Suction Drain Versus the Use of Adaptive Skin Sutures After Mastectomy ± Axillary Lymphadenectomy; a Prospective Randomised Study

Comparador Ativo: Suction drain

Patients in Arm A undergo simplex mastectomy or modified radical mastectomy. One plastic Redon drain (16 Ch) is placed after simplex mastectomy and two plastic Redon drains (16 Ch each) following modified radical mastectomy.

Procedimento: Insertion of suction drain(s) following mastectomy

One suction drain (16 Ch Redon drain) following simple mastectomy and two following modified radical mastectomy.

Experimental: Adaptive suture

Following mastectomy, wound cavity is closed with adaptive skin sutures. No suction drain is inserted.

Procedimento: Adaptive 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.

Total amount of sera withdrawn from the wound cavity

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.

Extent of early postoperative analgesic requirements

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.

Number of punctions following the removal of suction drain, and total volume of punctuated seroma (mL)

Rate of local wound complications.

Assessment of quality of life in the early postoperative period

Using EORTC QoL BR23, weekly for 4 weeks following surgery.

Mobility of the shoulder on the side of the operated side

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

Suction drain, suction flask, syringes, number of patient-doctor consultations