Breast Cancer Clinical Trial
— SAMOfficial title:
A Multi-center, Double Blinded Randomized Controlled Trial Evaluating Closure of the Dead Space After Mastectomy Using Sutures or Tissue Glue Versus Conventional Closure. Protocol for the Seroma Reduction After Mastectomy (SAM) Trial
Verified date | December 2019 |
Source | Zuyderland Medisch Centrum |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Rationale: Seroma formation and its sequelae form the mainstay of complications in breast
cancer surgery. Seroma has an incidence of 3% to 85%. Complications vary from delayed wound
healing, infection, skin flap necrosis, patient discomfort and repeated visits to the out
patient clinic. The key to reducing seroma formations seems to partly lie in the obliteration
of dead space. The use of electrocautery has been demonstrated to increase seroma formation
following mastectomy, however no other surgical devices (laser scalpel, argon diathermy and
ultrasonic scalpel) or substances have proven to be superior in seroma reduction.
No prospective randomized controlled trials have been able to demonstrate which techniques
are superior in reducing seroma and as a consequence patient discomfort in patients
undergoing mastectomy. In a previous retrospective observational study these investigators
demonstrated that mastectomy flap fixation significantly reduced seroma formation and the
number of seroma aspirations. In a pilot study that was recently performed in one of the
investigators hospitals, ARTISS tissue glue was used for skin flap fixation and showed
promising results. The investigators hypothesize that obliteration of the dead space
following mastectomy will significantly reduce seroma formation, its complications and the
discomfort it causes patients undergoing mastectomy.
Status | Completed |
Enrollment | 339 |
Est. completion date | August 31, 2019 |
Est. primary completion date | August 31, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Older than 18 years - Female sex - Indication for mastectomy or modified radical mastectomy Exclusion Criteria: - Patients undergoing breast conserving therapy - Patients undergoing direct breast reconstruction - Unable to comprehend implications and extent of study and sign for informed consent |
Country | Name | City | State |
---|---|---|---|
Netherlands | Zuyderland Medisch Centrum | Sittard | Limburg |
Lead Sponsor | Collaborator |
---|---|
Zuyderland Medisch Centrum |
Netherlands,
van Bastelaar J, Beckers A, Snoeijs M, Beets G, Vissers Y. Flap fixation reduces seroma in patients undergoing mastectomy: a significant implication for clinical practice. World J Surg Oncol. 2016 Mar 8;14:66. doi: 10.1186/s12957-016-0830-8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of seroma aspirations | Number of seroma aspirations performed post mastectomy | 1 year following surgery | |
Secondary | Number of out patient clinic visits | Number of out patient clinic visits | 1 year following surgery | |
Secondary | Infection rate | Post operative surgical site infections | 1 year following surgery | |
Secondary | Shoulder function | Shoulder function as measured by the disability of arm, shoulder and hand (DASH score) | 1 year following surgery | |
Secondary | Cosmesis | Subjective post operative cosmesis after mastectomy by questionnaire | 1 year following surgery | |
Secondary | Impact on Quality of life | QALY (EQ-5D) | 1 year following surgery | |
Secondary | Cost effectiveness | Cost effectiveness as assessed by a validated cost effectiveness questionnaire | 1 year following surgery |
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