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

Sponsor

National Institute of Oncology, Hungary (Other)

Overall Status

Unknown status

CT.gov ID

NCT01509781

Collaborator

(none)

400

Enrollment

Location

Arms

Study Details

Study Description

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(Arm: Adaptive suture) following simplex mastectomy or modified radical mastectomy in the light of the total volume of withdrawn serum from wound cavity, the extent of early postoperative analgesic requirements and quality of life.

Condition or Disease	Intervention/Treatment	Phase
in Situ Breast Cancer Invasive Breast Cancer	Procedure: Insertion of suction drain(s) following mastectomy Procedure: Adaptive skin sutures.	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

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

Study Start Date :

Sep 1, 2011

Anticipated Primary Completion Date :

Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Procedure: 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.	Procedure: 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.

Arm

Intervention/Treatment

Active Comparator: 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.

Procedure: 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.

Procedure: 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.

Outcome Measures

Primary Outcome Measures

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

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.
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]
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°
Cost analysis [4 weeks]
Suction drain, suction flask, syringes, number of patient-doctor consultations

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 75 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Institute of Oncology	Budapest		Hungary	1122

Sponsors and Collaborators

National Institute of Oncology, Hungary

Investigators

Principal Investigator: Miklos Kasler, M.D., Ph.D., D.Sc., Prof., National Institute of Oncology
Study Chair: Laszlo Toth, M.D., Ph.D., Prof., National Institute of Oncology
Study Chair: Ferenc Renyi Vamos, M.D., Ph.D., National Institute of Oncology
Study Chair: Akos Savolt, M.D., National Institute of Oncology
Study Chair: Emil Farkas, M.D., National Institute of Oncology
Study Chair: Ildiko Horti, M.D., National Institute of Oncology
Principal Investigator: Zoltan Matrai, M.D., National Institute of Oncology