Synthetic Electrospun Fiber Matrix in Abdominal Wall Donor Sites for Breast Reconstruction
A Prospective Pilot Study of Synthetic Electrospun Fiber Matrix in Abdominal Wall Donor Sites for Breast Reconstruction
This prospective single-arm pilot study will evaluate the application of meshed 5 × 7 cm Restrata® sheets to the abdominal wall donor site following deep inferior epigastric perforator (DIEP) or abdominal wall autologous free tissue transfer in 20 eligible patients.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Justin Sacks, MD, MBA, FACS
- Numero di telefono: 314-454-4894
- Email: jmsacks@wustl.edu
Luoghi di studio
-
-
Missouri
-
St Louis, Missouri, Stati Uniti, 63110
- Washington University School of Medicine
-
Contatto:
- Justin Sacks, MD, MBA, FACS
- Numero di telefono: 314-454-4894
- Email: jmsacks@wustl.edu
-
Investigatore principale:
- Justin Sacks, MD, MBA, FACS
-
Sub-investigatore:
- William Zhu, MD
-
Sub-investigatore:
- Terence Myckatyn, MD
-
Sub-investigatore:
- Gary Skolnick, MBA
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Scheduled for DIEP or abdominal wall autologous free tissue transfer procedure.
- At least 18 years of age.
- Karnofsky performance status ≤ 80%
- Ability to understand and willingness to sign an IRB approved written informed consent document.
Exclusion Criteria:
-
Current smoker.
-
Body mass index > 39.9.
-
Received systemic chemotherapy within 4 weeks prior to the scheduled DIEP or abdominal wall autologous free tissue transfer procedure.
-
Uncontrolled diabetes mellitus determined by the investigator.
*Note: if there is documentation of HgbA1c > 12% within 3 months of the scheduled DIEP or abdominal wall autologous free tissue transfer procedure, it will need to be reviewed by the PI to determine the patient's clinical situation and eligibility.
-
Pregnant.
-
Currently receiving any investigational agents.
-
Known sensitivity to resorbable sutures (polyglactin 910, polydioxanone).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Restrata® application
Patients undergoing standard of care deep inferior epigastric perforator (DIEP) or abdominal wall free tissue transfer procedure will have Restrata® sheets applied to the abdominal wall donor site following flap harvest. Patients will be followed for 12 months to assess outcomes. |
Restrata® is prepared in 5 x 7cm sheets and will be administered to the abdominal wall donor site following the flab harvest.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Rate of post-operative seroma, hematoma formation, or wound dehiscence within 6 weeks of procedure
Lasso di tempo: At time of procedure to 6 weeks after procedure (total estimated time: 6 weeks)
|
Clinical assessment of seroma formation will be conducted by the investigator through evaluation of the surgical site for the presence of swelling and/or fluid wave upon exam. Clinical assessment of hematoma formation and wound dehiscence will be conducted by the investigator through evaluation of the surgical site for the presence of swelling, discoloration, and firmness to the touch upon palpitation. Wound dehiscence is defined as separation of the margins of the closed surgical incision made in the skin, with or without exposure/protrusion of underlying tissue. |
At time of procedure to 6 weeks after procedure (total estimated time: 6 weeks)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Rate of post-operative infection
Lasso di tempo: At time of procedure until 3 months after procedure (total estimated time: 3 months)
|
Post-operative infection will be assessed via the occurrence of physiological symptoms including fever, pain, swelling, erythema, or seroma via clinical assessment. Post-operative infection will be summarized as absolute counts and as descriptive proportions along with corresponding 95% confidence intervals. |
At time of procedure until 3 months after procedure (total estimated time: 3 months)
|
|
Rate of post-operative wound dehiscence within 3 months of procedure
Lasso di tempo: At time of procedure until 3 months after procedure (total estimated time: 3 months)
|
Post-operative wound dehiscence will be determined via ultrasound and clinical assessment of the surgical site. Wound dehiscence is defined as separation of the margins of the closed surgical incision made in the skin, with or without exposure/protrusion of underlying tissue. Wound dehiscence will be summarized as absolute counts and as descriptive proportions along with corresponding 95% confidence intervals. |
At time of procedure until 3 months after procedure (total estimated time: 3 months)
|
|
Rate of unplanned re-operation at the donor site
Lasso di tempo: At time of procedure until 3 months after procedure (total estimated time: 3 months)
|
Incidence of unplanned reoperation of the donor site from the initial surgical procedure will be assessed as they occur and reported as absolute counts and descriptive proportions along with corresponding 95% confidence intervals. |
At time of procedure until 3 months after procedure (total estimated time: 3 months)
|
|
Drain output in cc
Lasso di tempo: At time of drain removal (total estimated time: 1-4 weeks)
|
Total drain output in cc will be reported as means with standard deviation if data is normally distributed and as medians with interquartile and absolute ranges if skewed. |
At time of drain removal (total estimated time: 1-4 weeks)
|
|
Time of transfer procedure to drain removal as assessed in days
Lasso di tempo: At time of procedure until time of drain removal (total estimated time 1-4 weeks)
|
Drains will be removed when output is less than 30 cc over 24 hours. Time of transfer procedure to drain removal in days will be reported as means with standard deviation if data is normally distributed and as medians with interquartile and absolute ranges if skewed. |
At time of procedure until time of drain removal (total estimated time 1-4 weeks)
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Justin Sacks, MD, MBA, FACS, Washington University School of Medicine
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 26-X358
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
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 .