Immediate Breast Reconstruction With Acellular Dermal Matrix

Sponsor

Aarhus University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04209010

Collaborator

Danish Cancer Society (Other), The Korning foundation (Other), Foundation of the Kjaersgaard Family (Other), King Christian X foundation (Other), Foundation of architect Holger Hjortenberg (Other), LifeCell Corporation (Branchburg, NJ, USA) (Other)

Enrollment

39.5

Actual Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Breast Carcinoma in Situ Mammaplasty Acellular Dermis	Procedure: one-stage technique

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

44 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 1, 2012

Actual Primary Completion Date :

Mar 17, 2016

Actual Study Completion Date :

Mar 17, 2016

Arms and Interventions

Arm	Intervention/Treatment
One-stage group Immediate implant based breast reconstruction after skin sparing mastectomy in one stage using silicone implant and acellular dermal matrix.	Procedure: one-stage technique breast reconstruction in one stage using silicone implant and acellular dermal matrix.
Two-stage group Immediate implant based breast reconstruction after skin sparing mastectomy in two stages using expander to silicone implant technique.

Arm

Intervention/Treatment

One-stage group

Immediate implant based breast reconstruction after skin sparing mastectomy in one stage using silicone implant and acellular dermal matrix.

Procedure: one-stage technique

breast reconstruction in one stage using silicone implant and acellular dermal matrix.

Two-stage group

Immediate implant based breast reconstruction after skin sparing mastectomy in two stages using expander to silicone implant technique.

Outcome Measures

Primary Outcome Measures

Postoperative complications [3 months]
Major (requiring surgery - infection, hematoma, mastectomy flap necrosis). Obtained by review of patient chart.
Postoperative complications [3 months]
Minor (not requiring surgery - seroma, cellulitis). Obtained by review of patient chart.

Secondary Outcome Measures

Patient assessed satisfaction with aesthetic result [2 years]
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.
Investigator assessed satisfaction with aesthetic result [2 years]
Assessment of result with and without clothes, symmetry (including measurements of sternal notch-papil distance and papilla-inframammary fold distance). Obtained by clinical examination.
Patient reported outcome measures [2 years]
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.
Cost [2 years]
cost analysis comparing the two methods regarding hospitalization, out patient visits, cost of expander/implant/acellular dermal matrix, surgical interventions.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

Principal Investigator: Mette Eline Brunbjerg, MD, Aarhus University Hospital, Aarhus University, Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mette Eline Brunbjerg, MD, MD, PhD student, Principal Investigator, Aarhus University Hospital

ClinicalTrials.gov Identifier:

NCT04209010

Other Study ID Numbers:

VEK 1-10-72-572-12

First Posted:

Dec 23, 2019

Last Update Posted:

Jan 3, 2020

Last Verified:

Jan 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Breast Neoplasms

Carcinoma in Situ

Breast Carcinoma In Situ

Study Results

No Results Posted as of Jan 3, 2020