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

Invasive Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01509781
• Other study ID #: MRM-987/2011
• Status: Recruiting
• Phase: Phase 3
• First received: January 8, 2012
• Last updated: October 5, 2015
• Start date: September 2011

Study information

• Verified date: October 2015
• Source: National Institute of Oncology, Hungary
• Contact: Zoltan Matrai, M.D.
• Phone: +36 1 224 8600
• Email: matraidoc[@]gmail.hu
• Is FDA regulated: No
• Health authority: Hungary: Pharmaceutical and Healthcare Quality and Organization Development Institute
• Study type: Interventional

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(Arm: Adaptive suture) following simplex mastectomy or modified radical mastectomy in the light of the total volume of withdrawn serum from wound cavity, the extent of early postoperative analgesic requirements and quality of life.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 75 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Breast Neoplasms
• in Situ Breast Cancer
• Invasive Breast Cancer

Intervention

Procedure:
• Insertion of suction drain(s) following mastectomy
One suction drain (16 Ch Redon drain) following simple mastectomy and two following modified radical mastectomy.
• 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.

Locations

Country	Name	City	State
Hungary	National Institute of Oncology	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Oncology, Hungary

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks	No
Secondary	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.	4 days	No
Secondary	Number of punctions following the removal of suction drain, and total volume of punctuated seroma (mL)		4 weeks	No
Secondary	Rate of local wound complications.		4 weeks	No
Secondary	Assessment of quality of life in the early postoperative period	Using EORTC QoL BR23, weekly for 4 weeks following surgery.	4 weeks	No
Secondary	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°	4 weeks	No
Secondary	Cost analysis	Suction drain, suction flask, syringes, number of patient-doctor consultations	4 weeks	No