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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
-
-
Tennessee
-
Nashville, Tennessee, Forenede Stater, 37232-2345
- Vanderbilt University Medical Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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 undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / 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
|
|
Eksperimentel: Dermamatrix Arm
Arm which uses Dermamatrix as the lateral expander coverage
|
Dermamatrix used to cover lateral aspect of breast tissue expander after mastectomy
Andre navne:
|
Hvad måler undersøgelsen?
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
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Jason J. Wendel, M.D., Vanderbilt University
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 070415
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