One-stage Breast Reconstruction Using Dermal Matrix/Implant Versus Two-stage Expander/Implant Procedure

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: Two-stage tissue expander/implant procedure; Procedure: One-stage dermal matrix/implant procedure

• Registration Number: NCT00956384
• Lead Sponsor: University Health Network, Toronto

Brief Summary

Currently the two-stage tissue expander/implant (TE/I) technique is the standard breast reconstructive option for breast cancer patients selected for immediate, skin-sparing mastectomy. This procedure has been demonstrated to be oncologically safe in patients with specific criteria for early stage breast cancer. The primary drawback, however, is that it requires two separate procedures under general anesthesia and multiple office visits for expander inflation to create the breast mound. Acellular dermal matrix has gained widespread acceptance for use in breast reconstruction and other areas and has the potential to provide support to the breast implant without tissue expansion in a one-stage procedure. The purpose of the study is to test this new procedure and to evaluate the impact of one-stage breast reconstruction using acellular dermis compared to the standard two-stage expander/implant technique on measures of patient satisfaction and quality of life.

Detailed Description

Recently, there has been significant focus on the performance of skin-sparing mastectomies in certain types of breast cancer patients. These treatments may be performed for prophylactic mastectomy but also have been demonstrated to be oncologically safe in patients with specific criteria for early stage breast cancer. Currently, the two-stage tissue expander/implant (TE/I) technique is the standard breast reconstructive option for breast cancer patients selected for immediate, skin-sparing mastectomy, however there are significant disadvantages as this technique requires two separate surgeries and multiple office visits to complete that may affect a patients quality of life. Medically safe compounds such as acellular dermal matrix have been developed that have the potential to support breast implants without requiring numerous tissue expansions and consequently providing the potential for a one-stage breast implant/reconstruction procedure for immediate, skin-sparing mastectomies.

To examine patient satisfaction, quality of life and overall aesthetic outcome achieved using the acellular dermal matrix facilitated one-staged breast reconstruction at 2 weeks, 6 \& 12 months following completion of the reconstruction. Hypothesis 2: Patient satisfaction, quality of life and overall aesthetic outcome achieved using the acellular dermal matrix facilitated one-stage breast reconstruction is superior to that following the standard two-stage tissue expander/ implant breast reconstruction technique in selected mastectomy patients.

To determine the short and long-term operative complication rates associated with the use of dermal matrix in one-stage immediate breast reconstruction following skin-sparing mastectomy. Hypothesis 1: The use of acellular dermal matrix in one-stage immediate prosthetic breast reconstruction is associated with decreased short and long-term postoperative complications compared with the traditional two staged tissue expander/implant procedure.

Study Timeline

• Study First Submitted: 2009-08-07
• Study First Submitted QC: 2009-08-10
• Study First Posted: 2009-08-11
• Study Start: 2009-09-01
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Results First Submitted: 2020-07-09
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-17
• Last Update Submitted: 2024-10-17
• Results First Posted: 2024-12-05
• Last Update Posted: 2024-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 198

Inclusion Criteria

• Patients who undergo immediate, implant-based reconstruction following skin-sparing and nipple-sparing mastectomy.
• Patients who are older than 18 years of age and who understand English enough to complete the study questionnaires.

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Exclusion Criteria

• Patient refusal, patients with documented psychiatric history of psychosis or mental disorder excluding depression, patients who are active smokers.
• Patients who will undergo any of the following: Autologous tissue reconstruction, patients with prior history of radiation or expected to receive post-operative radiation, patients who are pregnant, patients with grade III ptosis.
• Intraoperative exclusion of those whose mastectomy flaps are deemed to be too thin or have significant ischemia.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Two-stage tissue expander/implant	Two-stage tissue expander/implant procedure	Two-stage breast reconstruction with tissue expander and implant
One-stage dermal matrix/implant	One-stage dermal matrix/implant procedure	One-stage breast reconstruction with dermal matrix and implant

Primary Outcome Measures

Name	Time	Method
BreastQ Quality of Life and Satisfaction Questionnaire	12 months post-op	Compare the change in the patient satisfaction and QOL scores between one-stage ADM-assisted and two-stage TE/I reconstruction without ADM over time (at 2 weeks after mastectomy, at 6 months and at 12 months following the final reconstruction procedure) from baseline scores following reconstruction using the validated BREAST-Q reconstruction module.; The BREAST-Q Reconstruction Module is used to measure outcomes across four domains/sub-scales: satisfaction with the breast, psychosocial wellbeing, physical wellbeing, and sexual wellbeing. Each domain is scored on a scale of 1 to 100, with higher scores indicating better quality of life and greater patient satisfaction with more favorable outcomes.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Short Term Surgical Complications	6- months post-op	Short complication rates were collected prospectively on intraoperative and postoperative assessment forms. Short-term complications were those that occur intraoperatively or within the first 2 months of surgery
Number of Participants With Long Term Surgical Complications	12 months post-op	Long-term minor and major surgical complication rates were documented and collected prospectively on intraoperative and postoperative assessment form at 12-months follow-up visit

Trial Locations

Locations (4)

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Tom Baker Cancer Centre; 🇨🇦 Calgary, Alberta, Canada

Plastic Surgery, Women's College Hospital; 🇨🇦 Toronto, Ontario, Canada

Plastic and Reconstructive Surgery, University Health Network; 🇨🇦 Toronto, Ontario, Canada