Clinical trial · Interventional
Investigating the Use of Drains and (Internal) Quilting Sutures on Seroma Formation Following Mastectomy
Randomised Clinical Trial Investigating the Use of Drains and Quilting Sutures on Seroma Formation Following Mastectomy - A Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Surgery alone | Procedure | — | UNRESOLVED |
| Surgery and Drain(s) | Procedure | — | UNRESOLVED |
| Surgery and Quilting Sutures | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Surgery and Drain
- description
- Group 1 will be allocated to receive a drain intra-operatively.
- interventionNames
- Procedure: Surgery and Drain(s)
- type
- OTHER
- label
- Surgery alone
- description
- Group 2 will not receive a drain and no further intervention.
- interventionNames
- Procedure: Surgery alone
- type
- EXPERIMENTAL
- label
- Surgery and quilting sutures
- description
- Group 3 will not receive a drain but will receive quilting sutures
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (12)
- BACKGROUNDAgrawal 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
- BACKGROUNDWoodworth 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
- BACKGROUNDHashemi 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
- BACKGROUNDSampathraju 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
- BACKGROUNDAkinci 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
- BACKGROUNDJain 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
- BACKGROUNDBarwell 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
- BACKGROUNDKopelman 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.