Protocol for a randomized controlled trial comparing wound COmplications in elective midline laparotomies after FAscia Closure using two different Techniques Of Running sutures: COFACTOR trial

Objective The first pediatric tracheostomy tube change often occurs within 7 days after placement; however, the optimal timing is not known. The primary objective was to determine the rate of adverse events of an early tube change. Secondary objectives compared rates of significant peristomal wounds, sedation requirements, and expedited intensive care discharges. Study Design Prospective randomized controlled trial. Setting Tertiary children’s hospital between October 2018 and April 2020. Methods A randomized controlled trial enrolled children under 24 months to early (day 4) or late (day 7) first tracheostomy tube changes. Results Sixteen children were enrolled with 10 randomized to an early change. Median age was 5.9 months (interquartile range, 5.4-8.3), and 86.7% required tracheostomy for respiratory failure. All tracheostomy tube changes were performed without adverse events. There were no accidental decannulations. Significant wounds developed in 10% of children with early tracheostomy tube changes and 83.3% of children with late tracheostomy tube changes (odds ratio [OR], 45.0; 95% CI, 2.3-885.6; P = .01). This significant reduction in wound complications justified concluding trial enrollment. Hours of dexmedetomidine sedation ( P = .11) and boluses of midazolam during the first 7 days ( P = .08) were no different between groups. After the first change, 90% of the early group were discharged from intensive care within 5 weeks compared to 33.3% of patients in the late group (OR, 18.0; 95% CI, 1.2-260.9; P = .03). Conclusion The first tracheostomy tube change in children can occur without adverse events on day 4, resulting in fewer significant peristomal wounds and earlier intensive care discharge.

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Effect of Stitch Length on Wound Complications After Closure of Midline Incisions: A Randomized Controlled Trial

Yearbook of Plastic and Aesthetic Surgery ◽

10.1016/s1535-1513(10)79560-6 ◽

2011 ◽

Vol 2011 ◽

pp. 244-245

Author(s):

G.C. Gurtner

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Wound Complications ◽

Randomized Controlled ◽

Stitch Length

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Negative-Pressure Wound Therapy Versus Standard Treatment of Adult Patients With Conflict-Related Extremity Wounds: Protocol for a Randomized Controlled Trial (Preprint)

10.2196/preprints.12334 ◽

2018 ◽

Author(s):

Andreas Älgå ◽

Sidney Wong ◽

Rawand Haweizy ◽

Kalle Conneryd Lundgren ◽

Johan von Schreeb ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Negative Pressure ◽

Negative Pressure Wound Therapy ◽

Standard Treatment ◽

Controlled Trial ◽

Treatment Strategies ◽

Wound Complications ◽

Wound Therapy ◽

Intention To Treat ◽

Randomized Controlled

BACKGROUND In armed conflict, injuries commonly affect the extremities and contamination with foreign material often increases the risk of infection. The use of negative-pressure wound therapy has been described in the treatment of acute conflict-related wounds, but reports are retrospective and with limited follow-up. OBJECTIVE The objective of this study is to investigate the effectiveness and safety of negative-pressure wound therapy use in the treatment of patients with conflict-related extremity wounds. METHODS This is a multisite, superiority, pragmatic randomized controlled trial. We are considering for inclusion patients 18 years of age and older who are presenting with a conflict-related extremity wound within 72 hours after injury. Patients are block randomly assigned to either negative-pressure wound therapy or standard treatment in a 1:1 ratio. The primary end point is wound closure by day 5. Secondary end points include length of stay, wound infection, sepsis, wound complications, death, and health-related quality of life. We will explore economic outcomes, including direct health care costs and cost effectiveness, in a substudy. Data are collected at baseline and at each dressing change, and participants are followed for up to 3 months. We will base the primary statistical analysis on intention-to-treat. RESULTS The trial is ongoing. Patient enrollment started in June 2015. We expect to publish findings from the trial by the end of 2019. CONCLUSIONS To the best of our knowledge, there has been no randomized trial of negative-pressure wound therapy in this context. We expect that our findings will increase the knowledge to establish best-treatment strategies. CLINICALTRIAL ClinicalTrials.gov NCT02444598; http://clinicaltrials.gov/ct2/show/NCT02444598 (Archived by WebCite at http://www.webcitation.org/72hjI2XNX) INTERNATIONAL REGISTERED REPOR DERR1-10.2196/12334

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