The Use of an Acellular Dermal Matrix in a Two-Staged Breast Reconstruction
The Use of an Acellular Dermal Matrix in a Two-Staged Breast Reconstruction The Use of an Acellular Dermal Matrix in a Two-Staged Breast Reconstruction After Mastectomy: A Double-Blinded, Randomized Trial
This study intends to compare postoperative outcomes of a tissue expander placement following a mastectomy with two different operative techniques. This study will be randomized and double blinded comparing the traditional placement of the tissue expander under an inferolateral serratus muscle flap to a new technique which uses an acellular dermal matrix as an inferolateral sling, instead of the muscle flap.
The study we are proposing will evaluate the question of whether there is a difference between the traditional method of serratus flap and the new technique of using an acellular matrix with tissue expander placement. This will be a double blinded randomized study of thirty women in each group comparing outcomes which will include postoperative pain, complications (wound infection, hematoma, capsular contracture, etc), and patient satisfaction with the procedure.
Studieoversikt
Status
Studietype
Registrering (Faktiske)
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
-
-
Tennessee
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Nashville, Tennessee, Forente stater, 37232-2345
- Vanderbilt University Medical Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Patients presenting to Dr. Wendel's clinic who are older than 17 years of age undergoing a mastectomy and wish to have breast reconstruction with a tissue expander or those who have previously undergone a mastectomy and are now seeking reconstruction will be solicited for the study.
Exclusion Criteria:
- Preoperative radiation therapy
- Autoimmune disease
- Fever
- Uncontrolled diabetes mellitus
- Inability to comprehend or cooperate with postoperative instructions
- Local or systemic infection
- Have any allergies to the excipient ingredients found in the matrix
- Pregnancy
- Low vascularity of the surrounding tissue
- Mechanical trauma
- Poor nutrition
- Poor general medical condition
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Traditional Method
Arm which uses the Serratus Anterior muscle mobilization for lateral coverage of the tissue expander
|
Traditional use of serratus anterior for coverage of lateral aspect of tissue expander
|
|
Eksperimentell: Dermamatrix Arm
Arm which uses Dermamatrix as the lateral expander coverage
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Dermamatrix used to cover lateral aspect of breast tissue expander after mastectomy
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
postoperative pain
Tidsramme: perioperative up to 1 year
|
perioperative up to 1 year
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
aesthetic outcome
Tidsramme: 1 year
|
1 year
|
|
complications (infection, hematoma, capsular contracture)
Tidsramme: 1 year
|
1 year
|
|
Patient satisfaction
Tidsramme: 1 year
|
1 year
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Jason J. Wendel, M.D., Vanderbilt University
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 070415
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