Acellular Dermal Matrix in Breast Reconstruction Clinical Trial
Official title:
Comparing AlloDerm and DermACELL in Breast Reconstruction: A Randomized Laterality
Verified date | August 2022 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will compare 90-day complication rates between breasts reconstructed with tissue expanders and AlloDerm vs. DermACELL, with each patient serving as her own comparator.
Status | Completed |
Enrollment | 50 |
Est. completion date | July 26, 2022 |
Est. primary completion date | July 26, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Female patients over the age of 18 - May be undergoing either therapeutic or prophylactic mastectomy - Must be undergoing bilateral mastectomy and breast reconstruction with tissue expanders Exclusion Criteria: - Patients who wish to avoid the use of ADM in their reconstruction - History of radiation of the breast - Unilateral mastectomies - Direct to implant breast reconstruction (not utilizing a tissue expander) |
Country | Name | City | State |
---|---|---|---|
United States | DAVinci Plastic Surgery | Washington | District of Columbia |
United States | Sibley Memorial Hospital | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University |
United States,
Pittman TA, Fan KL, Knapp A, Frantz S, Spear SL. Comparison of Different Acellular Dermal Matrices in Breast Reconstruction: The 50/50 Study. Plast Reconstr Surg. 2017 Mar;139(3):521-528. doi: 10.1097/PRS.0000000000003048. — View Citation
Steiner CA, Weiss AJ, Barrett ML, Fingar KR, Davis PH. Trends in Bilateral and Unilateral Mastectomies in Hospital Inpatient and Ambulatory Settings, 2005-2013. 2016 Feb [updated 2016 Mar 1]. Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Statistical Brief #201. Available from http://www.ncbi.nlm.nih.gov/books/NBK367629/ — View Citation
Zenn MR, Salzberg CA. A Direct Comparison of Alloderm-Ready to Use (RTU) and DermACELL in Immediate Breast Implant Reconstruction. Eplasty. 2016 Aug 11;16:e23. eCollection 2016. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Drain time | Number of days between surgical placement of drains and time until drains are removed. | Up to 90 days | |
Primary | Drain output | Total amount of fluid collected by the drains until their removal (measured in cc). | Up to 90 days | |
Primary | Incidence of Seroma | Each patient will be evaluated for incidence of seroma in either breast at postoperative visits. | Up to 90 days | |
Primary | Incidence of Infection | Each patient will be evaluated for incidence of infection in either breast at postoperative visits. | Up to 90 days | |
Secondary | Incidence of Skin necrosis | Each patient will be evaluated for skin necrosis of either breast at postoperative visits. | Up to 90 days | |
Secondary | Incidence of Hematoma | Each patient will be evaluated for incidence of hematoma in either breast at postoperative visits. | Up to 90 days | |
Secondary | Incidence of Device Explantation | If patients require device explantation in one breast due to complications (e.g. infection). | Up to 90 days |