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Drain-Less Abdominally Based Breast Reconstruction Using Lysine-Derived Urethane Adhesive

20 novembre 2020 aggiornato da: Case Comprehensive Cancer Center

Drain-Less Abdominally Based Breast Reconstruction Using a Novel Lysine-Derived Urethane Adhesive (TissueGlu, Cohera Medical)

Drains are routinely utilized in breast reconstruction when using abdominal tissue of the patient to remove fluid buildup while the body heals after surgery. However, drains are associated with patient discomfort, anxiety, decreased mobility, increased hospital stays and outpatient visits. Drains can also serve as a site of origin for infection as the system is not completely closed, and infectious organisms could theoretically use the drain as point of entry.

This proposed study investigates a potential novel mechanism to prevent the development of seromas (pockets of clear fluid which can develop after surgery) in patients who undergo breast reconstruction with their own abdominal tissue. By eliminating the required use of a drain, the study team expects patients to have less pain and use less pain medication, as well as more satisfaction with their overall surgical experience.

Panoramica dello studio

Stato

Ritirato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Objectives:

  1. Establish the safety of a lysine-derived urethane adhesive (TissuGlu, Cohera Medical) in patients undergoing autologous abdominal-based breast reconstruction. This will be assessed via analyzing complication profiles of patients post-operatively. The primary endpoints are rate of seroma development, need for seroma drainage and time to drain removal (if in drain group).
  2. Determine if there is a difference in pain and other quality of life measures when comparing patients who do and do not have abdominal drains. This will be assessed via pain medicine utilization and by delivering a targeted survey pre-operatively, as well as at post-operative day three and four weeks.

Study Design:

Patients will be randomized to one of three arms: 1) Traditional closed-suction drains, 2) TissuGlu with closed-suction drains and 3) TissuGlu without closed-suction drains.

Tipo di studio

Interventistico

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 22 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Patients undergoing Abdominally-Based Breast Reconstruction

    • Both unilateral or bilateral reconstruction is allowed
  • Both delayed or immediate reconstruction is allowed

Exclusion Criteria:

  • Diabetes
  • BMI>30
  • Active smokers.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Tissue Glu with drains
This is standard of care to use Tissue Glu in addition to a drain. Pre-operatively, as well as on post-operative patients will be asked to complete a questionnaire that addresses their pain, impact of drains on activities of daily living, social and physical activities. Patients will also be asked to provide information regarding who is caring for the drains, the impact of drains on the caregiver, the amount of anxiety the patient has related to drain removal and the amount of pain associated with drain removal
Dispositivo: Tissue Glu
Once adequate hemostasis has been achieved during surgery and the abdominal fascia and flaps have been irrigated, Tissue Glu will be applied. Tissue Glu is applied at approximately one centimeter intervals while remaining one centimeter away from the umbilicus and inferior incisions.
Altri nomi:
  • TissuGlu
  • lysine-derived urethane adhesive
Dispositivo: Drain
Drains will be placed during surgery to allow for the drainage of seroma which may develop after surgery
Altri nomi:
  • closed-suction drains
Altro: Questionnaires
Questionnaires given to patients pre-and post surgery to determine pain, impact of breast reconstruction on activity, and impact of breast reconstruction on caregivers
Sperimentale: Tissue Glu without drains
This group utilizes Tissue Glu without the presence of a drain. Pre-operatively, as well as on post-operative patients will be asked to complete a questionnaire that addresses their pain, impact of drains on activities of daily living, social and physical activities. Patients will also be asked to provide information regarding who is caring for the drains, the impact of drains on the caregiver, the amount of anxiety the patient has related to drain removal and the amount of pain associated with drain removal
Dispositivo: Tissue Glu
Once adequate hemostasis has been achieved during surgery and the abdominal fascia and flaps have been irrigated, Tissue Glu will be applied. Tissue Glu is applied at approximately one centimeter intervals while remaining one centimeter away from the umbilicus and inferior incisions.
Altri nomi:
  • TissuGlu
  • lysine-derived urethane adhesive
Altro: Questionnaires
Questionnaires given to patients pre-and post surgery to determine pain, impact of breast reconstruction on activity, and impact of breast reconstruction on caregivers
Comparatore attivo: Drains
This is standard of care to use traditional closed-suction drains. Pre-operatively, as well as on post-operative patients will be asked to complete a questionnaire that addresses their pain, impact of drains on activities of daily living, social and physical activities. Patients will also be asked to provide information regarding who is caring for the drains, the impact of drains on the caregiver, the amount of anxiety the patient has related to drain removal and the amount of pain associated with drain removal
Dispositivo: Drain
Drains will be placed during surgery to allow for the drainage of seroma which may develop after surgery
Altri nomi:
  • closed-suction drains
Altro: Questionnaires
Questionnaires given to patients pre-and post surgery to determine pain, impact of breast reconstruction on activity, and impact of breast reconstruction on caregivers

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Rate of seroma development
Lasso di tempo: Up to 30 days after surgery
Number of seromas which develop during the first 30 days after surgery.
Up to 30 days after surgery

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Difference in pain between patients with and without abdominal drains
Lasso di tempo: Up to 4 weeks after surgery
Patients will be given a questionnaire pre-operatively and the same questionnaire post-operatively. The change in these questionnaires will be compared between groups
Up to 4 weeks after surgery
Pain Medicine Utilization
Lasso di tempo: Up to 4 weeks after surgery
Use of pain medicine after surgery between groups, as indicated by chart review
Up to 4 weeks after surgery
Time to drain removal
Lasso di tempo: Up to 4 weeks after surgery
Time from surgery to the removal of the drain for any reason, in patients who were given a drain
Up to 4 weeks after surgery

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Case Comprehensive Cancer Center

Investigatori

  • Investigatore principale: Andrea Moreira, MD, Cleveland Clinic, Case Comprehensive Cancer Center

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Anticipato)

1 novembre 2020

Completamento primario (Anticipato)

1 febbraio 2021

Completamento dello studio (Anticipato)

1 settembre 2021

Date di iscrizione allo studio

Primo inviato

17 maggio 2017

Primo inviato che soddisfa i criteri di controllo qualità

17 maggio 2017

Primo Inserito (Effettivo)

18 maggio 2017

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

24 novembre 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 novembre 2020

Ultimo verificato

1 novembre 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CASE5117

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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