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

National Institute of Oncology, Hungary

Status and phase: Unknown; Phase 3

Conditions: in Situ Breast Cancer; Invasive Breast Cancer

Treatments: Procedure: Insertion of suction drain(s) following mastectomy; Procedure: Adaptive skin sutures.

Study type: Interventional

Funder types: Other

Identifiers

NCT01509781

MRM-987/2011

Details and patient eligibility

About

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(Arm: Adaptive suture) following simplex mastectomy or modified radical mastectomy in the light of the total volume of withdrawn serum from wound cavity, the extent of early postoperative analgesic requirements and quality of life.

Enrollment: 400 estimated patients

Sex: Female

Ages: Under 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Suction drain

Active Comparator group

Description:

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.

Treatment:

Procedure: Insertion of suction drain(s) following mastectomy

Adaptive suture

Experimental group

Description:

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

Treatment:

Procedure: Adaptive skin sutures.