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Prospective Randomized Study Comparing Mastectomy Outcomes With Versus Without the Application of Autologous Blood Products to the Surgical Site

Phase 3
18 Years
Open (Enrolling)

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Trial Information

Prospective Randomized Study Comparing Mastectomy Outcomes With Versus Without the Application of Autologous Blood Products to the Surgical Site

A frequent complication of mastectomy is seroma formation with rates in the literature
reported at 3-50%. Although seroma formation can be considered more of a nuisance than a
serious complication, the presence of seroma can lead to wound infection, skin flap
necrosis, wound dehiscence, nerve injury, and lymphedema in mastectomy patients.Various
approaches to reduce seroma formation have included the use of external compression
dressings, ultrasound cutting devices, suction drainage systems, and bovine thrombin.
Although some of these interventions have demonstrated efficacy, none has gained widespread
acceptance. Investigation of alternative interventions during mastectomy procedures that
could reduce the rate of postoperative seroma formation, thereby reducing the likelihood of
the onset of more serious complications, still has value to the patient and surgeon. The use
of autologous blood products (ABP), in particular platelet rich plasma (PRP), has been
advocated for numerous indications. As a surgical tool, ABP are typically applied to the
surgical site during the latter stages of the procedure in combination with bovine thrombin.
The aim of PRP application is to accelerate the healing cascade via application of elevated
cytokine concentrations released during platelet degranulation. It is hypothesized that the
elevated cytokine levels will elucidate an accelerated healing response of the affected
tissue. Preliminary evidence suggests that this expedited healing response correlates with
a reduction in postoperative wound complications. Platelet poor plasma, a by-product of PRP
processing, has been advocated as providing additional hemostasis. The majority of the
literature discussing clinical applications of ABP to date, has been unblinded and
nonrandomized. Although useful as demonstrations of the safety of ABP, this current
literature does not truly investigate the efficacy of these applications. There is a need
for well-designed, well-controlled studies investigating the application of ABP as surgical
tools. It is hypothesized that a significant reduction in postoperative complications, in
particular seroma formation, will result due to the use of ABP during these procedures.

Inclusion Criteria:

1. Patient undergoing a modified radical mastectomy, simple mastectomy or axillary lymph
node dissection.

2. Patient signature of informed consent form

Exclusion Criteria:

1. Pregnancy

2. < 18 years of age

3. History of anemia (hemoglobin < 11.0)

4. History of any blood disorder, deep vein thrombosis, pulmonary emboli or clotting

5. Un-cooperative patient or patient with neurological disorders who are incapable of
following directions or who are predictably unwilling to return for follow-up

6. Allergy to bovine products

7. History of MRSA in last 12 months

8. Communicable disease or diseases that may limit follow- up (e.g. immunocompromised
conditions, hepatitis, active tuberculosis)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

Amount of Drainage during first 7 days postoperative. Drains will be removed during a follow-up visit to be held seven days postoperatively or when drainage is 30-35 ml in a 24 hour period, unless prohibited by complication.

Outcome Time Frame:

7 days

Safety Issue:


Principal Investigator

Shawn McKinney, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Physicians and Surgeons, Inc. d/b/a University Oncology Services


United States: Institutional Review Board

Study ID:




Start Date:

December 2008

Completion Date:

March 2012

Related Keywords:

  • Mastectomy
  • mastectomy
  • seroma
  • lymph node dissection



University Oncology Services at Edwards Comprehensive Cancer CenterHuntington, West Virginia  25701