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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


Phase 3
N/A
75 Years
Open (Enrolling)
Female
in Situ Breast Cancer, Invasive Breast Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Outcome Measure:

Total amount of sera withdrawn from the wound cavity

Outcome Description:

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.

Outcome Time Frame:

4 weeks

Safety Issue:

No

Principal Investigator

Miklos Kasler, M.D., Ph.D., D.Sc., Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Institute of Oncology

Authority:

Hungary: Pharmaceutical and Healthcare Quality and Organization Development Institute

Study ID:

MRM-987/2011

NCT ID:

NCT01509781

Start Date:

September 2011

Completion Date:

Related Keywords:

  • in Situ Breast Cancer
  • Invasive Breast Cancer
  • simple mastectomy
  • modified radical mastectomy
  • wound care
  • suction drain
  • adaptive suture
  • Breast Neoplasms
  • Carcinoma in Situ

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