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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Justin Sacks, MD, MBA, FACS
- Telefonnummer: 314-454-4894
- E-Mail: jmsacks@wustl.edu
Studienorte
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Missouri
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St Louis, Missouri, Vereinigte Staaten, 63110
- Washington University School of Medicine
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Kontakt:
- Justin Sacks, MD, MBA, FACS
- Telefonnummer: 314-454-4894
- E-Mail: jmsacks@wustl.edu
-
Hauptermittler:
- Justin Sacks, MD, MBA, FACS
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Unterermittler:
- William Zhu, MD
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Unterermittler:
- Terence Myckatyn, MD
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Unterermittler:
- Gary Skolnick, MBA
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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:
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Current smoker.
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Body mass index > 39.9.
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Received systemic chemotherapy within 4 weeks prior to the scheduled DIEP or abdominal wall autologous free tissue transfer procedure.
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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.
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Pregnant.
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Currently receiving any investigational agents.
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Known sensitivity to resorbable sutures (polyglactin 910, polydioxanone).
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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.
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Rate of post-operative seroma, hematoma formation, or wound dehiscence within 6 weeks of procedure
Zeitfenster: At time of procedure to 6 weeks after procedure (total estimated time: 6 weeks)
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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)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Rate of post-operative infection
Zeitfenster: 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)
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Rate of post-operative wound dehiscence within 3 months of procedure
Zeitfenster: At time of procedure until 3 months after procedure (total estimated time: 3 months)
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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)
|
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Rate of unplanned re-operation at the donor site
Zeitfenster: At time of procedure until 3 months after procedure (total estimated time: 3 months)
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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)
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Drain output in cc
Zeitfenster: At time of drain removal (total estimated time: 1-4 weeks)
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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)
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Time of transfer procedure to drain removal as assessed in days
Zeitfenster: At time of procedure until time of drain removal (total estimated time 1-4 weeks)
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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)
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Justin Sacks, MD, MBA, FACS, Washington University School of Medicine
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- 26-X358
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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