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Wound drainage after axillary dissection for carcinoma of the breast

  1. David R Thomson1,*,
  2. Hazim Sadideen2,
  3. Dominic Furniss3

Editorial Group: Cochrane Breast Cancer Group

Published Online: 20 OCT 2013

Assessed as up-to-date: 22 FEB 2013

DOI: 10.1002/14651858.CD006823.pub2


How to Cite

Thomson DR, Sadideen H, Furniss D. Wound drainage after axillary dissection for carcinoma of the breast. Cochrane Database of Systematic Reviews 2013, Issue 10. Art. No.: CD006823. DOI: 10.1002/14651858.CD006823.pub2.

Author Information

  1. 1

    University of Oxford, John Radcliffe Hospital, Oxford University Clinical Academic Graduate School, Oxford, Oxfordshire, UK

  2. 2

    University Hospitals Birmingham NHS Foundation Trust, Department of Plastic, Reconstructive and Burns Surgery, Birmingham, West Midlands, UK

  3. 3

    Oxford University Hospitals NHS Trust, Department of Plastic and Reconstructive Surgery, Oxford, Oxfordshire, UK

*David R Thomson, Oxford University Clinical Academic Graduate School, University of Oxford, John Radcliffe Hospital, Medical Sciences Division, Level 3, John Radcliffe Hospital., Oxford, Oxfordshire, OX3 9DU, UK. davidthomson134@gmail.com.

Publication History

  1. Publication Status: New
  2. Published Online: 20 OCT 2013

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Characteristics of included studies [ordered by year of study]
Cameron 1988

MethodsSingle-centre prospective randomised trial of 40 consecutive participants


Participantsn = 40. Drain 20, no drain 20. Age of participants, years: drain 50 ± 2.6, no drain 52 ± 2.7


InterventionsDrain versus no drain. Single closed suction Redivac drain


OutcomesSeroma, duration of hospital stay, infection


NotesSetting: Department of Surgery, King’s College Hospital, UK

Funding source not stated


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risk“Sequentially numbered sealed envelope”—doesn't say 'opaque', not clear if this was a random sequence

Allocation concealment (selection bias)Low riskAllocation revealed only after haemostasis had been achieved with diathermy. After allocation, no further use of diathermy allowed

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskCannot blind surgeons or participants to presence/absence of drain. Unclear what effect, if any, this would have

Blinding of outcome assessment (detection bias)
All outcomes
High riskDo not define seroma or infection

Authors state, “after discharge from hospital, follow-up and treatment were not uniform: therefore data have not been collected concerning the subsequent incidence of late complications”

Incomplete outcome data (attrition bias)
All outcomes
High riskOutcomes reported on all 40 participants. No dropouts whilst in hospital. No data on follow-up period because “follow-up and treatment were not uniform”

Selective reporting (reporting bias)High riskReport on all participants on hospital stay, seroma and infection. No data on follow-up period because “follow-up and treatment were not uniform”

Other biasUnclear riskNo other biases

Somers 1992

MethodsSingle-centre prospective randomised controlled trial on 227 participants undergoing breast-conserving therapy with level I and level II axillary dissection


Participantsn = 227. Drain 108, no drain 119. Age of participants, years: drain 60.1 ± 12.8, no drain 59.3 ± 13.8 (mean ± SD)


InterventionsDrain versus no drain. Jackson-Pratt closed suction


OutcomesSeroma, total volume of drainage, total number of aspirations, number of days from surgery to final aspiration, wound infection, lymphoedema, impaired shoulder movement, haematoma, wound dehiscence


NotesSetting: Albert Einstein Medical Centre, Philadelphia, Pennsyvania, USA

Funding source not stated


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskRandomisation method based on the last digit of the participant's admission number—pseudorandomisation. Code could easily be broken by surgeon performing several operations

Allocation concealment (selection bias)High riskMethod only pseudorandomisation, so easy to crack code

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskCannot blind surgeons or participants to presence/absence of drain. Unclear what effect, if any, this would have

Blinding of outcome assessment (detection bias)
All outcomes
Low riskSeroma defined: "any palpable or ballottable fluid collection"

Aspiration defined: "all collections were aspirated...regardless of size or symptoms"

Wound infection defined: "erythema, warmth or purulent drainage at incision site"

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskClearly state why four patients were excluded from drain group because drains were left in for > 1 day, in breach of study protocol. 4/109—affects 3% of study population, but unclear why they went > 1 day—all could have developed infection, lots of aspirations required

Selective reporting (reporting bias)Low riskNo unreported outcomes

Other biasLow riskNo other biases in study design. Good write-up with lots of detail and good objective definitions of study outcomes

Zavotksy 1998

MethodsProspective randomised control trial on 46 participants undergoing breast-conserving surgery


Participantsn = 46. Drain 24, no drain 22. Age of participants, years: drain 58.2, no drain 59.6 (median age). All participants undergoing treatment for stage I or stage II breast cancer


InterventionsDrain versus no drain. Jackson-Pratt closed suction


OutcomesNumber of lymph nodes removed, number of tumour-positive lymph nodes, primary tumour size, postop seroma aspiration, mean aspirate volume, mean duration of drainage in drain group, postoperative drain insertion, infection, haematoma, lymphoedema, arm circumference, number of office visits, pain score on a 0 to 10 scale


NotesSetting: John Wayne Cancer Institute, a tertiary cancer centre, USA

Funding source: Ben B. and Joyce E. Eisenberg Foundation (Los Angeles) and the Fashion Footwear Association

This paper studied 115 participants, of whom 46 were studied prospectively and 69 retrospectively. This meta-analysis includes only the 46 randomly assigned, prospective participants


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risk“At the completion of the dissection, patients in the prospective group were intra-operatively randomised to drain or no-drain groups”. No discussion of method of randomisation

Allocation concealment (selection bias)Low riskAllocation revealed at end of operation

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskCannot blind surgeons or participants to presence/absence of drain. Unclear what effect, if any, this would have

Blinding of outcome assessment (detection bias)
All outcomes
High riskParticipants followed up as required, no discussion of randomisation for 4 follow-up visits for measurement of pain and arm circumference

No definitions of seroma, criteria for aspiration or infection

Theoretical bias risk that assessment of postoperative seroma and decisions to aspirate could be biased for different groups

Incomplete outcome data (attrition bias)
All outcomes
Low risk2/24 participants in drain group did not have duration of drainage recorded, no reason given

No other study dropouts

Selective reporting (reporting bias)Low riskAll outcomes reported

Other biasLow riskNo other biases

Purushotham 2002

MethodsTwo parallel randomised trial arms looking at wide local excision (breast-conserving surgery) and mastectomy participants separately


Participantsn = 375. Mastectomy arm: drain 96, no drain 94. BCT arm: drain 94, no drain 91. Age of participants, years: mastectomy arm: drain 58.1 ± 12.1, no drain 58.4 ± 12.2. BCT arm: drain 57.1 ± 9.1, no drain: 56.9 ± 10.2 (mean ± SD). All participants undergoing treatment for primary breast cancer


InterventionsDrain versus no drain. Portovac drains. Single axillary drain for both arms, plus a second drain under mastectomy flaps, no second drain for BCT participants


OutcomesPrimary outcome: length of hospital stay

Secondary outcomes: surgical morbidity—seroma, volume and number of aspirations, infection, shoulder movement


NotesSetting not clearly stated, presumed Western Infirmary, UK

Funding source: grant from Chief Scientist Office of the Department of Health, Scottish Executive


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risk"Consecutively numbered opaque envelopes"—not stated what was put into the envelopes

Allocation concealment (selection bias)Unclear riskAuthors do not state when allocation was revealed

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskCannot blind surgeons or participants to presence/absence of drain. Unclear what effect, if any, this would have

Blinding of outcome assessment (detection bias)
All outcomes
High riskParticipants discharged after drain removal, so follow-up could be blind to treatment, although surgeons may recognise participants from wards/theatre

Infection defined: ASEPSIS score for infection > 10

No description of seroma definition or aspiration threshold—HIGH bias

Incomplete outcome data (attrition bias)
All outcomes
Low riskClear CONSORT diagram, no dropouts

Selective reporting (reporting bias)High riskNumber of aspirations not reported

Other biasHigh riskStudy design

However, trial primarily looking at hospital stay length. Drain groups released when < 50 mL/24 h or 5 days, whenever soonest. No drains released 24 to 48 hours later, inherent bias in this design towards keeping drain participants for longer time based on protocol

Trial excluded women not thought suitable for early discharge—surely these women would make no drain + early discharge more psychologically damaging and potentially alter trial conclusions—cannot generalise from this trial to ALL women undergoing breast surgery

Jain 2004

MethodsSingle-centre randomised controlled trial on 116 participants undergoing breast-conserving surgery or mastectomy with level I/II axillary dissection. No drain group stratified into 29 treated with Tisseel fibrin sealant and 29 without. Only 29 participants treated without Tisseel included in no drain meta-analysis group


Participantsn = 87. Drain 58, no drain 29. Mastectomy: drain 9, no drain 10. BCT arm: drain 22, no drain 17. Age of participants, years: drain: 61.9 ± 13.2, no drain: 62.3 ± 12.3 (mean ± SD)


InterventionsDrain versus no drain. Single 14-Fr vacuum drain


OutcomesPrimary outcome: incidence of symptomatic seroma

Secondary outcomes: hospital stay, pain scores, total volume of aspirate, number of aspirations, infection


NotesSetting: Department of Surgery, Scarborough General Hospital, UK

Funding source: not stated


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskSealed, opaque envelope containing computer-generated random numbers

Allocation concealment (selection bias)Low riskEnvelope opened by theatre nursing staff at the end of the operation to reveal allocation

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskCannot blind surgeons or participants to presence/absence of drain. Unclear what effect, if any, this would have

Blinding of outcome assessment (detection bias)
All outcomes
Low riskSeroma defined as "palpable fluid collection under the wound"

Wound infection defined as "erythema, tenderness and/or purulent discharge from the incision site"

Only clinically symptomatic seromas aspirated

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo participant dropouts

Selective reporting (reporting bias)Low riskAll outcomes reported

Other biasLow riskNo other biases

Soon 2005

MethodsSingle-centre prospective randomised controlled trial on 87 participants undergoing breast cancer surgery with level III axillary dissection


Participantsn = 87. Drain 36, no drain 51. Age of participants, years: drain 59, no drain 58 (no SD reported)

Previous axillary lymph node surgery (except SLNB) and prior axillary or chest wall irradiation are exclusion criteria


InterventionsDrain for 24 to 48 hours postoperatively versus no drain. Closed suction drain


OutcomesMean number of lymph nodes involved and total number of lymph nodes excised (check other studies for these data to look for a trend), seroma, total seroma volume, number of aspirations, length of seroma persistence, inpatient stay length, infection—cellulitis oral antibiotics, cellulitis IV antibiotics, abscess requiring drainage, haematoma, lymphoedema, skin necrosis


NotesSetting: Breast/Endocrine Unit, St. George’s Hospital, UK

Funding source: not stated


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskPseudorandomisation based on day of the month. If operation happened on odd day—drain inserted, even day—no drain

Allocation concealment (selection bias)High riskPseudorandomisation method used very easily known by surgeons. Cannot conceal allocation, as surgeon will know from the start whether participant is to receive a drain

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskCannot blind surgeons or participants to presence/absence of drain. Unclear what effect, if any, this would have

Blinding of outcome assessment (detection bias)
All outcomes
High riskSeroma and infection not defined

Any seroma was aspirated, so limited scope for subjective interpretation

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo explicit description of dropouts, but apparent from data that full outcome assessment was performed on all participants

Selective reporting (reporting bias)Low riskAll outcomes reported

Other biasLow riskNo other biases

Classe 2006

MethodsSingle-centre randomised controlled trial on participants undergoing breast-conserving surgery with level I/II axillary dissection


Participantsn = 98. Drain 51, no drain 47. Age of participants, years: drain 60 ± 10, no drain 58 ± 11 (mean ± SD)


InterventionsDrain till flow < 35 mL/24 hours versus no drain with axillary padding. Type of drain not stated


OutcomesPrimary outcome: reduction in length of hospital stay

Secondary outcomes: seroma, aspiration, volume of aspiration, total drainage, time from surgery to final drainage, infection, shoulder movement, pain, quality of life


NotesSetting: Nantes Saint Herblain, France

Funding source: not stated


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskDoes not state method used. Say that “randomisation was done in blocks of six”

Allocation concealment (selection bias)Unclear riskDoes not state when random assignment was revealed

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskCannot blind surgeons or participants to presence/absence of a drain. Unclear what effect, if any, this would have

Blinding of outcome assessment (detection bias)
All outcomes
Low riskBoth groups followed-up for 1 month using the same schedule of postop visits

Seroma defined as "palpable fluid accumulation causing discomfort and needing aspiration"

Wound infection defined as "inflamed wound with pyrexia and positive microbiology that needed antibiotic treatment"

Incomplete outcome data (attrition bias)
All outcomes
Low riskNo dropouts noted, full follow-up of all participants

Selective reporting (reporting bias)Low riskAll outcome measures reported

Other biasHigh riskNot a fair comparison—external compression versus drain with no attempt to close dead space

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Garbay 2012Not an RCT, data obtained from two successive prospective studies

Talbot 2002Not an RCT, participants treated in consecutive series, no randomisation

Warren 1994Study of breast biopsy wounds, not axillary dissection

Wheeler 1976Study of breast biopsy wounds, not axillary dissection

 
Comparison 1. Seroma

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Seroma7960Odds Ratio (M-H, Random, 95% CI)0.46 [0.23, 0.91]

 2 Seroma—breast-conserving therapy5595Odds Ratio (M-H, Random, 95% CI)0.64 [0.23, 1.76]

 3 Seroma—mastectomy2238Odds Ratio (M-H, Random, 95% CI)0.26 [0.02, 2.82]

 4 Seroma—Somers and Soon excluded5646Odds Ratio (M-H, Random, 95% CI)0.44 [0.18, 1.11]

 
Comparison 2. Infection

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Infection7960Odds Ratio (M-H, Fixed, 95% CI)0.70 [0.44, 1.12]

 
Comparison 3. Lymphoedema

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Lymphoedema3360Odds Ratio (M-H, Fixed, 95% CI)2.31 [0.47, 11.37]

 
Comparison 4. Length of hospital stay

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Length of hospital stay4600Mean Difference (IV, Random, 95% CI)1.47 [0.67, 2.28]

 2 Length of hospital stay (Cameron and Classe)2138Mean Difference (IV, Random, 95% CI)1.62 [-0.54, 3.77]

 
Comparison 5. Postoperative seroma aspirations

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Number of postoperative seroma aspirations2212Mean Difference (IV, Fixed, 95% CI)-0.79 [-1.23, -0.35]

 2 Volume of postoperative seroma aspirations3519Mean Difference (IV, Fixed, 95% CI)-19.44 [-59.45, 20.57]

 
Comparison 6. Haematoma

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Haematoma2314Odds Ratio (M-H, Fixed, 95% CI)1.68 [0.33, 8.51]

 
Table 1. Description of the included studies

StudyCameronSomersZavotskyPurushothamJainSoonClasse

Participants
DG
NDG
20

20
108

119
24

22
190

185
58

29
36

51
51

47

Age, years
DG
NDG
50.0 ± 2.6

52.0 ± 2.7*
60.1 ± 12.8

59.3 ± 13.8*
58.2

59.6
57.6

57.7
61.9 ± 13.2

62.3 ± 12.3*
59

58
60 ± 10

58 ± 11*

OperationNSLumpectomyBCTWLE: 185

Mast: 190
Mastectomy/WLEMastectomy/

partial mastectomy
BCT

Type of drainSingle closed suction (RedivacTM)Jackson-Pratt closed suctionJackson-Pratt

closed suction
Single Portovac®Single 14-Fr vacuum (Medinorm®)1 closed suction drainNS (suction implied)

Time of drain removal< 25 mL/24 h24 hours postoperative< 30 mL/24 h< 50 mL/24 h or 5 d< 50 mL/24 h24 to 48 hours postop< 35 mL/24 h

Level of ALND"cleared below axillary vein"I and III, II and a portion of III

Complete III if grossly palpable axillary nodes
III and II"all tissue inferior to axillary vein removed"I and II

Lymph nodes removed
DG
NDG
NS
NS
15.7 ± 5.7*
16.7 ± 5.7*
15.3

15.7
NS

NS
7.1 ± 2.8*

8.2 ± 3.4*
16

17.5
NS

NS

 *: mean ± standard deviation.
: median.
ALND: axillary lymph node dissection.
BCT: breast-conserving therapy.
DG: drainage.
NDG: no drainage.
NS: not stated.
WLE: wide local excision.
Mast: mastectomy.