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

Primary Purpose

in Situ Breast Cancer, Invasive Breast Cancer

Status

Unknown status

Phase

Phase 3

Locations

Hungary

Study Type

Interventional

Intervention

Insertion of suction drain(s) following mastectomy

Adaptive skin sutures.

About this trial

This is an interventional health services research trial for in Situ Breast Cancer focused on measuring simple mastectomy, modified radical mastectomy, wound care, suction drain, adaptive suture

Eligibility Criteria

undefined - 75 Years (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

National Institute of OncologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Suction drain

Adaptive suture

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Total amount of sera withdrawn from the wound cavity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.

Secondary Outcome Measures

Extent of early postoperative analgesic requirements

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)

Rate of local wound complications.

Assessment of quality of life in the early postoperative period

Using EORTC QoL BR23, weekly for 4 weeks following surgery.

Mobility of the shoulder on the side of the operated side

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

Suction drain, suction flask, syringes, number of patient-doctor consultations

Full Information

NCT ID

NCT01509781

First Posted

January 8, 2012

Last Updated

October 5, 2015

Sponsor

National Institute of Oncology, Hungary

1. Study Identification

Unique Protocol Identification Number

NCT01509781

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Unknown status

Study Start Date

September 2011 (undefined)

Primary Completion Date

January 2016 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Institute of Oncology, Hungary

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

in Situ Breast Cancer, Invasive Breast Cancer

Keywords

simple mastectomy, modified radical mastectomy, wound care, suction drain, adaptive suture

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Suction drain

Arm Type

Active Comparator

Arm Description

Arm Title

Adaptive suture

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Insertion of suction drain(s) following mastectomy

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Adaptive skin sutures.

Intervention Description

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.

Primary Outcome Measure Information:

Title

Total amount of sera withdrawn from the wound cavity

Description

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Extent of early postoperative analgesic requirements

Description

Time Frame

4 days

Title

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

Time Frame

4 weeks

Title

Rate of local wound complications.

Time Frame

4 weeks

Title

Assessment of quality of life in the early postoperative period

Description

Using EORTC QoL BR23, weekly for 4 weeks following surgery.

Time Frame

4 weeks

Title

Mobility of the shoulder on the side of the operated side

Description

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°

Time Frame

4 weeks

Title

Cost analysis

Description

Suction drain, suction flask, syringes, number of patient-doctor consultations

Time Frame

4 weeks

10. Eligibility

Sex

Female

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zoltan Matrai, M.D.

Phone

+36 1 224 8600

Ext

3302

matraidoc@gmail.hu

First Name & Middle Initial & Last Name or Official Title & Degree

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

toth.l@oncol.hu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation