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

October 5, 2015 updated by: Dr. Zoltan Matrai, National Institute of Oncology, Hungary

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

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(Arm: Adaptive suture) following simplex mastectomy or modified radical mastectomy in the light of the total volume of withdrawn serum from wound cavity, the extent of early postoperative analgesic requirements and quality of life.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary, 1122
        • Recruiting
        • National Institute of Oncology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total amount of sera withdrawn from the wound cavity
Time Frame: 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.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extent of early postoperative analgesic requirements
Time Frame: 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.
4 days
Number of punctions following the removal of suction drain, and total volume of punctuated seroma (mL)
Time Frame: 4 weeks
4 weeks
Rate of local wound complications.
Time Frame: 4 weeks
4 weeks
Assessment of quality of life in the early postoperative period
Time Frame: 4 weeks
Using EORTC QoL BR23, weekly for 4 weeks following surgery.
4 weeks
Mobility of the shoulder on the side of the operated side
Time Frame: 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°
4 weeks
Cost analysis
Time Frame: 4 weeks
Suction drain, suction flask, syringes, number of patient-doctor consultations
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

January 8, 2012

First Submitted That Met QC Criteria

January 10, 2012

First Posted (Estimate)

January 13, 2012

Study Record Updates

Last Update Posted (Estimate)

October 6, 2015

Last Update Submitted That Met QC Criteria

October 5, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRM-987/2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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