Clinical trial NCT01509781: Suction Drain Versus the Use of Adaptive Skin Sutures After Mastectomy ± Axillary Lymphadenectomy; a Prospective Randomised Study
Official title: Optimal Wound Care After Simplex or Modified Radical Mastectomy With or Without Axillary Lymphadenectomy Placement of a Drain Versus the Use of Adaptive Skin Sutures; a Prospective Randomised Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: in Situ Breast Cancer
Invasive Breast Cancer
Keywords: simple mastectomy
modified radical mastectomy
wound care
suction drain
adaptive suture
Lead sponsor: National Institute of Oncology, Hungary
Sponsor class: OTHER
First posted: 2012-01-13
Enrollment: 400
Sex: FEMALE
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective of this prospective randomized study is to perform qualitative and quantitative comparisons between the insertion of traditional suction drains (Arm: Suction drain) versus the application of absorbable adaptive sutures (Arm: Adaptive suture) following simplex mastectomy or modified radical mastectomy in the light of the total volume of withdrawn serum from wound cavity, the extent of early postoperative analgesic requirements and quality of life.


Eligibility criteria: Inclusion Criteria:

* female patients with primary unilateral, stage 0, I or II, T3N1M0 breast cancer necessitating simple or modified radical mastectomy

Exclusion Criteria:

* age above 75 years and bad general state
* pregnancy
* autoimmune disease
* non-radical excision
* mastitis carcinomatosis
* lymphangitis carcinomatosis
* wound infection necessitating treatment

Primary outcomes:
measure: Total amount of sera withdrawn from the wound cavity
timeFrame: 4 weeks
Secondary outcomes:
measure: Extent of early postoperative analgesic requirements
timeFrame: 4 days
measure: Number of punctions following the removal of suction drain, and total volume of punctuated seroma (mL)
timeFrame: 4 weeks
measure: Rate of local wound complications.
timeFrame: 4 weeks
measure: Assessment of quality of life in the early postoperative period
timeFrame: 4 weeks
measure: Mobility of the shoulder on the side of the operated side
timeFrame: 4 weeks
measure: Cost analysis
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: National Institute of Oncology
Study officials:
affiliation: National Institute of Oncology
name: Miklos Kasler, M.D., Ph.D., D.Sc., Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute of Oncology
name: Laszlo Toth, M.D., Ph.D., Prof.
role: STUDY_CHAIR
affiliation: National Institute of Oncology
name: Ferenc Renyi Vamos, M.D., Ph.D.
role: STUDY_CHAIR
affiliation: National Institute of Oncology
name: Akos Savolt, M.D.
role: STUDY_CHAIR
affiliation: National Institute of Oncology
name: Emil Farkas, M.D.
role: STUDY_CHAIR
affiliation: National Institute of Oncology
name: Ildiko Horti, M.D.
role: STUDY_CHAIR
affiliation: National Institute of Oncology
name: Zoltan Matrai, M.D.
role: PRINCIPAL_INVESTIGATOR
References: