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

NCT01509781 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2015-10-06

No results posted yet for this study

Summary

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(Arm: Adaptive suture) following simplex mastectomy or modified radical mastectomy in the light of the total volume of withdrawn serum from wound cavity, the extent of early postoperative analgesic requirements and quality of life.

Conditions

Interventions

PROCEDURE

Insertion of suction drain(s) following mastectomy

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

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.

Sponsors & Collaborators

  • National Institute of Oncology, Hungary

    lead OTHER

Principal Investigators

  • Miklos Kasler, M.D., Ph.D., D.Sc., Prof. · National Institute of Oncology

  • Laszlo Toth, M.D., Ph.D., Prof. · National Institute of Oncology

  • Ferenc Renyi Vamos, M.D., Ph.D. · National Institute of Oncology

  • Akos Savolt, M.D. · National Institute of Oncology

  • Emil Farkas, M.D. · National Institute of Oncology

  • Ildiko Horti, M.D. · National Institute of Oncology

  • Zoltan Matrai, M.D. · National Institute of Oncology

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2016-01-31

Countries

  • Hungary

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01509781 on ClinicalTrials.gov