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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2015 by Dr. Zoltan Matrai, National Institute of Oncology, Hungary.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01509781
First Posted: January 13, 2012
Last Update Posted: October 6, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Zoltan Matrai, National Institute of Oncology, Hungary
  Purpose
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(Arm: Adaptive suture) following simplex mastectomy or modified radical mastectomy in the light of the total volume of withdrawn serum from wound cavity, the extent of early postoperative analgesic requirements and quality of life.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 Intervention Phase
in Situ Breast Cancer Invasive Breast Cancer Procedure: Insertion of suction drain(s) following mastectomy Procedure: Adaptive skin sutures. Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Dr. Zoltan Matrai, National Institute of Oncology, Hungary:

Primary Outcome Measures:
  • Total amount of sera withdrawn from the wound cavity [ Time Frame: 4 weeks ]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.


Secondary Outcome Measures:
  • 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.

  • Number of punctions following the removal of suction drain, and total volume of punctuated seroma (mL) [ Time Frame: 4 weeks ]
  • Rate of local wound complications. [ Time Frame: 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.

  • 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°


  • Cost analysis [ Time Frame: 4 weeks ]
    Suction drain, suction flask, syringes, number of patient-doctor consultations


Estimated Enrollment: 400
Study Start Date: September 2011
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01509781


Contacts
Contact: Zoltan Matrai, M.D. +36 1 224 8600 ext 3302 matraidoc@gmail.hu
Contact: Laszlo Toth, M.D., Ph.D. toth.l@oncol.hu

Locations
Hungary
National Institute of Oncology Recruiting
Budapest, Hungary, 1122
Contact: Zoltan Matrai, M.D.    +3612248600 ext 3302    matraidoc@gmail.com   
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
  More Information

Responsible Party: Dr. Zoltan Matrai, principal investigator, National Institute of Oncology, Hungary
ClinicalTrials.gov Identifier: NCT01509781     History of Changes
Other Study ID Numbers: MRM-987/2011
First Submitted: January 8, 2012
First Posted: January 13, 2012
Last Update Posted: October 6, 2015
Last Verified: October 2015

Keywords provided by Dr. Zoltan Matrai, National Institute of Oncology, Hungary:
simple mastectomy
modified radical mastectomy
wound care
suction drain
adaptive suture

Additional relevant MeSH terms:
Breast Neoplasms
Breast Carcinoma In Situ
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type