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Intervention Review

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Wound drainage after plastic and reconstructive surgery of the breast

  1. Christa A Stojkovic1,*,
  2. Mark J C Smeulders1,
  3. Chantal M Van der Horst1,
  4. Sameena M Khan2

Editorial Group: Cochrane Wounds Group

Published Online: 28 MAR 2013

Assessed as up-to-date: 3 AUG 2012

DOI: 10.1002/14651858.CD007258.pub2


How to Cite

Stojkovic CA, Smeulders MJC, Van der Horst CM, Khan SM. Wound drainage after plastic and reconstructive surgery of the breast. Cochrane Database of Systematic Reviews 2013, Issue 3. Art. No.: CD007258. DOI: 10.1002/14651858.CD007258.pub2.

Author Information

  1. 1

    Academic Medical Centre, Department of Plastic, Reconstructive and Hand Surgery, Amsterdam, Netherlands

  2. 2

    University of York, Department of Health Sciences, York, UK

*Christa A Stojkovic, Department of Plastic, Reconstructive and Hand Surgery, Academic Medical Centre, PO Box 22700, Amsterdam, 1100 DE, Netherlands. c.a.stojkovic@hotmail.com.

Publication History

  1. Publication Status: New
  2. Published Online: 28 MAR 2013

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This is not the most recent version of the article. View current version (21 OCT 2015)

 
Characteristics of included studies [ordered by study ID]
Collis 2005

MethodsRandomised controlled trial, with two breasts in each patient being randomised.


ParticipantsNumber: 150 patients enrolled (300 breasts) (mean age 37 years; mean BMI 29 (range 18-40)):

  •  inferior pedicle technique 141;
  •  superomedial pedicle 9;
  •  25% of total > 1000g reduction per breast (mean 799g).


Inclusion criteria: routine bilateral breast reduction surgery, female patients.
Exclusion criteria: one patient excluded after the drain was accidentally avulsed in the early post-operative period.


InterventionsIntervention 1: unilateral Bellovac closed suction drain in one breast.
Intervention 2: no drain in the other breast (on the same patient). 

Drain removed when production < 30 ml in 24 hours:

  •  43% removed on 1st post-operative day;
  •  49% removed on 2nd post-operative day;
  •  7% removed on 3rd + 4rd post-operative day.


Mean volume drained 72 ml (range 0-392 ml).
No mention of antibiotic use.


OutcomesHaematoma (surgically drained); spontaneous haematoma drainage; minor wound healing (skin loss <1 cm2); major wound healing (skin loss > 1 cm2); fat necrosis; abscess drainage; minor infection; major infection; seroma aspiration; hypertrophic scarring; nipple loss.


NotesTrial location: UK. Setting: university hospital.
Follow up: 3 months.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: Participants were ‘prospectively randomised intra-operatively’

Did not report randomisation procedure. Each participant acted as their own control. Unit of randomisation was the breast.

Allocation concealment (selection bias)Unclear riskDid not report allocation concealment.

Blinding (performance bias and detection bias)
All outcomes
High riskEach participant had a bilateral breast reduction; one breast received a drain and the other did not. Binding could not be carried out in this setting.

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskIt is not clear whether the treatment provider (surgeon) was aware of which breast would receive a drain or when this was allocated. 

Blinding of outcome assessment (detection bias)
All outcomes
High riskEach participant had a bilateral breast reduction; one breast received a drain and the other did not. Binding of the outcome assessor could not be achieved irrespective of whether the drain was in situ at the time of assessment as there would have been a physical scar indicating the presence of a drain.

Incomplete outcome data (attrition bias)
All outcomes
Low riskQuote: ‘One patient was excluded after the drain was accidentally avulsed in the early post-operative period’

Reason for exclusion reported. It is not clear if this participant was included in the final analysis or not.  

Selective reporting (reporting bias)Low riskComment: Study protocol not available. However, the outcomes stated in the methods of the report were all described in the results and discussion.

Adequate follow up?Low riskAll participant data reported.

Intention-to-treat analysis?Unclear riskOne participant excluded due to drain avulsion- unclear if this participant was included in analysis.

Corion 2009

MethodsRandomised controlled trial, with patients individually randomised.
Selection of patients: October 2003-January 2005.


ParticipantsNumber: 107 patients enrolled (mean age 35 years; mean BMI 26 (range 20-40)):

  •  drain: 55 patients;
  •  no drain: 52 patients.


Mean volume of reduction: drained group 1110 g; no drain group 1085 g.
Inclusion criteria: bilateral breast reduction surgery, cranio-medial pedicle technique, female patients.
Exclusion criteria: patients on anticoagulant medication or with a history of coagulation disorders.


InterventionsGroup 1: patients with drains in both breasts.
Group 2. patients with no drains in either of their breasts.

Drains were removed when production was ≤ 20 ml for at least 24 hours.
Patients with drains were discharged on the day of drain removal unless they felt comfortable leaving hospital earlier with the drains still in place.

No antibiotics given.


OutcomesPrimary outcome:
Occurrence of a complication: haematoma; infection; oedema; necrosis; wound dehiscence.

Secondary outcome measures (visual analogue scale):
Pain; discomfort due to drains; satisfaction rate (satisfaction rate was not assessed in the review).


NotesLocation: The Netherlands. Setting: university medical centre.
Calculated sample size 100.
No pre- or peri-operative antibiotics or corticosteroids were given.
Patients were discharged as soon as they felt comfortable about leaving the hospital.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: Participants were ‘prospectively randomised during surgery’. Participants were ‘assigned…to one of two groups using a randomisation scheme’

Did not report randomisation procedure. Unit of randomisation was the participant.

Allocation concealment (selection bias)Low riskQuote: ‘An independent investigator (MS) who assigned the patient to one of the two groups’

Allocation concealment was achieved.

Blinding (performance bias and detection bias)
All outcomes
High riskBinding could not be carried out in this setting as the participant would have been aware of the presence of a drain or not.

Blinding of participants and personnel (performance bias)
All outcomes
Low riskQuote: ‘Patients were not assigned to the experimental groups until the subcutaneous sutures were placed’

The treatment provider (surgeon) was not aware if the patient would receive a drain or not till near completion of the surgical procedure.

Blinding of outcome assessment (detection bias)
All outcomes
High riskBinding of the outcome assessor could not be achieved irrespective of whether the drain was in situ at the time of assessment as there would have been a physical scar indicating the presence of a drain.

Incomplete outcome data (attrition bias)
All outcomes
Low riskQuote: ‘Intention to treat analysis was not performed, because all the patients received the treatment they were selected for’

No patient data lost.

Selective reporting (reporting bias)Low riskStudy protocol not available. However, the outcomes stated in the methods of the report were all described in the results and discussion.

Adequate follow up?Low riskAll participant data reported.

Intention-to-treat analysis?Low riskIntention to treat analysis carried out.

Wrye 2003

MethodsRandomised controlled trial, with two breasts in each patient being randomised.
Study duration: inclusion of patients from May 1999-March 2000, follow-up time ranging 5-17 months. Total duration: 27 months.


ParticipantsNumber: 49 patients enrolled (mean age 33 years; mean BMI not reported):

  • inferior pedicle technique 48;
  • amputation and free nipple grafting 1;


Small volume reductions (mean reduction 675 g; range 360-1090 g).

Inclusion criteria: (implied bilateral) breast reduction surgery, female patients.
Exclusion criteria:  not stated.


InterventionsIntervention 1: drain (no. 10 flat Blake or Jackson-Pratt) in one breast.
Intervention 2: no drain in the other breast (on the same patient).
All drains were removed one day after surgery.


OutcomesComplication rates for: partial nipple loss; wound breakdown; fat necrosis; haematoma; seroma; infection; hypertrophic scarring; difference in nipple sensation*; significant asymmetry*.

Patient satisfaction (via a post-operative questionnaires completed directly after surgery and 3 months later).

1st section: comfort level of each breast:

  •  pain;
  •  pinching*;
  •  drain getting caught*;
  •  drain removed due to discomfort*.


2nd section: long-term patient satisfaction*.
* Difference in nipple sensation, significant asymmetry, comfort level (except for pain) and patient satisfaction are not assessed in the review.


NotesLocation: United States. Setting: medical centre.
All patients received IV antibiotics peri-operatively, and oral antibiotics for 5 days post-operatively.
Follow up mean/average 9 months (range 5-17 months).
All patients were discharged the morning after surgery wearing sports brassieres, which they were to wear for the next 6 weeks.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskQuote: ‘Each patient was randomised to having a drain.. in either the right or left’

Did not report method of generating randomisation sequence. Each participant acted as their own control. Unit of randomisation was the breast.

Allocation concealment (selection bias)Unclear riskDid not report allocation concealment.

Blinding (performance bias and detection bias)
All outcomes
High riskEach participant had a bilateral breast reduction; one breast received a drain and the other did not. Binding could not be carried out in this setting.

Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskQuote: ‘Surgical technique did not differ between the three senior authors, with the exception of suture material used at the time of closing’

It is not clear whether the treatment provider (surgeon) was aware of which breast would receive a drain or when this was allocated. 

Blinding of outcome assessment (detection bias)
All outcomes
High riskBinding of the outcome assessor could not be achieved irrespective of whether the drain was in situ at the time of assessment as there would have been a physical scar indicating the presence of a drain.

Incomplete outcome data (attrition bias)
All outcomes
Low riskQuote: ‘Of the 30 questionnaires distributed, 19 were returned (63 percent)’

All participants’ data was available at the final outcome assessment for wound complications (primary outcome). However participants were followed up for a review of complications and patient satisfaction and this data were incomplete (40% of total participants).

Selective reporting (reporting bias)Low riskStudy protocol not available. However, the outcomes stated in the methods of the report were all described in the results and discussion.

Adequate follow up?Unclear riskAll participant data available for primary outcome though not reported by authors.

Intention-to-treat analysis?Unclear riskAnalysis in keeping with intention to treat for the assessment of wound complications but not stated.

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Burak 1997Did not study plastic or reconstructive surgery.

Cameron 1988Did not study plastic or reconstructive surgery.

Gupta 2001Did not study plastic or reconstructive surgery.

Johnson 2005Did not study plastic or reconstructive surgery. Furthermore, compared drain usage and fibrin sealant instead of drain usage versus no drain usage.

Purushotham 2002Did not study plastic or reconstructive surgery.

Rayatt 2005Did not compare drain usage to no drain usage, but compared one type of drain with another type.

 
Comparison 1. Drain compared with no drain

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

 1 Haematoma3505Risk Ratio (M-H, Fixed, 95% CI)1.19 [0.50, 2.80]

    1.1 Studies of poorer quality
2398Risk Ratio (M-H, Fixed, 95% CI)1.0 [0.29, 3.40]

    1.2 Study of high quality
1107Risk Ratio (M-H, Fixed, 95% CI)1.42 [0.42, 4.74]

 2 Infection3505Risk Ratio (M-H, Fixed, 95% CI)1.56 [0.73, 3.37]

    2.1 Studies of poorer quality
2398Risk Ratio (M-H, Fixed, 95% CI)1.14 [0.43, 3.07]

    2.2 Study of high quality
1107Risk Ratio (M-H, Fixed, 95% CI)2.52 [0.71, 8.99]

 3 Oedema1107Risk Ratio (M-H, Fixed, 95% CI)0.47 [0.04, 5.06]

 4 Seroma2398Risk Ratio (M-H, Fixed, 95% CI)1.0 [0.06, 15.84]

 5 Fat necrosis2398Risk Ratio (M-H, Fixed, 95% CI)2.5 [0.49, 12.70]

 6 (Partial) nipple loss3505Risk Ratio (M-H, Fixed, 95% CI)3.88 [0.44, 34.24]

    6.1 Studies of poorer quality
2398Risk Ratio (M-H, Fixed, 95% CI)3.0 [0.13, 71.89]

    6.2 Study of high quality
1107Risk Ratio (M-H, Fixed, 95% CI)4.73 [0.23, 96.30]

 7 Wound problems3505Risk Ratio (M-H, Fixed, 95% CI)1.07 [0.73, 1.57]

    7.1 Studies of poorer quality
2398Risk Ratio (M-H, Fixed, 95% CI)1.03 [0.69, 1.53]

    7.2 Study of high quality
1107Risk Ratio (M-H, Fixed, 95% CI)1.58 [0.40, 6.26]

 8 Pain1107Mean Difference (IV, Fixed, 95% CI)0.40 [-0.29, 1.09]

 9 Length of hospital stay (days)1107Mean Difference (IV, Fixed, 95% CI)0.77 [0.40, 1.14]

 10 Major complication3505Risk Ratio (M-H, Fixed, 95% CI)1.33 [0.56, 3.17]

 11 Major haematoma3505Risk Ratio (M-H, Fixed, 95% CI)0.85 [0.30, 2.40]

 12 Abscess drainage3505Risk Ratio (M-H, Fixed, 95% CI)3.59 [0.59, 21.64]

    12.1 Study of poorer quality
2398Risk Ratio (M-H, Fixed, 95% CI)3.0 [0.32, 28.52]

    12.2 Study of high quality
1107Risk Ratio (M-H, Fixed, 95% CI)4.73 [0.23, 96.30]