Background Surgical site infection (SSI) is the most common postoperative complication worldwide. WHO guidelines to prevent SSI recommend alcoholic chlorhexidine skin preparation and fascial closure using triclosan-coated sutures, but called for assessment of both interventions in low-resource settings. This study aimed to test both interventions in low-income and middle-income countries.Methods FALCON was a 2 × 2 factorial, randomised controlled trial stratified by whether surgery was cleancontaminated, or contaminated or dirty, including patients undergoing abdominal surgery with a skin incision of 5 cm or greater. This trial was undertaken in 54 hospitals in seven countries (

Background: Several techniques and devices have been described for circumcision each with its own pros and cons. The objective of this study was to compare the outcome of neonatal circumcision between bone-cutter and plastibell devices at our institution. Methods: This is a randomized trial (unregistered) conducted at the Pediatric Surgical Unit of a tertiary teaching hospital situated in a semi-urban setting, between January 2019 and December 2019. The uncircumcised neonates underwent circumcision by either bone-cutter or plastibell device. Demographic characteristics, operative time, estimated blood loss, and postoperative complications were compared. A p-value of <0.05 was considered significant. Results: The age ranged between 7 days and 30 days with a mean of 15.9±5.5 days. The mean age and weight of both groups were well matched (p >0.05). The operative time in the bone cutter technique was 4.2±0.9 minutes compared to 5.8±1.2 minutes in the plastibell device method (p <0.001). Blood loss was lesser with bone cutter (0.27 ±0.32mls versus 0.51 ±0.44mls in the plastibell device, p <0.001). The complication rates were comparable in both study groups (p =1.000). The overall complication rate was 5.8%. The penile perception score and the Hollander wound evaluation score for bone-cutter were 15.7±0.8 and 5.7±0.84 while in the plastibell device were 15.4±1.1 and 5.4±1.1, respectively (p >0.05). Conclusion: Operative time and blood loss were less with bone cutter compared to plastibell device. However, the complication rate, penile perception score, and Hollander wound evaluation scores were similar.

Background The Bluebelle Wound Healing Questionnaire (WHQ) is a universal-reporter outcome measure developed in the UK for remote detection of surgical-site infection after abdominal surgery. This study aimed to explore cross-cultural equivalence, acceptability, and content validity of the WHQ for use across low- and middle-income countries, and to make recommendations for its adaptation. Methods This was a mixed-methods study within a trial (SWAT) embedded in an international randomized trial, conducted according to best practice guidelines, and co-produced with community and patient partners (TALON-1). Structured interviews and focus groups were used to gather data regarding cross-cultural, cross-contextual equivalence of the individual items and scale, and conduct a translatability assessment. Translation was completed into five languages in accordance with Mapi recommendations. Next, data from a prospective cohort (SWAT) were interpreted using Rasch analysis to explore scaling and measurement properties of the WHQ. Finally, qualitative and quantitative data were triangulated using a modified, exploratory, instrumental design model. Results In the qualitative phase, 10 structured interviews and six focus groups took place with a total of 47 investigators across six countries. Themes related to comprehension, response mapping, retrieval, and judgement were identified with rich cross-cultural insights. In the quantitative phase, an exploratory Rasch model was fitted to data from 537 patients (369 excluding extremes). Owing to the number of extreme (floor) values, the overall level of power was low. The single WHQ scale satisfied tests of unidimensionality, indicating validity of the ordinal total WHQ score. There was significant overall model misfit of five items (5, 9, 14, 15, 16) and local dependency in 11 item pairs. The person separation index was estimated as 0.48 suggesting weak discrimination between classes, whereas Cronbach’s α was high at 0.86. Triangulation of qualitative data with the Rasch analysis supported recommendations for cross-cultural adaptation of the WHQ items 1 (redness), 3 (clear fluid), 7 (deep wound opening), 10 (pain), 11 (fever), 15 (antibiotics), 16 (debridement), 18 (drainage), and 19 (reoperation). Changes to three item response categories (1, not at all; 2, a little; 3, a lot) were adopted for symptom items 1 to 10, and two categories (0, no; 1, yes) for item 11 (fever). Conclusion This study made recommendations for cross-cultural adaptation of the WHQ for use in global surgical research and practice, using co-produced mixed-methods data from three continents. Translations are now available for implementation into remote wound assessment pathways.

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