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Prevention of postoperative complications with negative pressure wound therapy after complex breast cancer surgery: a study protocol of a randomised controlled trial (TPN-SEIN)

Por: Neron · M. · Delmond · L. · Gourgou · S. · Delaine · S. · Chalbos · P. · Moussion · A. · Taoum · C.
Background

Complex breast surgery, including immediate breast reconstruction and oncoplastic procedures, is increasingly performed to optimise oncologic and aesthetic outcomes. Postoperative wound healing complications remain a major concern, particularly in high-risk patients. Negative pressure wound therapy (NPWT) has been shown to improve wound healing in various surgical fields. However, its effectiveness in oncologic breast surgery remains insufficiently studied. This study aims to evaluate the efficacy of NPWT in reducing wound healing complications in complex breast cancer surgery.

Methods

The TPN-SEIN study is a prospective, randomised, controlled, open-label, multicentre, phase III clinical trial. A total of 254 patients undergoing complex breast cancer surgery will be randomised either to arm 1 (NPWT immediately postoperatively for 7 days) or arm 2 (standard wound care). The primary endpoint is the rate of wound healing complications at day 30, defined as at least one of the following: deep postoperative infection of the prosthetic pocket, wound dehiscence or incomplete healing. Secondary endpoints include surgical site infection at day 90, reoperation rate, hospital readmission rate, time to complete healing, time to adjuvant treatment initiation, quality of life (European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire and breast cancer-specific quality of life questionnaire (QLQ-C30)), patient satisfaction and medico-economic outcomes.

Ethics and dissemination

The study was approved by the French national ethics committee (Comité de Protection des Personnes Est II, 5 December 2024, reference 24.04416.000295) and the institutional review board (IRB–COMERE, reference ICM-RCM 2024/11). The French National Agency for the Safety of Health Products has been notified. The study results will be presented at both national and international conferences and will also be published in a peer-reviewed journal.

Trial registration number

NCT06265558.

Nursing Care in Hospital Settings for Victims of Mental Disorders: Systematic Review With Meta‐Aggregation

ABSTRACT

Introduction

Approximately 25% of the Brazilian population suffers from mental disorders, a prevalence exacerbated by systemic and cultural factors such as socioeconomic inequalities, underfunded mental health services, regional disparities, and persistent stigma. These conditions significantly impact hospital care. Nurses, due to their direct contact with these patients, face challenges ranging from managing physical conditions to handling verbal aggression and psychiatric crises. This study aimed to assess the scientific evidence regarding nursing care for hospitalized patients with psychiatric disorders.

Methods

A systematic review with a mixed-methods approach was conducted, registered in PROSPERO (#CRD42022359288) and guided by PRISMA standards. Databases, such as MEDLINE, LILACS, PubMed, Web of Science, Scopus, and BDEnf, were searched using keywords like “Mental disorder,” “Psychiatric health,” “Nursing care,” and “Hospital.” Methodological quality was assessed using JBI and SQUIRE tools. The integration of quantitative and qualitative components occurred through meta-aggregation of qualitative data and frequency-based coding of quantitative themes, allowing thematic convergence across study designs.

Results

Six studies were included. Meta-aggregation revealed frequent terms, such as “Nurse,” “Emergency,” “Screening,” “Patient,” and “Care.” Similarity analysis linked “Nurse” with “perception” and “experience” and “Emergency” with “Screening” and “Mental health,” highlighting the importance of experience and training. Five categories emerged: (1) professional experience (19.05%, showing skill gaps despite experience); (2) caring process (19.05%, stressing efficient screening); (3) barriers and challenges (19.05%, revealing difficulty with comorbidities); (4) training process (19.05%, identifying training deficiencies); and (5) therapeutic interventions (23.81%, discussing restraint use). These percentages refer to the proportional frequency of themes identified across the total number of studies analyzed. For thematic classification, only statistically significant chi-square values (p < 0.05) were considered in the grouping of content.

Conclusion

Nursing care for psychiatric patients in hospitals faces challenges like insufficient training and difficulty managing psychiatric comorbidities. Recommendations include incorporating structured mental health content into nursing curricula and hospital-based continuing education programs. These strategies may guide future healthcare policies in Brazil by improving patient safety, reducing hospital readmissions, and promoting more humane, evidence-based therapeutic interventions.

Clinical Relevance

The findings emphasize the urgent need for targeted education and training to improve nursing care for psychiatric patients in hospital settings.

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