Efficacy and Safety of Topical Tranexamic Acid Alone or in Combination with Either Fractional Carbon Dioxide Laser or Microneedling for the Treatment of Melasma

Introduction: Tranexamic acid (TXA) is a promising treatment modality for melasma. Microneedling (MN) and fractional carbon dioxide (CO2) laser were reported to enhance TXA transepidermal delivery. Objectives: To compare efficacy and safety of topical TXA alone or in combination with either fractional CO2 laser or MN for treatment of melasma. Methods: Thirty females with facial melasma were divided randomly into 3 equal groups after excluding pregnant and lactating women and those using oral contraceptives or other hormonal therapy. Patients of group A were treated with fractional CO2 laser and those of group B were treated with MN (4 sessions, 3 weeks apart for both) with immediate topical application of TXA 5% solution after sessions and daily application of 5% TXA cream for both groups. Patients of group C were treated by topical daily application of TXA 5% cream. Evaluation was done by modified melasma area and severity index scores (mMASI), patient satisfaction and dermoscopy. Results: Statistically significant improvement of mMASI was reported in all studied groups with a significantly better improvement in patients of groups A and B than those of group C, meanwhile the difference between groups A and B was statistically insignificant. Conclusions: Topical TXA is a safe and fairly effective treatment modality for facial melasma. Combining TXA with either fractional CO2 laser or MN yielded significantly better improvement than when used alone. Fractional CO2 laser carries the risk of post-inflammatory hyperpigmentation in patients with skin types III and IV and requires meticulous patient selection

Evaluation of a quality improvement intervention to reduce anastomotic leak following right colectomy (EAGLE): pragmatic, batched stepped-wedge, cluster-randomized trial in 64 countries

Background Anastomotic leak affects 8 per cent of patients after right colectomy with a 10-fold increased risk of postoperative death. The EAGLE study aimed to develop and test whether an international, standardized quality improvement intervention could reduce anastomotic leaks. Methods The internationally intended protocol, iteratively co-developed by a multistage Delphi process, comprised an online educational module introducing risk stratification, an intraoperative checklist, and harmonized surgical techniques. Clusters (hospital teams) were randomized to one of three arms with varied sequences of intervention/data collection by a derived stepped-wedge batch design (at least 18 hospital teams per batch). Patients were blinded to the study allocation. Low- and middle-income country enrolment was encouraged. The primary outcome (assessed by intention to treat) was anastomotic leak rate, and subgroup analyses by module completion (at least 80 per cent of surgeons, high engagement; less than 50 per cent, low engagement) were preplanned. Results A total 355 hospital teams registered, with 332 from 64 countries (39.2 per cent low and middle income) included in the final analysis. The online modules were completed by half of the surgeons (2143 of 4411). The primary analysis included 3039 of the 3268 patients recruited (206 patients had no anastomosis and 23 were lost to follow-up), with anastomotic leaks arising before and after the intervention in 10.1 and 9.6 per cent respectively (adjusted OR 0.87, 95 per cent c.i. 0.59 to 1.30; P = 0.498). The proportion of surgeons completing the educational modules was an influence: the leak rate decreased from 12.2 per cent (61 of 500) before intervention to 5.1 per cent (24 of 473) after intervention in high-engagement centres (adjusted OR 0.36, 0.20 to 0.64; P < 0.001), but this was not observed in low-engagement hospitals (8.3 per cent (59 of 714) and 13.8 per cent (61 of 443) respectively; adjusted OR 2.09, 1.31 to 3.31). Conclusion Completion of globally available digital training by engaged teams can alter anastomotic leak rates. Registration number: NCT04270721 (http://www.clinicaltrials.gov)