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 because the information has not been verified recently.
Verified February 2012 by National Institute of Oncology, Hungary.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Dr. Zoltan Matrai, National Institute of Oncology, Hungary
ClinicalTrials.gov Identifier:
NCT01509781
First received: January 8, 2012
Last updated: February 8, 2012
Last verified: February 2012
  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(Arm: Adaptive suture) following simplex mastectomy or modified radical mastectomy in the light of the total volume of withdrawn serum from wound cavity, the extent of early postoperative analgesic requirements and quality of life.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: 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 National Institute of Oncology, Hungary:

Primary Outcome Measures:
  • Total amount of sera withdrawn from the wound cavity [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Rate of local wound complications. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Assessment of quality of life in the early postoperative period [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    Suction drain, suction flask, syringes, number of patient-doctor consultations


Estimated Enrollment: 400
Study Start Date: September 2011
Estimated Primary Completion Date: October 2012 (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

Ages Eligible for Study:   up to 75 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 8, 2012
Last Updated: February 8, 2012
Health Authority: Hungary: Pharmaceutical and Healthcare Quality and Organization Development Institute

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

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

ClinicalTrials.gov processed this record on July 23, 2014