in Situ Breast Cancer, Invasive Breast Cancer
Conditions
Keywords
simple mastectomy, modified radical mastectomy, wound care, suction drain, adaptive suture
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(Arm: Adaptive suture) following simplex mastectomy or modified radical mastectomy in the light of the total volume of withdrawn serum from wound cavity, the extent of early postoperative analgesic requirements and quality of life.
Interventions
PROCEDUREInsertion of suction drain(s) following mastectomy
One suction drain (16 Ch Redon drain) following simple mastectomy and two following modified radical mastectomy.
PROCEDUREAdaptive skin sutures.
Subcutis of skin flaps of the axilla and the wound edges are adapted to the chest wall and pectoralis major muscle by 8 to 24 stitches (depending on the wound surface of the breast and axilla) using 3.0 absorbable sutures, in a distance of 4-5 cm from each other in a chessboard pattern. The wound is then closed with 3.0 running subcutaneous sutures and 4.0 intracutaneous stitches. Compressive dressing is applied on the chest in the first 12-24 hours after surgery.
Sponsors
National Institute of Oncology, Hungary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total amount of sera withdrawn from the wound cavity | 4 weeks | By each follow-up visit within the indicated time frame, the punctuated serum is collected and its volume is measured by a measuring cylinder acquired from the Pharmacy Department and data is recorded. At the end of the follow-up period, the total amount of serum (mL) is documented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of punctions following the removal of suction drain, and total volume of punctuated seroma (mL) | 4 weeks | — |
| Rate of local wound complications. | 4 weeks | — |
| Extent of early postoperative analgesic requirements | 4 days | Assessment of analgesic consumption to achieve adequate pain relief for each patient. Pain relief is carried out according to institutional protocol and includes: diclofenac sodium, diclofenac sodium + orphenadrine, nalbuphine, metamizole sodium, paracetamole, tramadole. |
| Mobility of the shoulder on the side of the operated side | 4 weeks | Assessing shoulder motion on the 1st postoperative day, then weekly for 4 weeks. Abduction 1: 0°- 45° Abduction 2: 45° - 90° Abduction 3: 90° - 135° Abduction 4: 135° - 180° |
| Cost analysis | 4 weeks | Suction drain, suction flask, syringes, number of patient-doctor consultations |
| Assessment of quality of life in the early postoperative period | 4 weeks | Using EORTC QoL BR23, weekly for 4 weeks following surgery. |
Countries
Hungary
Contacts
Primary ContactZoltan Matrai, M.D.
Backup ContactLaszlo Toth, M.D., Ph.D.
Outcome results
None listed