Investigating the Use of Drains and (Internal) Quilting Sutures on Seroma Formation Following Mastectomy

NCT02668263 | Unknown

• 2 other identifiers: NorthTeesNHSRECRef:14/NE/0091 R&D SUR094
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Seroma formation is a common complication following breast and axillary surgery for breast cancer. The use of drains is commonplace in practice after mastectomy, although there is evidence to suggest that they do not affect the incidence of symptomatic seroma formation. Methods have been adopted in attempts to decrease seroma formation, to varying results, which include the use of deep sutures. The aim of this study is to evaluate the effect of drains and quilting sutures on the incidence of seroma formation. Patients undergoing mastectomy and axillary surgery for breast cancer will be eligible. Patients will be randomized to either receive a drain, no drain or no drain with quilting sutures. The primary outcome measure will be the incidence of symptomatic seroma. Secondary outcome measures will be postoperative length of stay and postoperative pain scores.

Conditions

Breast Cancer

Keywords

Breast cancer; mastectomy; seromas

Outcome Measures

Primary Outcomes (1)

• Seroma formation

  Incidence of symptomatic seroma post-operatively. A seroma defined as a palpable fluid collection under the wound.

  One week post-operatively

Secondary Outcomes (3)

• Seroma aspiration

  up to 1 month

• Pain scores

  up to 2 days post-operatively

• Length of Stay

  up to 1 week

Study Arms (3)

Surgery and Drain

ACTIVE COMPARATOR

Group 1 will be allocated to receive a drain intra-operatively.

Procedure: Surgery and Drain(s)

Surgery alone

OTHER

Group 2 will not receive a drain and no further intervention.

Procedure: Surgery alone

Surgery and quilting sutures

EXPERIMENTAL

Group 3 will not receive a drain but will receive quilting sutures

Procedure: Surgery and Quilting Sutures

Interventions

Surgery alone PROCEDURE

Surgery

Surgery alone

Surgery and Drain(s) PROCEDURE

Drains inserted as per standard practice

Surgery and Drain

Surgery and Quilting Sutures PROCEDURE

Quilting sutures to mastectomy flaps

Surgery and quilting sutures

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females presenting with newly diagnosed carcinoma of the breast with or without axillary node clearance or sampling.
• They must be at least 18 years of age and have capacity to give informed consent.

You may not qualify if:

• Male
• Those who do not have capacity
• Previous breast cancer in the same breast and previous axillary surgery
• Previous chest wall radiotherapy
• Patients with metastatic cancer including lymphoma, pre-existing lymphoedema
• Intercurrent infection or hypoalbuminaemia (\<36 g/L)
• Patients part of other research trials.

Sponsors & Collaborators

• North Tees and Hartlepool NHS Foundation Trust: lead
• Newcastle-upon-Tyne Hospitals NHS Trust: collaborator
• Gateshead Health NHS Foundation Trust: collaborator
• Northumbria Healthcare NHS Foundation Trust: collaborator

Study Sites (1)

Department of Surgery, North Tees and Hartlepool NHS Foundation Trust

Stockton-on-Tees, Cleveland, TS19 8PE, United Kingdom

RECRUITING

Related Publications (12)

• Agrawal A, Ayantunde AA, Cheung KL. Concepts of seroma formation and prevention in breast cancer surgery. ANZ J Surg. 2006 Dec;76(12):1088-95. doi: 10.1111/j.1445-2197.2006.03949.x.

  PMID: 17199696 BACKGROUND

• Woodworth PA, McBoyle MF, Helmer SD, Beamer RL. Seroma formation after breast cancer surgery: incidence and predicting factors. Am Surg. 2000 May;66(5):444-50; discussion 450-1.

  PMID: 10824744 BACKGROUND

• Hashemi E, Kaviani A, Najafi M, Ebrahimi M, Hooshmand H, Montazeri A. Seroma formation after surgery for breast cancer. World J Surg Oncol. 2004 Dec 9;2:44. doi: 10.1186/1477-7819-2-44.

  PMID: 15588301 BACKGROUND

• Sampathraju S, Rodrigues G. Seroma formation after mastectomy: pathogenesis and prevention. Indian J Surg Oncol. 2010 Dec;1(4):328-33. doi: 10.1007/s13193-011-0067-5. Epub 2011 Apr 2.

  PMID: 22693384 BACKGROUND

• Akinci M, Cetin B, Aslan S, Kulacoglu H. Factors affecting seroma formation after mastectomy with full axillary dissection. Acta Chir Belg. 2009 Jul-Aug;109(4):481-3. doi: 10.1080/00015458.2009.11680464.

  PMID: 19803259 BACKGROUND

• Jain PK, Sowdi R, Anderson AD, MacFie J. Randomized clinical trial investigating the use of drains and fibrin sealant following surgery for breast cancer. Br J Surg. 2004 Jan;91(1):54-60. doi: 10.1002/bjs.4435.

  PMID: 14716794 BACKGROUND

• Barwell J, Campbell L, Watkins RM, Teasdale C. How long should suction drains stay in after breast surgery with axillary dissection? Ann R Coll Surg Engl. 1997 Nov;79(6):435-7.

  PMID: 9422871 BACKGROUND

• Kopelman D, Klemm O, Bahous H, Klein R, Krausz M, Hashmonai M. Postoperative suction drainage of the axilla: for how long? Prospective randomised trial. Eur J Surg. 1999 Feb;165(2):117-20; discussion 121-2. doi: 10.1080/110241599750007289.

  PMID: 10192568 BACKGROUND

• Bailey SH, Oni G, Guevara R, Wong C, Saint-Cyr M. Latissimus dorsi donor-site morbidity: the combination of quilting and fibrin sealant reduce length of drain placement and seroma rate. Ann Plast Surg. 2012 Jun;68(6):555-8. doi: 10.1097/SAP.0b013e318216b65c.

  PMID: 21629082 BACKGROUND

• Dancey AL, Cheema M, Thomas SS. A prospective randomized trial of the efficacy of marginal quilting sutures and fibrin sealant in reducing the incidence of seromas in the extended latissimus dorsi donor site. Plast Reconstr Surg. 2010 May;125(5):1309-1317. doi: 10.1097/PRS.0b013e3181d4fb68.

  PMID: 20440152 BACKGROUND

• Sakkary MA. The value of mastectomy flap fixation in reducing fluid drainage and seroma formation in breast cancer patients. World J Surg Oncol. 2012 Jan 11;10:8. doi: 10.1186/1477-7819-10-8.

  PMID: 22236813 BACKGROUND

• Schuijtvlot M, Sahu AK, Cawthorn SJ. A prospective audit of the use of a buttress suture to reduce seroma formation following axillary node dissection without drains. Breast. 2002 Feb;11(1):94-6. doi: 10.1054/brst.2001.0366.

  PMID: 14965653 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Seroma

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

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

Study Officials

• Pud Bhaskar, MBBS, MD

  North Tees & Hartepool NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pud Bhaskar, MBBS, MD

CONTACT

01642 624710; pud.bhaskar@nth.nhs.uk

Liz Baker, PhD

CONTACT

01642 624163; Liz.Baker@nth.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant General and Breast Oncoplastic Surgeon

Study Record Dates

• First Submitted: January 18, 2016
• First Posted: January 29, 2016
• Study Start: November 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: January 29, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)