Seroma Reduction After Mastectomy

NCT03305757 | Completed Phase 4 DMC

• 1 other identifier: 14-T-21
• Study Type: interventional
• Target: 339
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: Seroma formation and its sequelae form the mainstay of complications in breast cancer surgery. Seroma has an incidence of 3% to 85%. Complications vary from delayed wound healing, infection, skin flap necrosis, patient discomfort and repeated visits to the out patient clinic. The key to reducing seroma formations seems to partly lie in the obliteration of dead space. The use of electrocautery has been demonstrated to increase seroma formation following mastectomy, however no other surgical devices (laser scalpel, argon diathermy and ultrasonic scalpel) or substances have proven to be superior in seroma reduction. No prospective randomized controlled trials have been able to demonstrate which techniques are superior in reducing seroma and as a consequence patient discomfort in patients undergoing mastectomy. In a previous retrospective observational study these investigators demonstrated that mastectomy flap fixation significantly reduced seroma formation and the number of seroma aspirations. In a pilot study that was recently performed in one of the investigators hospitals, ARTISS tissue glue was used for skin flap fixation and showed promising results. The investigators hypothesize that obliteration of the dead space following mastectomy will significantly reduce seroma formation, its complications and the discomfort it causes patients undergoing mastectomy.

Conditions

Seroma; Aspiration; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Number of seroma aspirations

  Number of seroma aspirations performed post mastectomy

  1 year following surgery

Secondary Outcomes (6)

• Number of out patient clinic visits

  1 year following surgery

• Infection rate

  1 year following surgery

• Shoulder function

  1 year following surgery

• Cosmesis

  1 year following surgery

• Impact on Quality of life

  1 year following surgery

Study Arms (3)

conventional wound closure

ACTIVE COMPARATOR

The skin flaps will not undergo further treatment in this group.

Procedure: Conventional

flap fixation with vicryl sutures

EXPERIMENTAL

The skin flaps will be sutured on to the pectoral muscle after having performed the mastectomy.

Procedure: vicryl sutures

Artiss tissue glue

EXPERIMENTAL

ARTISS tissue glue will be applied to the skin flaps after mastectomy

Drug: Artiss

Interventions

Artiss DRUG

Application of ARTISS Glue to skin flaps after mastectomy

Also known as: Artiss glue

Artiss tissue glue

vicryl sutures PROCEDURE

Flap fixation with vicryl sutures after mastectomy

flap fixation with vicryl sutures

Conventional PROCEDURE

Conventional closure after mastectomy

conventional wound closure

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older than 18 years
• Female sex
• Indication for mastectomy or modified radical mastectomy

You may not qualify if:

• Patients undergoing breast conserving therapy
• Patients undergoing direct breast reconstruction
• Unable to comprehend implications and extent of study and sign for informed consent

Sponsors & Collaborators

• Zuyderland Medisch Centrum: lead

Study Sites (1)

Zuyderland Medisch Centrum

Sittard, Limburg, 6162 BG, Netherlands

Location

Related Publications (3)

• van Bastelaar J, Beckers A, Snoeijs M, Beets G, Vissers Y. Flap fixation reduces seroma in patients undergoing mastectomy: a significant implication for clinical practice. World J Surg Oncol. 2016 Mar 8;14:66. doi: 10.1186/s12957-016-0830-8.

  PMID: 26952040 RESULT

• de Rooij L, van Kuijk SMJ, Granzier RWY, Hintzen KFH, Heymans C, Theunissen LLB, von Meyenfeldt EM, van Essen JA, van Haaren ERM, Janssen A, Vissers YLJ, Beets GL, van Bastelaar J. Reducing Seroma Formation and Its Sequelae After Mastectomy by Closure of the Dead Space: A Multi-center, Double-Blind Randomized Controlled Trial (SAM-Trial). Ann Surg Oncol. 2021 May;28(5):2599-2608. doi: 10.1245/s10434-020-09225-8. Epub 2020 Oct 19.

  PMID: 33078318 DERIVED

• van Bastelaar J, Granzier R, van Roozendaal LM, Beets G, Dirksen CD, Vissers Y. A multi-center, double blind randomized controlled trial evaluating flap fixation after mastectomy using sutures or tissue glue versus conventional closure: protocol for the Seroma reduction After Mastectomy (SAM) trial. BMC Cancer. 2018 Aug 17;18(1):830. doi: 10.1186/s12885-018-4740-8.

  PMID: 30119663 DERIVED

MeSH Terms

Conditions

Seroma; Breast Neoplasms

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Officials

• James van Bastelaar, MD

  Zuyderland Medisch Centrum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Randomisation is achieved using a web based randomization programme (RANDI2). Randomization will take place on the day of surgery, after the start of the operation and 30 minutes before wound closure. Blocked randomisation will take place with randomly selected block sizes (6/9/12) with an allocation ratio of 1:1:1. Randomisation will be stratified per site. Both patients and surgeons will be blinded. Patients will be informed preoperatively that their post-operative check ups will NOT be performed by the surgeon that performed the surgery. Randomisation will take place 30 minutes before wound closure in the operating theatre. Post-operatively, patients will not be evaluated by their own surgeon. The OR report will contain the following information (in Dutch) so as to ensure that blinding of the physicians will not be compromised.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Study design is a double-blind randomized controlled trial. All patients are \> 18 years and will be enrolled after obtaining informed consent in the surgical out patient clinics of Zuyderland Medical Center (Heerlen and Sittard), Maastricht University Medical Center, St Jans Gasthuis, Weert and Albert Schweitser Hospital, Dordrecht. All patients have an indication to undergo mastectomy due to invasive breast cancer or DCIS. Follow up will be performed until 1 year after surgery. Patients will be evaluated in the out patient clinic 2 weeks, 6 weeks, 3 months, 6 months and 12 months postoperatively.

Study Record Dates

• First Submitted: January 23, 2017
• First Posted: October 10, 2017
• Study Start: June 1, 2014
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: December 3, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)