Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06774755

Reconstructions of Chest Wall Defects: a Retrospective Study

Patients requiring thoracic reconstruction often suffer from numerous comorbidities, such as obesity, diabetes, atherosclerosis and cardiovascular diseases, respiratory diseases. The clinical picture of these patients must be carefully stabilized in the preoperative period since the listed diseases are associated with a poor reconstructive outcome. Furthermore, it is necessary to preoperatively determine the spirometric characteristics in cases where the intervention may alter the respiratory dynamics to evaluate the patient's ability to tolerate the procedure. The primary objective of the study is to identify the best diagnostic-therapeutic approach in cases of complex chest wall defects, retrospectively evaluating the outcomes and therapeutic choices implemented, through a reassessment of the interventions performed and the clinical progress of patients undergoing complex thoracic and sternal reconstruction interventions managed in a multidisciplinary and non-multidisciplinary manner

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Chest Wall Deformity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS AOU di Bologna Policlinico di Sant'Orsola

Bologna, 40138, Italy

Location status: Recruiting

Location contact

Marco Pignatti, MD

CONTACT

[email protected]

+390512143614

About this study

Currently there are no univocal universally accepted guidelines regarding the intervention to be performed in case of complex chest wall reconstructions or for the treatment of sternal wound dehiscences. Different options are described, both for the demolition phase and for the reconstructive phase in the thoracic and sternal area. The choice of one method rather than the other is currently largely based on the experience and preference of the specific working group. The importance of the study lies in the attempt to analyze the choices made in the diagnostic and therapeutic phase (demolitive, reconstructive, pharmacological) on patients treated at the AOU Sant'Orsola (now IRCCS) in past years. The secondary objective of the study is to improve the multidisciplinary management of patients who are candidates for complex chest reconstructions.

In particular, the drafting of a multidisciplinary therapeutic protocol that uses algorithms to optimize the choice of surgical procedure and medical therapy in terms of resolution of the problem, hospitalization times, and patient quality of life.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients undergoing sternal or thoracic reconstruction in collaboration or not with the Reconstructive Plastic Surgery Unit
  • Obtaining informed consent

Exclusion criteria

-

Treatment and study plan

Primary outcomes

  1. Technical Success

    Time frame: From the first patient enrolled, up to the 100th patient

    Thechnical success is evaluated by duration of surgery, complications and need for reoperation, and hospitalization time

Study contacts

Contact information is provided by the study sponsor or research team.

Marco Pignatti, MD

CONTACT

[email protected]

+390512143614

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Acronym: PLAST-CHEST

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 14, 2025
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.