MastectomyPhase 3NCT00802477
Application Of Autologous Blood Products During Modified Radical Mastectomy
A Phase 3 study testing Application of autologous blood products. and Standard Modified Radical Mastectomy in people with Mastectomy, run by Marshall University at 1 site in United States.
Trial summary
The purpose of this study is to determine if the application of autologous (your own blood) blood products during mastectomy improves wound healing and decreases complications following surgery compared to mastectomy without the use of autologous blood products. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mastectomy
- What is being tested?
- Application of autologous blood products. and Standard Modified Radical Mastectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Mar 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient undergoing a modified radical mastectomy, simple mastectomy or axillary lymph node dissection.
- Patient signature of informed consent form
Who cannot join
- Pregnancy
- < 18 years of age
- History of anemia (hemoglobin < 11.0)
- History of any blood disorder, deep vein thrombosis, pulmonary emboli or clotting disorders.
- Un-cooperative patient or patient with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations
- Allergy to bovine products
- History of MRSA in last 12 months
- Communicable disease or diseases that may limit follow- up (e.g. immunocompromised conditions, hepatitis, active tuberculosis)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University Oncology Services at Edwards Comprehensive Cancer Center
Huntington, West Virginia, 25701
Leann Ross, RN, 304-399-6617, leann.ross@chhi.org
Shawn McKinney, MD
About this study
Official title: Prospective Randomized Study Comparing Mastectomy Outcomes With Versus Without the Application of Autologous Blood Products to the Surgical Site
The purpose of this study is to determine if the application of autologous (your own blood) blood products during mastectomy improves wound healing and decreases complications following surgery compared to mastectomy without the use of autologous blood products.
Read the detailed description
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.
- Conditions
- Mastectomy
- Being tested
- Application of autologous blood products., Standard Modified Radical Mastectomy
- Keywords
- mastectomy, seroma, lymph node dissection
- Medical subject headings
- Seroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of autologous blood products.Procedure or surgery
Autologous blood products (platelet rich and platelet poor plasma) produced by the PlasmaxTM Plus Plasma Concentration System will be applied to the surgical site.
Standard Modified Radical MastectomyProcedure or surgery
Mastectomy per standard procedure without the application of autologous blood products.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Application of Autologous Blood Products to surgical site during mastectomy. Receives: Procedure: Application of autologous blood products. |
| 2 | Active comparator | Standard Modified Radical Mastectomy Receives: Procedure: Standard Modified Radical Mastectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Secondary outcomes (1)
The secondary endpoint for this study will be the rate of patients experiencing at least one of the following postoperative wound complications: 1. Seroma Formation 2. Surgical Site Infection
Measured: 6 weeks post -op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionJan 2012 (estimated)
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MastectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marshall University
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet, Cabell Huntington Hospital
- Investigators
- Shawn McKinney, MD, Principal investigator, University Physicians and Surgeons, Inc. d/b/a University Oncology Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00802477
- Sponsor's protocol ID
- MU9339
- Status last verified
- Jul 2011
- First submitted
- 4 Dec 2008
- Last updated
- 1 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study Comparing Mastectomy Outcomes With Versus Without the Application of Autologous Blood Products to the Surgical Site
- ClinicalTrials.gov ID
- NCT00802477
- Acronym / sponsor ID
- MU9339
- Conditions
- Mastectomy
- Keywords
- mastectomy, seroma, lymph node dissection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Marshall UniversityUniversity, hospital or other
- Collaborators
- Zimmer Biomet, Cabell Huntington Hospital
- Study start
- Dec 2008
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 5 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if the application of autologous (your own blood) blood products during mastectomy improves wound healing and decreases complications following surgery compared to mastectomy without the use of autologous blood products.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Application of autologous blood products.Application of Autologous Blood Products to surgical site during mastectomy. |
| 2 | Active comparator | Procedure: Standard Modified Radical MastectomyStandard Modified Radical Mastectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient undergoing a modified radical mastectomy, simple mastectomy or axillary lymph node dissection.
- Patient signature of informed consent form
Key exclusion criteria (8 listed)
- Pregnancy
- < 18 years of age
- History of anemia (hemoglobin < 11.0)
- History of any blood disorder, deep vein thrombosis, pulmonary emboli or clotting disorders.
- Un-cooperative patient or patient with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Application of autologous blood products.Autologous blood products (platelet rich and platelet poor plasma) produced by the PlasmaxTM Plus Plasma Concentration System will be applied to the surgical site. | Procedure or surgery | 1 |
| Standard Modified Radical MastectomyMastectomy per standard procedure without the application of autologous blood products. | Procedure or surgery | 2 |
Primary outcome
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.
Time frame: 7 days
1 secondary outcome
The secondary endpoint for this study will be the rate of patients experiencing at least one of the following postoperative wound complications: 1. Seroma Formation 2. Surgical Site Infection
Time frame: 6 weeks post -op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2011.
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Wound Healing
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shawn McKinney, MD principal investigator
University Physicians and Surgeons, Inc. d/b/a University Oncology Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Application of autologous blood products. and Standard Modified Radical Mastectomy in people with Mastectomy, run by Marshall University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact GiGi Gerlach, RN (304-399-3386, gigi.gerlach@chhi.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary 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. (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2011.