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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Brief Summary

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(Arm: Adaptive suture) following simplex mastectomy or modified radical mastectomy in the light of the total volume of withdrawn serum from wound cavity, the extent of early postoperative analgesic requirements and quality of life.

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Detailed Description

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Conditions

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in Situ Breast Cancer Invasive Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Insertion of suction drain(s) following mastectomy

Intervention Type PROCEDURE

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

Adaptive suture

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

Group Type EXPERIMENTAL

Adaptive skin sutures.

Intervention Type PROCEDURE

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.

Interventions

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Insertion of suction drain(s) following mastectomy

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

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Dr. Zoltan Matrai

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR