[Posted 20/May/2022]

AUDIENCE: General Surgery, Oncology

KEY FINDINGS: Jet injectors generate a high number of small-droplet aerosols, potentially introducing harmful effects to patients and healthcare personnel. Room ventilation and smoke evacuation are effective safety measures when chemotherapeutics are used in clinical practice.

BACKGROUND: Needle-free jet injectors are frequently used in dermatological practice. Injection-generated small-droplet aerosols could be harmful upon inhalation when chemotherapeutics, like bleomycin, are used. Here, we aim to explore jet injector-induced small-droplet aerosol formation of bleomycin in relation to air ventilation and to provide safety measures for clinical practice.

DETAILS: With a professional particle sensor, during the study measured airborne aerosol particles (0.2-10. µm) after electronic pneumatic injection (EPI), spring-loaded jet injection (SLI), and needle injection (NI) of bleomycin and saline (100 µl) on ex vivo human skin. Three levels of air ventilation were explored: no ventilation, room ventilation, and room ventilation with an additional smoke evacuator. EPI and SLI induced significant small-droplet aerosol formation compared with none after NI (0.2-1.0 µm; no ventilation). The largest bleomycin aerosol generation was observed for the smallest particles (0.2-1.0 µm) with 673.170 (528.802-789.453) aerosol particles/liter air (EPI; no ventilation). Room ventilation and smoke evacuation led to a reduction of >=99% and 100% of measured aerosols, respectively.

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Source: Bik, L., Wolkerstorfer, A., Bekkers, V., et al. (2022). Needle-free Jet Injection-Induced Small-Droplet Aerosol Formation During Intralesional Bleomycin Therapy. Lasers Surg. Med.. 2022; 54(4): 572-579. Published: April, 2022. DOI: 10.1002/lsm.23512.

A Large Multisite Cohort Study

[Posted 6/Jun/2022]

AUDIENCE: General Surgery, Ob/Gyn

KEY FINDINGS: Although the risk for uterine perforation with IUD insertion 4 days to 6 weeks or less post partum is nearly seven times that of insertion non-post partum, perforation remains an incredibly rare event for all clinical time points. Despite a slight increased risk of perforation with breastfeeding at IUD insertion, the benefits of breastfeeding and effective contraception generally outweigh risks and should have little clinical impact. Therefore, IUD insertion timing should be based on individual desire for IUD contraception and patient convenience to assure an IUD insertion can occur. Careful follow-up of individuals at higher risk of uterine perforation is warranted.

BACKGROUND: Reports of perforation risk related to intrauterine devices (IUDs) inserted immediately post partum and among non-post-partum individuals are scarce, and previous studies with only 12-month follow-ups underestimate the risk. Breastfeeding at IUD insertion and insertion within 36 weeks post partum have been associated with increased risk of uterine perforation. The aim of these analyses was to compare the incidence and risks of IUD-related uterine perforations by non-post-partum and post-partum intervals at IUD insertion, and among post-partum individuals, to assess the impact of breastfeeding on these outcomes.

DETAILS: Performed a multisite cohort study in the USA, using electronic health records (EHR). Study sites were three health-care systems and a site that used data from a health-care information exchange. The study population included individuals who were aged 50 years or younger and had an IUD insertion between Jan 1, 2001, and April 30, 2018. Individuals were excluded if they had not been in the health-care system for at least 12 months before IUD insertion. The primary outcome for this analysis was any IUD-related uterine perforation diagnosis for the first IUD insertion in this time period. Both complete and partial IUD-related perforations were identified. Chart abstraction was done to validate EHR-based algorithms or confirm perforations. The crude rate and cumulative incidence of uterine perforation were evaluated by non-post-partum and post-partum intervals at IUD insertion in the full cohort, and by breastfeeding status in a subcohort of post-partum individuals. Cox models estimated crude and adjusted hazard ratios (aHRs). Data from 326,658 individuals in the full cohort and 94,817 individuals in the post-partum subcohort were analysed. In the full cohort, we identified 1008 uterine perforations (51.2% complete), with the 5-year cumulative incidence being the lowest in the non-post-partum group (0.29%, 95% CI 0.26-0.34). The aHR for the post-partum interval relative to non-post partum ranged from 2.73 (95% CI 1.33-5.63; 0 to 3 days post partum) to 6.71 (4.80-9.38; 4 days to >=6 weeks post partum). The post-partum subcohort of individuals with breastfeeding information had 673 uterine perforations (62% complete), with a 5-year cumulative incidence of 1.37% (95% CI 1.24-1.52) and an increased risk with breastfeeding (aHR 1.37, 95% CI 1.12-1.66).

Copyright © Elsevier Ltd. All rights reserved.

Source: Reed, S. D., Zhou, X., Ichikawa, L., et al. (2022). Intrauterine Device-related Uterine Perforation Incidence And Risk (Apex-Iud): A Large Multisite Cohort Study. The Lancet. 2022; 399(10341): 2103-2112. Published: June 4, 2022. DOI: 10.1016/S0140-6736(22)00015-0.

[Posted 28/Apr/2022]

AUDIENCE: General Surgery, Family Medicine

KEY FINDINGS: PBM improves sperm motility parameters by maintaining DNA and acrosome integrity and, therefore, represents a promising new tool for assisted reproductive therapy. In particular, improving sperm motility in asthenozoospermic patients by PBM in future may contribute to increasing the chance for successful intrauterine insemination. The present trial has no clinical registration number, as only in vitro studies were performed. The study was approved by the local ethics committee and performed according to the Declaration of Helsinki.

BACKGROUND: Previous studies reported that photobiomodulation (PBM) positively affects the mitochondrial respiratory chain in sperm, resulting in improved motility and velocity. As laser settings are not yet fully established, the present study aimed at optimizing PBM on human sperm. In addition, possible side-effects of PBM on sperm DNA fragmentation level and acrosomal integrity have been analyzed.

DETAILS: A pulsed laser-probe (wavelength 655 nm, output power 25 mW/cm², impulse duration 200 nanoseconds) was used. Native fresh liquefied semen samples underwent radiation with energy doses of 0 (control), 4, 6, and 10 J/cm². Sperm parameters were assessed at 0, 30, 60, 90, and 120 minutes after radiation using a computer-assisted sperm analysis system. Motility and velocity of sperm from asthenozoospermic patients (n = 42) and normozoospermic controls (n = 22) were measured. The amount of DNA strand breaks was analyzed using ligation-mediated quantitative polymerase chain reaction in patients with asthenozoospermia (n = 18) and normozoospermia (n = 13). Post-irradiance acrosomal integrity was investigated using flow cytometry based on CD46 protein expression (n = 7). Exposure to laser energy-doses of 4 and 6 J/cm² improved sperm motility and velocity in asthenozoospermic patients. PBM exhibited no significant effect on DNA fragmentation level and expression of CD46 serving as a biomarker for acrosome integrity.

Copyright © The Authors. Wiley Periodicals LLC. All rights reserved

Source: Espey, B. T., Kielwein, K., van der Ven, H., et al. (2022). Effects of Pulsed-Wave Photobiomodulation Therapy on Human Spermatozoa. Lasers Surg. Med.. 2022; 54(4): 540-553. Published: April, 2022. DOI: 10.1002/lsm.23399.

A Retrospective Matched Cohort Trial.

[Posted 15/Apr/2022]

AUDIENCE: General Surgery

KEY FINDINGS: The present study has shown that fully ablative CO2 laser debridement has several advantages over routine sharp surgical debridement. It is superior at ameliorating wound status and reducing wound area, and it also significantly reduces the time-to-heal for chronic wounds, without causing any adverse events.

BACKGROUND: Treating chronic cutaneous wounds is challenging, and debridement is a central concept in treating them. Studies have shown that CO₂> laser debridement can control local infection and promote the wound healing process. The present study aimed to investigate the efficacy and safety of fully ablative CO₂ laser debridement compared to routine surgical debridement in the treatment of chronic wounds.

DETAILS: The retrospective cohort study was conducted on patients with chronic (>1 month) cutaneous wounds (>=1 cm2) between December 1, 2017, and December 1, 2020, in the Wound Healing Center at Shanghai Ruijin Hospital, China. Patients treated with CO₂> laser debridement with a DEKA SmartXide2 C80 (DEKA) (the CO₂> laser group) were compared with matched control patients with similar baseline characteristics who had undergone routine surgical debridement (the routine group). The primary outcome was time-to-heal (days) for chronic wounds in two groups, and secondary outcomes included the wound area and BWAT (Bates-Jensen wound assessment tool) score before treatment, and at 1, 2, 3, and 4 weeks after treatment. The study included 164 patients (82 in the CO₂> laser group and 82 matched in the routine group). The time-to-heal for patients in the CO₂> laser group (41.30 ± 17.11) was significantly shorter than that of the patients in the routine group (48.51 ± 24.32) (p = 0.015). At 3 and 4 weeks after treatment, the absolute wound area of the CO₂> laser group was significantly smaller than that of the routine group. Also, the CO₂> laser group exhibited a significantly lower relative area at 2, 3, and 4 weeks after treatment. The CO₂> laser group yielded significantly lower BWAT scores at 2, 3, and 4 weeks after treatment. Additionally, the relative BWAT score was significantly lower in the CO₂> laser group than the relative scores in the routine group at 2, 3, and 4 weeks after treatment. No adverse events related to the treatments were observed in either group during the study period.

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Source: Guan, H., Zhang, D., Ma, X., et al. (2022). Efficacy and Safety of CO₂> Laser In The Treatment Of Chronic Wounds: A Retrospective Matched Cohort Trial. Lasers Surg. Med.. 2022; 54(4): 490-501. Published: April, 2022. DOI: 10.1002/lsm.23490.

Photobiomodulation Therapy For The Prevention Of Acute Radiation Dermatitis In Breast Cancer Patients Undergoing Hypofractioned Whole-Breast Irradiation (LABRA trial)

[Posted 29/Mar/2022]

AUDIENCE: General Surgery, Oncology, Ob/Gyn

KEY FINDINGS: Based on the LABRA trial results, PBM seems not able to reduce the incidence of severe ARD in breast cancer patients undergoing HF-WBI. Research in a larger patient population is recommended.

BACKGROUND: Purpose of this trial was to evaluate the efficacy of photobiomodulation therapy in breast cancer patients post-lumpectomy undergoing hypofractionated whole-breast irradiation (HF-WBI) for the prevention and management of acute radiodermatitis (ARD).

DETAILS: A randomized, multicentric clinical trial (LABRA trial, NCT03924011) was set up at the Limburg Oncology Center, including the Jessa Hospital (Hasselt, BE) and Ziekenhuis Oost-Limburg (Genk, BE). A total of 71 breast cancer patients planned to undergo HF-WBI were randomized to one of the two study arms: the control group (n = 32) or the PBM group (n = 39). The PBM group received the standard institutional skincare combined with PBM (2×/week) during the complete radiotherapy (RT) course. Patients in the control group received the standard skincare combined with placebo treatment (2x/week). Patients' skin reactions were evaluated weekly during the RT treatment by using the modified version of the Radiation Therapy Oncology Group (RTOG) criteria. At week 3 of RT, one patient presented a grade 2 and one patient a grade 3 skin reaction in the control group, while in the PBM group, all patients still presented grade 1 ARD. At the final RT session 28% of the patients presenting grade 2-3 ARD, while in the PBM group 10% presented grade 2 and no grade 3 ARD. PBM reduced the incidence of severe ARD by 18%. However, the difference was not significant (p = 0.053).

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Source: Robijns, J., Lodewijckx, J., Puts, S., et al. (2022). Photobiomodulation Therapy For The Prevention Of Acute Radiation Dermatitis In Breast Cancer Patients Undergoing Hypofractioned Whole-Breast Irradiation (LABRA trial). Lasers Surg. Med.. 2022; 54(3): 374-383. Published: March, 2022. DOI: 10.1002/lsm.23475.

Class I Recall - Because They Are Not Authorized, Cleared, or Approved by the FDA

[Posted 15/Mar/2022]

AUDIENCE: All Healthcare Professionals

ISSUE: LuSys Laboratories is recalling these tests because they do not have an Emergency Use Authorization, 510(k), or PMA and therefore cannot be legally marketed and distributed in the United States. In addition, LuSys Laboratories did not provide appropriate validation data to show that the tests can perform accurately. This means there is a risk of potential false negative, false positive, and misinterpretation of results from these tests. LuSys Laboratories has received no complaints or reports of injuries, deaths, or adverse events.

BACKGROUND:

• The LuSys Laboratories COVID-19 Antigen Test uses a nasal swab, or a saliva (spit) sample intended to detect proteins, called antigens, on the SARS-CoV-2 virus.
• The LuSys Laboratories COVID-19 IgG/IgM Antibody Test uses serum, plasma, or blood samples to look for antibodies produced by a person's immune system in response to SARS-CoV-2, the virus that causes COVID-19, suggesting a recent or previous infection.

RECOMMENDATIONS: On January 13, 2022, and January 24, 2022, LuSys Laboratories sent Urgent Medical Device Recall letters to device customers, distributors, and other U.S. consignees requesting them to take the following actions:

• Immediately stop using these tests.
• If the tests were distributed to third parties, immediately provide all consignees with a copy of this recall notification.
• Discard, destroy, or return all COVID-19 tests manufactured or distributed by LuSys Laboratories, Inc., a.k.a. Luscient Diagnostics LLC.

Source: FDA Recall - COVID-19 Antigen Tests (Nasal/Saliva) and COVID-19 IgG/IgM Antibody Tests by LuSys Laboratories. Published: March 14, 2022.