Immediate Breast Reconstruction With Acellular Dermal Matrix

Breast Cancer Clinical Trial

Official title:

Comparison of One-stage Direct-to-implant With Acellular Dermal Matrix and Two-stage Implant-based Breast Reconstruction: A Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04209010
• Other study ID #: VEK 1-10-72-572-12
• Status: Completed
• Start date: December 1, 2012
• Est. completion date: March 17, 2016

Study information

• Verified date: January 2020
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The aim of this study is to contribute to the knowledge regarding immediate implant-based BR by investigating whether the one-stage technique with ADM is superior to the two-stage expander to implant technique. Primary endpoint in first publication is postoperative complications, secondary endpoint is patient and investigator assessed aesthetic outcome. Primary endpoint in second publication is cost, secondary endpoint is patient reported outcome measures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 17, 2016
• Est. primary completion date: March 17, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Skin sparing mastectomy due to breast cancer, ductal carcinoma in situ or high genetic risk of developing breast cancer

• Mastectomy weight = 600 g

• Patient older than 18 years

• Ability to complete the study questionnaire

• Only for the two-stage group no later than 2 years and 4 months from breast reconstruction

Exclusion Criteria:

• smokers

Related Conditions & MeSH terms

• Acellular Dermis
• Breast Cancer
• Breast Carcinoma in Situ
• Breast Neoplasms
• Carcinoma in Situ
• Mammaplasty

Intervention

Procedure:
• one-stage technique
breast reconstruction in one stage using silicone implant and acellular dermal matrix.

Locations

Country	Name	City	State
n/a

Sponsors (7)

Lead Sponsor	Collaborator
Aarhus University Hospital	Danish Cancer Society, Foundation of architect Holger Hjortenberg, Foundation of the Kjaersgaard Family, King Christian X foundation, LifeCell Corporation (Branchburg, NJ, USA), The Korning foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative complications	Major (requiring surgery - infection, hematoma, mastectomy flap necrosis). Obtained by review of patient chart.	3 months
Primary	Postoperative complications	Minor (not requiring surgery - seroma, cellulitis). Obtained by review of patient chart.	3 months
Secondary	Patient assessed satisfaction with aesthetic result	Assessment of result with and without clothes, symmetry and all-in-all satisfaction with result. Obtained by questionnaire on a 7 point Likert scale. Higher score equals higher satisfaction.	2 years
Secondary	Investigator assessed satisfaction with aesthetic result	Assessment of result with and without clothes, symmetry (including measurements of sternal notch-papil distance and papilla-inframammary fold distance). Obtained by clinical examination.	2 years
Secondary	Patient reported outcome measures	Patient reported assessment of pain and dysaesthesia in reconstructed breast, arm/shoulder function on reconstructed side. Described on a 6 point scale where lower score equals more pain/dysaesthesia/troubles with arm/shoulder function.; Body image (Hopwoods Body Image Scale) assessed in a 10-items each on 4 point Likert scale from 0 to 3. Sum provides a total score (range 0-30) and lower scores equals less body image troubles.; Furthermore, study specific questions as "use of pain killers the last week" (yes / no) and "all in all assessment of health owning to the breast reconstruction" (improved / diminished or unchanged). All obtained by questionnaire.	2 years
Secondary	Cost	cost analysis comparing the two methods regarding hospitalization, out patient visits, cost of expander/implant/acellular dermal matrix, surgical interventions.	2 years