Ann R Coll Surg Engl 2007; 89: 242-246 242Acceptable wound cosmesis and neck mobility are important outcomes following cervicotomy. Methods of skin closure vary in published series and are largely the result of surgeon choice based upon the need for a rapid, economic and reproducible technique of skin apposition. Recent advances in skin closure include the use of skin staples and tissue glues. Though each of these modalities has been evaluated against standard sutured methods in randomised clinical trials, no such comparison between these methods has been performed following cervicotomy. This blinded, randomised, controlled trial seeks to address this by comparing the speed and cosmetic results of cervicotomy closure using tissue glue or skin staples.
Patients and MethodsThe trial protocol was reviewed and approved by local research ethics committee. The study population comprised patients undergoing primary cervicotomy for thyroid or parathyroid surgery at a single district general hospital. Primary outcome measure was time taken to complete skin closure. A power calculation yielded that 30 participants were required based on a halving of closure time with 80% power, an allocation ratio of 1:1 to glue and staple groups and a two-sided significance test at the 5% level. Secondary outcomes were neck mobility, scar cosmesis score and perioperative adverse event rates. Inclusion criteria were planned primary thyroid or parathyroid surgery in patients of the age and ability to give informed consent, with no known allergies to the products to be used and agreeing to randomisation procedure. Exclusion criteria were secondary neck surgery, history of poor compliance with medical treatments, allergy to products to be used or inability to give informed consent for inclusion or randomisation. Potential participants were identified at outpatient visits when the decision for surgical excision was Cosmetic acceptability of scar and neck mobility are important outcomes after collar line incision for neck surgery. This randomised, controlled trial compares these parameters in closures using tissue glue (Dermabond™, Ethicon, UK) and skin staples.
HEAD AND NECK
e19542 Background: Non-Hodgkin’s lymphoma, specifically, diffuse large B-cell lymphoma (DLBCL) is most frequently diagnosed among older patients. The utilization of a reduced dose of cyclophosphamide, doxorubicin, vincristine, and prednisone (miniCHOP) chemotherapy-based regimen has an improved tolerance and toxicity profile in select patient populations. Prophylaxis with pegfilgrastim or its biosimilar pegfilgrastim-cbqv is administration on the same day of chemotherapy in all patients with MiniCHOP at The University of Arizona Cancer Center (UACC). We report here on the first study to address the safety and efficacy of same day pegfilgrastim administration in lymphoma patients receiving MiniCHOP. Methods: A retrospective, single center, cohort study was conducted at UACC between October 1, 2013 and October 2020 to evaluate lymphoma patients who were treated with miniR-CHOP and given pegfilgrastim or its biosimilar (pegfilgrastim-cbqv) for FN prophylaxis. The primary objective was to compare the incidence of FN across all cycles of chemotherapy and after the first cycle of chemotherapy in DLBCL patients on miniR-CHOP and provided with next-day versus same-day pegfilgrastim administration. Our secondary outcomes of interests were incidence of chemotherapy-induced neutropenia (CIN) grade 3/4; hospitalization; anti-biotics administration; and chemotherapy dose-reduction or delays. Results: A total of 100 cycles of miniR-CHOP were received, of these pegfilgrastim was administered on same-day of chemotherapy in 95 cycles and five cycles on the next-day of chemotherapy. Among all cycles the incidence of FN was 5.3% vs. 0.0 ( P= 1.00); CIN 3/4 was 10.5% vs. 0.0 ( P= 1.00); hospitalization was 10.5% vs. 20.0% ( P= 0.45), anti-biotics administration was 6.3% vs. 40.0% ( P= 0.05) and the chemotherapy dose delays or reductions was 16.8% vs. 0.0% ( P= 0.99). In the first cycle of chemotherapy, the incidence of FN was 14.3% vs. 0.0% ( P= 1.00), CIN 3/4 was 21.4% vs. 0.0 ( P= 1.00), hospitalization 28.6% vs. 25.0% ( P= 0.99), and the anti-biotics administration was 21.4% vs. 50.0% ( P= 0.53) for same-day vs. next-day study groups. Conclusions: In our analysis, we have shown that same-day pegfilgrastim or pegfilgrastim-cbqv was safe and effective in lymphoma patients receiving miniR-CHOP. There was no significant increase in FN or delayed engraftment in either group. Future prospective studies are warranted to address the safety and efficacy profile of same day pegfilgrastim or a pegfilgrastim biosimilars in elderly lymphoma patients.
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