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

Phase 3

• Conditions: Invasive Breast Cancer; in Situ Breast Cancer
• Interventions: Procedure: Adaptive skin sutures.; Procedure: Insertion of suction drain(s) following mastectomy

• Registration Number: NCT01509781
• Lead Sponsor: National Institute of Oncology, Hungary

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(Arm: Adaptive suture) following simplex mastectomy or modified radical mastectomy in the light of the total volume of withdrawn serum from wound cavity, the extent of early postoperative analgesic requirements and quality of life.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-01-08
• Study First Submitted QC: 2012-01-10
• Study First Posted: 2012-01-13
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-05
• Last Update Posted: 2015-10-06
• Primary Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adaptive suture	Adaptive skin sutures.	Following mastectomy, wound cavity is closed with adaptive skin sutures. No suction drain is inserted.
Suction drain	Insertion of suction drain(s) following mastectomy	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.

Primary Outcome Measures

Name	Time	Method
Total amount of sera withdrawn from the wound cavity	4 weeks	By each follow-up visit within the indicated time frame, the punctuated serum is collected and its volume is measured by a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 Outcome Measures

Name	Time	Method
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.
Rate of local wound complications.	4 weeks
Assessment of quality of life in the early postoperative period	4 weeks	Using EORTC QoL BR23, weekly for 4 weeks following surgery.
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°
Number of punctions following the removal of suction drain, and total volume of punctuated seroma (mL)	4 weeks
Cost analysis	4 weeks	Suction drain, suction flask, syringes, number of patient-doctor consultations

Trial Locations

Locations (1)

National Institute of Oncology; 🇭🇺 Budapest, Hungary