image-guidance, remain unknown. Objective: To address current knowledge gaps in image-guided techniques for intratumoral immunotherapy delivery and the safety of these interventions. Design, Setting, and Participants: This case series study was performed at a single tertiary cancer center over a 2-year period from January 2016 to January 2018. Patients were followed until January 2019. All patients who underwent image-guided intratumoral delivery of immunotherapy agents in the standard of care, off-label, or investigational setting during the study period were included. Data were analyzed from February 1 to June 1, 2019. Exposures: Image-guided biopsies and intratumoral injections of immunotherapies across several clinical trials as well as standard of care talimogene laherparepvec therapy. Main Outcomes and Measures: Technical success, defined as the delivery of the prescribed injectate volume in its entirety, for image-guided biopsy and injections and procedure-related adverse events. Results: A total of 85 patients (median [interquartile range] age, 61 [47-71] years; 42 [52%] men) underwent 498 encounters during the study period. These encounters comprised 327 image-guided intratumoral investigational agent injections in 67 patients in clinical trials, including 33 patients with melanoma (50%), 14 patients with sarcoma (21%), 3 patients with ovarian cancer (4.5%), 2 patients with breast cancer (3%), and 2 patients with colon cancer (3%). An additional 18 patients with melanoma underwent 113 image-guided talimogene laherparepvec injections. There were no adverse events reported related to the technical component of the procedure, specifically needle insertion or biopsy. Serious adverse events (Common Terminology Criteria for Adverse Events score ≥3), including dyspnea and severe flu-like symptoms developing within 24 hours of the injection and requiring hospitalization, occurred after 3 of 327 investigational agent injections (2%) and 4 of 113 talimogene laherparepvec injections (4%). Conclusions and Relevance: The findings of this case series study suggest that intratumoral injections of immunotherapies were feasible across a range of histological conditions and target organs. Immediate postdelivery anticipated adverse events occurred in a small number of instances. Performing physicians should have the necessary safeguards in place to respond as needed. Optimal methods for intratumoral drug delivery remain unresolved, and efforts to standardize drug delivery techniques are required.

Intratumoral Hydrogen Peroxide With Radiation Therapy in Locally Advanced Breast Cancer: Results From a Phase 1 Clinical Trial.

PURPOSE: Hydrogen peroxide (H2O2) plays a vital role in normal cellular processes but at supraphysiological concentrations causes oxidative stress and cytotoxicity, a property that is potentially exploitable for the treatment of cancer in combination with radiation therapy (RT). We report the first phase 1 trial testing the safety and tolerability of intratumoral H2O2 + external beam RT as a novel combination in patients with breast cancer and exploratory plasma marker analyses investigating possible mechanisms of action. METHODS AND MATERIALS: Twelve patients with breast tumors ≥3 cm (surgically or medically inoperable) received intratumoral H2O2 with either 36 Gy in 6 twice-weekly fractions (n = 6) or 49.5 Gy in 18 daily fractions (n = 6) to the whole breast ± locoregional lymph nodes in a single-center, nonrandomized study. H2O2 was mixed in 1% sodium hyaluronate gel (final H2O2 concentration 0.5%) before administration to slow drug release and minimize local discomfort. The mixture was injected intratumorally under ultrasound guidance twice weekly 1 hour before RT. The primary endpoint was patient-reported maximum intratumoral pain intensity before and 24 hours postinjection. Secondary endpoints included grade ≥3 skin toxicity and tumor response by ultrasound. Blood samples were collected before, during, and at the end of treatment for cell-death and immune marker analysis. RESULTS: Compliance with H2O2 and RT was 100%. Five of 12 patients reported moderate pain after injection (grade 2 Common Terminology Criteria for Adverse Events v4.02) with median duration 60 minutes (interquartile range, 20-120 minutes). Skin toxicity was comparable to RT alone, with maintained partial/complete tumor response relative to baseline in 11 of 12 patients at last follow-up (median 12 months). Blood marker analysis highlighted significant associations of TRAIL, IL-1ß, IL-4, and MIP-1α with tumor response. CONCLUSIONS: Intratumoral H2O2 with RT is well tolerated with no additional toxicity compared with RT alone. If efficacy is confirmed in a randomized phase 2 trial, the approach has potential as a cost-effective radiation response enhancer in multiple cancer types in which locoregional control after RT alone remains poor.

Comparison of Treatment Outcomes after Collagenase Injection and Percutaneous Needle Fasciotomy for Dupuytren's Contracture: Objective and Subjective Comparisons with a 3-Year Follow-Up.

BACKGROUND: This study compared the effectiveness of injectable collagenase clostridium histolyticum and percutaneous needle fasciotomy in the treatment of Dupuytren's contracture. METHODS: Patients with a total passive extension deficit of 30 degrees or more in a single digital ray were enrolled and assigned randomly to receive either collagenase clostridium histolyticum injections or percutaneous needle fasciotomy. Preoperative severity of proximal interphalangeal joint contracture for Dupuytren's disease was classified according to the British Society for Surgery of the Hand as less than 30 degrees (stage I) or 30 degrees or more (stage II). RESULTS: Of the 70 patients enrolled, 36 patients with 46 joints received collagenase clostridium histolyticum injections and 34 patients with 48 joints received percutaneous needle fasciotomy. At day 30, successful corrections were obtained in only 50 percent of the injection group and 67 percent of the fasciotomy group for stage II proximal interphalangeal joints. Recurrences were frequent among patients with stage II joint contractures. The mean Quick Disabilities of the Arm, Shoulder and Hand questionnaire score at day 30 was significantly higher in the injection group compared with the fasciotomy group (7.5 versus 4.2, respectively). In the injection group, adverse events were reported for all patients. In the fasciotomy group, complications were reported for 15 percent of patients. CONCLUSIONS: The collagenase clostridium histolyticum and percutaneous needle fasciotomy groups had similar outcomes for Dupuytren's contracture with 3 years' follow-up. Recurrences were frequent among patients with stage II proximal interphalangeal joint contractures. The Unité Rhumatologique des Affections de la Main scale and Quick Disabilities of the Arm, Shoulder and Hand questionnaire score decreased significantly for both groups at final follow-up. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

Intralesional corticosteroid-induced hypopigmentation and atrophy.

Intralesional corticosteroids are associated with various, uncommon, local adverse events [1]. Atrophy and hypopigmentation most commonlyremain localized to sites of injection. However, outward radiation in a linear, streaky pattern has been reported and is termed "perilesional/perilymphatic hypopigmentation or atrophy [2]." We report a case of this rare adverse event.

Efficacy and tolerability of intralesional bleomycin in dermatology: A systematic review.

Bleomycin is widely used as an off-label treatment for various dermatologic indications. However, a much-needed critical appraisal of the currently available evidence is lacking. We therefore evaluated the quality of clinical evidence for the efficacy and safety of intralesional bleomycin treatment for dermatologic indications with the aim to provide evidence-based recommendations for clinical practice. The PubMed, Embase, Medline Ovid, Web of Science, Cochrane Central, and Google Scholar databases were systematically searched. Two authors independently selected relevant studies according to predefined inclusion and exclusion criteria. We assessed the methodologic quality with the Cochrane Collaboration risk-of-bias assessment tool and selected 10 randomized clinical trials and 15 clinical controlled trials. Treatment indications included common warts, nonmelanoma skin cancer, cutaneous metastases, keloid and hypertrophic scars, and hemangioma. Intralesional bleomycin treatment showed significantly higher cure rates for warts compared with other treatments. Local adverse events included erythema, blackening, eschar formation, and superficial ulceration. None of the studies reported systemic adverse events. Methodologic quality of the studies was generally low. Consequently, no firm recommendations can be made for intralesional bleomycin treatment in clinical practice. However, this review suggests that intralesional bleomycin is a successful and well-tolerated treatment for recalcitrant warts.