NCT01509781

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(Arm: Adaptive suture) following simplex mastectomy or modified radical mastectomy in the light of the total volume of withdrawn serum from wound cavity, the extent of early postoperative analgesic requirements and quality of life.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 13, 2012

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Last Updated

October 6, 2015

Status Verified

October 1, 2015

Enrollment Period

4.3 years

First QC Date

January 8, 2012

Last Update Submit

October 5, 2015

Conditions

in Situ Breast CancerInvasive Breast Cancer

Keywords

simple mastectomymodified radical mastectomywound caresuction drainadaptive suture

Outcome Measures

Primary Outcomes (1)

  • Total amount of sera withdrawn from the wound cavity

    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 Outcomes (6)

  • Extent of early postoperative analgesic requirements

    4 days

  • Number of punctions following the removal of suction drain, and total volume of punctuated seroma (mL)

    4 weeks

  • Rate of local wound complications.

    4 weeks

  • Assessment of quality of life in the early postoperative period

    4 weeks

  • Mobility of the shoulder on the side of the operated side

    4 weeks

  • +1 more secondary outcomes

Study Arms (2)

Suction drain

ACTIVE COMPARATOR

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

Adaptive suture

EXPERIMENTAL

Following mastectomy, wound cavity is closed with adaptive skin sutures. No suction drain is inserted.

Procedure: Adaptive skin sutures.

Interventions

Insertion of suction drain(s) following mastectomyPROCEDURE

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

Suction drain
Adaptive skin sutures.PROCEDURE

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.

Adaptive suture

Eligibility Criteria

AgeUp to 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • female patients with primary unilateral, stage 0, I or II, T3N1M0 breast cancer necessitating simple or modified radical mastectomy

You may not qualify if:

  • age above 75 years and bad general state
  • pregnancy
  • autoimmune disease
  • non-radical excision
  • mastitis carcinomatosis
  • lymphangitis carcinomatosis
  • wound infection necessitating treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Oncology

Budapest, Budapest, 1122, Hungary

RECRUITING

MeSH Terms

Conditions

Breast Carcinoma In Situ

Condition Hierarchy (Ancestors)

Carcinoma in SituCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsBreast NeoplasmsNeoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

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

    National Institute of Oncology

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY CHAIR

  • Zoltan Matrai, M.D.

    National Institute of Oncology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zoltan Matrai, M.D.

CONTACT

+36 1 224 8600matraidoc@gmail.hu

Laszlo Toth, M.D., Ph.D.

CONTACT

toth.l@oncol.hu

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

January 8, 2012

First Posted

January 13, 2012

Study Start

September 1, 2011

Primary Completion

January 1, 2016

Last Updated

October 6, 2015

Record last verified: 2015-10

Locations

HU(1)