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Completed

NCT Number: NCT04209010

Immediate Breast Reconstruction With Acellular Dermal Matrix

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.

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Key information

Conditions

Breast Cancer Acellular Dermis Breast Carcinoma In Situ Breast Diseases Breast Neoplasms Carcinoma Carcinoma in Situ Mammaplasty Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

one-stage technique

Procedure

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

Primary outcomes

  1. Postoperative complications

    Time frame: 3 months

    Major (requiring surgery - infection, hematoma, mastectomy flap necrosis). Obtained by review of patient chart.

  2. Postoperative complications

    Time frame: 3 months

    Minor (not requiring surgery - seroma, cellulitis). Obtained by review of patient chart.

Secondary outcomes

  1. Patient assessed satisfaction with aesthetic result

    Time frame: 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.

  2. Investigator assessed satisfaction with aesthetic result

    Time frame: 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.

  3. Patient reported outcome measures

    Time frame: 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.

  4. Cost

    Time frame: 2 years

    cost analysis comparing the two methods regarding hospitalization, out patient visits, cost of expander/implant/acellular dermal matrix, surgical interventions.

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Collaborators

  • 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

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Dec 23, 2019
Registry last updated
Jan 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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