Appendix
Appendix 1. PRISMA 2009 Checklist
Section/topic
#
Checklist item
Reported on page #
1
Identify the report as a systematic review, metaanalysis, or both.
1
2
Provide a structured summary including, as applicable:
background; objectives; data sources; study eligibility
criteria, participants, and interventions; study appraisal
and synthesis methods; results; limitations;
conclusions and implications of key findings;
systematic review registration number.
1
Rationale
3
Describe the rationale for the review in the context of
what is already known.
2
Objectives
4
Provide an explicit statement of questions being
addressed with reference to participants, interventions,
comparisons, outcomes, and study design (PICOS).
2; Appendix 2
Protocol and
registration
5
Indicate if a review protocol exists, if and where it can
be accessed (e.g., Web address), and, if available,
provide registration information including registration
number.
PROSPERO registration
number:
CRD42014014265
Eligibility criteria
6
Specify study characteristics (e.g., PICOS, length of
follow-up) and report characteristics (e.g., years
considered, language, publication status) used as
criteria for eligibility, giving rationale.
3
Information
sources
7
Describe all information sources (e.g., databases with
dates of coverage, contact with study authors to
identify additional studies) in the search and date last
searched.
3
Search
8
Present full electronic search strategy for at least one
database, including any limits used, such that it could
be repeated.
3; Appendix 3, 4 & 5
Study selection
9
State the process for selecting studies (i.e., screening,
eligibility, included in systematic review, and, if
applicable, included in the meta-analysis).
3
Data collection
process
10
Describe method of data extraction from reports (e.g.,
piloted forms, independently, in duplicate) and any
processes for obtaining and confirming data from
investigators.
4; Appendix 8
Data items
11
List and define all variables for which data were sought
(e.g., PICOS, funding sources) and any assumptions
and simplifications made.
4
Risk of bias in
individual
studies
12
Describe methods used for assessing risk of bias of
individual studies (including specification of whether
this was done at the study or outcome level), and how
this information is to be used in any data synthesis.
4; Appendix 7
TITLE
Title
ABSTRACT
Structured
summary
INTRODUCTION
METHODS
1
Summary
measures
13
State the principal summary measures (e.g., risk ratio,
difference in means).
4-5
Synthesis of
results
14
Describe the methods of handling data and combining
results of studies, if done, including measures of
consistency (e.g., I2) for each meta-analysis.
4-5
Risk of bias
across studies
15
Specify any assessment of risk of bias that may affect
the cumulative evidence (e.g., publication bias,
selective reporting within studies).
Funnel plot was
presented in Appendix
9.
Additional
analyses
16
Describe methods of additional analyses (e.g.,
sensitivity or subgroup analyses, meta-regression), if
done, indicating which were pre-specified.
Subgroup analysis was
not performed due to
low heterogeneity
across the included
studies in each of the
study outcome.
Study selection
17
Give numbers of studies screened, assessed for
eligibility, and included in the review, with reasons for
exclusions at each stage, ideally with a flow diagram.
6; Figure 1.
Study
characteristics
18
For each study, present characteristics for which data
were extracted (e.g., study size, PICOS, follow-up
period) and provide the citations.
6-9; Table 1, 2, 3, 4
Risk of bias
within studies
19
Present data on risk of bias of each study and, if
available, any outcome level assessment (see item
12).
9; Table 1, Table 3
Results of
individual
studies
20
For all outcomes considered (benefits or harms),
present, for each study: (a) simple summary data for
each intervention group (b) effect estimates and
confidence intervals, ideally with a forest plot.
6-9; Table 1, 2, 3, 4
Synthesis of
results
21
Present results of each meta-analysis done, including
confidence intervals and measures of consistency.
9-10; Appendix 9
Risk of bias
across studies
22
Present results of any assessment of risk of bias
across studies (see Item 15).
Funnel plot was
presented in Appendix
9.
Additional
analysis
23
Give results of additional analyses, if done (e.g.,
sensitivity or subgroup analyses, meta-regression [see
Item 16]).
Subgroup analysis was
not performed due to
low heterogeneity
across the included
studies in each of the
study outcome.
Summary of
evidence
24
Summarize the main findings including the strength of
evidence for each main outcome; consider their
relevance to key groups (e.g., healthcare providers,
users, and policy makers).
13
Limitations
25
Discuss limitations at study and outcome level (e.g.,
risk of bias), and at review-level (e.g., incomplete
retrieval of identified research, reporting bias).
13-14
Conclusions
26
Provide a general interpretation of the results in the
context of other evidence, and implications for future
research.
15
27
Describe sources of funding for the systematic review
and other support (e.g., supply of data); role of funders
no funding source
(disclosed in title page)
RESULTS
DISCUSSION
FUNDING
Funding
2
for the systematic review.
From: Moher D, Liberati A, Tetzlaff J, Altman DG, The PRISMA Group (2009). Preferred Reporting Items for Systematic Reviews and
Meta-Analyses: The PRISMA Statement. PLoS Med 6(6): e1000097. doi:10.1371/journal.pmed1000097
3
Appendix 2. PICOS
Population
Patients receiving breast augmentation with implants
Intervention
Perioperative povidone-iodine irrigation
Comparison
Perioperative saline irrigation
Outcomes
Incidence of Baker class III/IV capsular contracture
Incidence of implant deflation as the major side effect of povidone-iodine contact
Study design
RCTs, cohort studies and case-control studies were all included to compare the
incidence of capsular contracture between the povidone-iodine irrigation and
saline irrigation; case series were also included to evaluate the side effect of the
use of povidone-iodine (implant deflation)
4
Appendix 3. Search results from MEDLINE/PubMed through December 2014
Steps
#1
#2
#3
#4
Query
"Mammaplasty"[Mesh] OR "Mammaplasty"[all fields] OR
“Mammaplasties”[all fields] OR “Mammoplasty”[all fields] OR
“Mammoplasties”[all fields] OR “Breast augmentation” [all fields]
“Implant Capsular Contracture”[Mesh] OR “Implant Capsular
Contracture”[all fields] OR “Capsular Contracture”[all fields]
"povidone-iodine"[MeSH Terms] OR "povidone-iodine"[all fields]
OR "Betadine"[all fields]
#1 AND #2 AND #3
Items found
10,749
941
3274
9
Appendix 4. Search results from EMBASE through December 2014
#2
Query
'Mammaplasty' OR 'Mammaplasties' OR 'Mammoplasty' OR
'Mammoplasties' OR ' Breast augmentation'
'Implant Capsular Contracture' OR 'Capsular Contracture'
#3
'Povidone iodine' OR 'betadine'
#4
#1 AND #2 AND #3
Steps
#1
Items found
15,653
1,067
8,571
18
Appendix 5. Search results from SCOPUS through December 2014
Steps
#1
#2
#3
#4
Query
TITLE-ABS-KEY(Mammaplasty) OR TITLE-ABSKEY(Mammoplasty) OR TITLE-ABS-KEY(Breast augmentation)
TITLE-ABS-KEY ( implant capsular contracture ) OR TITLEABS-KEY ( capsular contracture )
TITLE-ABS-KEY(Povidone iodine) OR TITLE-ABSKEY(Betadine)
#1 AND #2 AND #3
5
Items found
12,698
1,392
9,018
21
Appendix 6. List of excluded studies
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
Citations
Spear SL, Murphy DK; Allergan Silicone Breast Implant U.S. Core
Clinical Study Group. Natrelle round silicone breast implants: Core Study
results at 10 years. Plast Reconstr Surg. 2014 Jun;133(6):1354-61.
Maxwell GP, Scheflan M, Spear S, Nava MB, Hedén P. Benefits and
Limitations of Macrotextured Breast Implants and Consensus
Recommendations for Optimizing Their Effectiveness. Aesthet Surg J.
2014 Jul 14;34(6):876-881.
Antony AK, McCarthy C, Disa JJ, Mehrara BJ. Bilateral implant breast
reconstruction: outcomes, predictors, and matched cohort analysis in 730
2-stage breast reconstructions over 10 years. Ann Plast Surg. 2014
Jun;72(6):625-30.
Wiener TC. Betadine and breast implants: an update. Aesthet Surg J. 2013
May;33(4):615-7.
Park SO, Han J, Minn KW, Jin US. Prevention of capsular contracture
with Guardix-SG(®) after silicone implant insertion. Aesthetic Plast Surg.
2013 Jun;37(3):543-8.
Blount A.L., Martin M.D., Lineberry K.D., Kettaneh N., Alfonso D.R.
Capsular contracture rate in a low-risk population after primary
augmentation mammaplasty Aesthetic Surgery Journal 2013 33:4(516521)
Craft R.O., Damjanovic B., Colwell A.S. Evidence-based protocol for
infection control in immediate implant-based breast reconstruction.
Annals of plastic surgery 2012 69:4(446-450)
Wiener T.C. Minimizing capsular contracture in a "clean-contaminated
site" Aesthetic Surgery Journal 2012 32:3(352-353)
McHugh S.M., Collins C.J., Corrigan M.A., Hill A.D.K., Humphreys H.
The role of topical antibiotics used as prophylaxis in surgical site
infection prevention. Journal of Antimicrobial Chemotherapy 2011
66:4(693-701)
Khan UD. Breast augmentation, antibiotic prophylaxis, and infection:
comparative analysis of 1,628 primary augmentation mammoplasties
assessing the role and efficacy of antibiotics prophylaxis duration.
Aesthetic Plast Surg. 2010 Feb;34(1):42-7.
Marques M, Brown SA, Oliveira I, Cordeiro MN, Morales-Helguera A,
Rodrigues A, Amarante J. Long-term follow-up of breast capsule
contracture rates in cosmetic and reconstructive cases Plast Reconstr
Surg. 2010 Sep;126(3):769-78.
Pfeiffer P, Jørgensen S, Kristiansen TB, Jørgensen A, Hölmich LR.
Protective effect of topical antibiotics in breast augmentation. Plast
Reconstr Surg. 2009 Aug;124(2):629-34.
Adams WP Jr. Capsular Contracture: What is It? What Causes It? How
Can It Be Prevented and Managed? Clin Plast Surg. 2009 Jan;36(1):11926
Stevens WG, Pacella SJ, Hirsch E, Stoker DA Patient retention and
replacement trends after saline breast implants: are deflations
inflationary? Aesthetic Plast Surg. 2009 Jan;33(1):54-7.
Gravante G., Caruso R., Araco A., Cervelli V. Infections after plastic
procedures: Incidences, etiologies, risk factors, and antibiotic prophylaxis.
Aesthetic Plastic Surgery 2008 32:2(243-251)
Gampper T.J., Khoury H., Gottlieb W., Morgan R.F. Silicone gel implants
in breast augmentation and reconstruction. Annals of Plastic Surgery 2007
59:5(581-590)
Zambacos GJ, Mandrekas AD, Morris RJ. The role of betadine irrigation
in breast augmentation. Plast Reconstr Surg. 2007 Dec;120(7):2115;
author reply 2116.
Araco A, Gravante G, Araco F, Delogu D, Cervelli V, Walgenbach K.
6
Reason(s) for Exclusion
No description of perioperative
povidone-iodine use
No description of perioperative
povidone-iodine use
Study on breast reconstruction
Review article
Animal study
Less than 3% of the study
population receiving Betadine
irrigation (page 517)
Study on breast reconstruction
Letter to editor
Review article
Use of povidone-iodine in
infected cases (page 44)
No description of perioperative
management
Comparing use with and without
cephalothin in perioperative
implant irrigation
Review article
Not evaluating the use of
povidone-iodine in breast
augmentation surgery
Review article
Review article
Letter to editor
Same patient group to included
19
20
21
22
23
24
25
26
27
28
Infections of breast implants in aesthetic breast augmentations: a singlecenter review of 3,002 patients. Aesthetic Plast Surg. 2007 JulAug;31(4):325-9.
Sevin A, Sevin K, Senen D, Deren O, Adanali G, Erdogan B.
Augmentation mammaplasty: retrospective analysis of 210 cases.
Aesthetic Plast Surg. 2006 Nov-Dec;30(6):651-4.
Henriksen TF, Fryzek JP, Hölmich LR, McLaughlin JK, Kjøller K, Høyer
AP, Olsen JH, Friis S. Surgical intervention and capsular contracture after
breast augmentation: a prospective study of risk factors. Ann Plast Surg.
2005 Apr;54(4):343-51.
Henriksen TF, Hölmich LR, Fryzek JP, Friis S, McLaughlin JK, Høyer
AP, Kjøller K, Olsen JH. Incidence and severity of short-term
complications after breast augmentation: results from a nationwide breast
implant registry. Ann Plast Surg. 2003 Dec;51(6):531-9.
Brandon HJ, Young VL, Jerina KL, Wolf CJ, Adams WP Jr, Watson ME.
Mechanical analysis of explanted saline-filled breast implants exposed to
betadine pocket irrigation. Aesthet Surg J. 2002 Sep;22(5):438-45.
Adams WP Jr, Conner WC, Barton FE Jr, Rohrich RJ. Optimizing breastpocket irrigation: the post-betadine era. Plast Reconstr Surg. 2001
May;107(6):1596-1601.
Fagrell D, Berggren A, Tarpila E. Capsular contracture around salinefilled fine textured and smooth mammary implants: a prospective 7.5-year
follow-up. Plast Reconstr Surg. 2001 Dec;108(7):2108-12; discussion
2113.
Adams WP Jr, Conner WC, Barton FE Jr, Rohrich RJ. Optimizing breast
pocket irrigation: an in vitro study and clinical implications. Plast
Reconstr Surg. 2000 Jan;105(1):334-8; discussion 339-43.
Spear SL, Elmaraghy M, Hess C. Textured-surface saline-filled silicone
breast implants for augmentation mammaplasty. Plast Reconstr Surg.
2000 Apr;105(4):1542-52; discussion 1553-4.
Rohrich R.J., Kenkel J.M., Adams W.P. Preventing capsular contracture in
breast augmentation: In search of the Holy Grail. Plastic and
Reconstructive Surgery 1999 103:6(1759-1760)
LeRoy J., Given K.S. Wound infection in breast augmentation: The role
of prophylactic perioperative antibiotics. Aesthetic Plastic Surgery 1991
15:4(303-305)
7
case series
No description of perioperative
povidone-iodine use
No description of perioperative
povidone-iodine use
No description of perioperative
povidone-iodine use
Evaluating the explanted saline
implant with exposure to
povidone-iodine irrigated pocked
in vitro study
No description of perioperative
povidone-iodine use
in vitro study
Review article
Commentary
Less than 3% of the study
population receiving Betadine
irrigation (Page 303)
Appendix 7. Methodology quality assessment of included articles

Randomized controlled trials (Level of evidence: II)
We assessed the methodological quality of randomized controlled trials (RCTs) using the Jadad
scale. On the basis of the Jadad score, quality of reporting was categorized as poor (Jadad score < 3)
or good (Jadad score ≥ 3). (Reference: Jadad AR, Moore RA, Carroll D et al. Assessing the quality
of reports of randomized clinical trials: is blinding necessary? Control Clin Trials 1996; 17:1-12.)
Citation #1. Burkhardt BR, Dempsey PD, Schnur PL, Tofield JJ. Capsular contracture: a
prospective study of the effect of local antibacterial agents. Plast Reconstr Surg. 1986
Jun;77(6):919-32. Total score: 2
Jadad Score Calculation
Was the study described as randomized?
Was the randomization procedure appropriate and reported in the study?
Was the study double blind?
Was the double blinding method appropriate and reported in the study?
Are the reasons for patient withdrawals and dropouts described, for each treatment
group?
Deduct one point if the method of randomization was described, but was
inappropriate.
Deduct one point if the method of blinding was described, but was inappropriate.
Reported
on Page#
Score
919
919
919
920
-
1
0
1
1
0
919
-1
-
-
2
Total
Citation #2. Burkhardt BR, Demas CP. The effect of Siltex texturing and povidone-iodine irrigation
on capsular contracture around saline inflatable breast implants. Plast Reconstr Surg. 1994
Jan;93(1):123-8; Total score: 4
Jadad Score Calculation
Was the study described as randomized?
Was the randomization procedure appropriate and reported in the study?
Was the study double blind?
Was the double blinding method appropriate and reported in the study?
Are the reasons for patient withdrawals and dropouts described, for each
treatment group?
Deduct one point if the method of randomization was described, but was
inappropriate.
Deduct one point if the method of blinding was described, but was inappropriate.
Reported
on Page#
Score
123
123
123
124
-
1
1
1
1
0
-
-
-
-
4
Total
8
Citation #3. Burkhardt BR, Eades E. The effect of Biocell texturing and povidone-iodine
irrigation on capsular contracture around saline-inflatable breast implants. Plast Reconstr Surg.
1995 Nov;96(6):1317-25. Total score: 4
Jadad Score Calculation
Was the study described as randomized?
Was the randomization procedure appropriate and reported in the study?
Was the study double blind?
Was the double blinding method appropriate and reported in the study?
Are the reasons for patient withdrawals and dropouts described, for each
treatment group?
Deduct one point if the method of randomization was described, but was
inappropriate.
Deduct one point if the method of blinding was described, but was inappropriate.
Reported
on Page#
Score
1317
1317
1317
1317-8
1318
1
1
1
1
0
-
-
-
-
4
Total
The Cochrane Collaboration’s tool for assessing risk of bias
(Reference:
http://handbook.cochrane.org/chapter_8/8_assessing_risk_of_bias_in_included_studies.htm)
Burkhardt
BR 1986
Burkhardt
BR 1994
Burkhardt
BR 1995
Random sequence generation
Allocation concealment
Blinding of participants and personnel
Blinding of outcome assessment
Incomplete outcome data
Selective reporting
Other bias
Low risk of bias
High risk of bias
Unclear risk of bias
9

Case-controlled studies (Level of evidence: III)
For non-randomized controlled studies we used MINORS (Methodological Index for NonRandomized Studies) guidelines to assess the methodological quality. MINORS guidelines consist
of 12 indices: i) a clearly stated aim, ii) inclusion of consecutive patients, iii) prospective collection
of data, iv) endpoints appropriate to the aim of the study, v) unbiased assessment of the study
endpoint(s), vi) a follow-up period appropriate to the aim of the study, vii) loss to follow-up less
than 5%, viii) prospective calculation of the study size, ix) an adequate control group, x)
contemporary groups (control and studied group should be managed during the same time period,
no historical comparison), xi) baseline equivalence of groups and xii) an adequate statistical
analyses. Every item has two scores for a total score of 24; a score ≥16 points indicates high quality,
otherwise the quality is low (<16 points).
Reference: Slim K, Nini E, Forestier D, Kwiatkowski F, Panis Y, Chipponi J. Methodological index
for non-randomized studies (minors): development and validation of a new instrument. ANZ J Surg.
2003 Sep;73(9):712-6.
Citation #4. Wiener TC. The role of betadine irrigation in breast augmentation. Plast Reconstr
Surg. 2007 Jan;119(1):12-5; Total score: 12
Items
Description
Reported on Page#
Score
1
A clearly stated aim
13
2
2
Inclusion of consecutive patients
13
2
3
Prospective collection of data
-
0
4
Endpoints appropriate to the aim of the study
13-14
2
5
Unbiased assessment of the study endpoint
13
1
6
Follow-up period appropriate to the aim of the study
14
1
7
Loss to follow-up less than 5%
14
1
8
Prospective calculation of the study size
-
0
9
Adequate control group
13
1
10
Contemporary groups
-
0
11
Baseline equivalence of groups
13
1
12
Adequate statistical analyses
13-14
1
The items are scored 0 (not reported), 1 (reported but inadequate) or 2 (reported and adequate).
10
Citation #5. Giordano S, Peltoniemi H, Lilius P, Salmi A. Povidone-iodine combined with
antibiotic topical irrigation to reduce capsular contracture in cosmetic breast augmentation: a
comparative study. Aesthetic surgery journal / the American Society for Aesthetic Plastic surgery.
2013;33(5):675-80. Total score: 17
Items
Description
Reported on Page#
Score
1
A clearly stated aim
676
2
2
Inclusion of consecutive patients
676
2
3
Prospective collection of data
-
0
4
Endpoints appropriate to the aim of the study
676-677
2
5
Unbiased assessment of the study endpoint
676
1
6
Follow-up period appropriate to the aim of the study
677
2
7
Loss to follow-up less than 5%
677
2
8
Prospective calculation of the study size
-
0
9
Adequate control group
676
2
10
Contemporary groups
-
0
11
Baseline equivalence of groups
677
2
12
Adequate statistical analyses
677
2
The items are scored 0 (not reported), 1 (reported but inadequate) or 2 (reported and adequate).
11

Case series (Level of evidence: IV)
Citation #6. Adams WP Jr, Rios JL, Smith SJ. Enhancing patient outcomes in aesthetic and
reconstructive breast surgery using triple antibiotic breast irrigation: six-year prospective clinical
study. Plast Reconstr Surg. 2006 Dec;118(7 Suppl):46S-52S. Total score: 13
Items
Description
Reported on Page#
Score
1
A clearly stated aim
31
2
2
Inclusion of consecutive patients
31
2
3
Prospective collection of data
31
2
4
Endpoints appropriate to the aim of the study
32
2
5
Unbiased assessment of the study endpoint
32
1
6
Follow-up period appropriate to the aim of the study
32
2
7
Loss to follow-up less than 5%
32
2
8
Prospective calculation of the study size
-
0
9
Adequate control group
-
0
10
Contemporary groups
-
0
11
Baseline equivalence of groups
-
0
12
Adequate statistical analyses
-
0
The items are scored 0 (not reported), 1 (reported but inadequate) or 2 (reported and adequate).
Citation #7. Araco A, Gravante G, Araco F, Delogu D, Cervelli V, Walgenbach K. A retrospective
analysis of 3,000 primary aesthetic breast augmentations: postoperative complications and
associated factors. Aesthetic Plast Surg. 2007 Sep-Oct;31(5):532-9. Total score: 12
Items
Description
Reported on Page#
Score
1
A clearly stated aim
533
2
2
Inclusion of consecutive patients
533
2
3
Prospective collection of data
-
0
4
Endpoints appropriate to the aim of the study
534-536
2
5
Unbiased assessment of the study endpoint
533
2
6
Follow-up period appropriate to the aim of the study
534
2
7
Loss to follow-up less than 5%
-
0
8
Prospective calculation of the study size
-
0
9
Adequate control group
-
0
10
Contemporary groups
-
0
11
Baseline equivalence of groups
-
0
12
Adequate statistical analyses
534
2
The items are scored 0 (not reported), 1 (reported but inadequate) or 2 (reported and adequate).
12
Citation #8. Stevens WG, Pacella SJ, Gear AJ, Freeman ME, McWhorter C, Tenenbaum MJ,
Stoker DA. Clinical experience with a fourth-generation textured silicone gel breast implant: a
review of 1012 Mentor MemoryGel breast implants. Aesthet Surg J. 2008 Nov-Dec;28(6):642-7.
Total score: 10
Items
Description
Reported on Page#
Score
1
A clearly stated aim
643
2
2
Inclusion of consecutive patients
643
2
3
Prospective collection of data
-
0
4
Endpoints appropriate to the aim of the study
643-644
2
5
Unbiased assessment of the study endpoint
-
0
6
Follow-up period appropriate to the aim of the study
643
2
7
Loss to follow-up less than 5%
-
0
8
Prospective calculation of the study size
-
0
9
Adequate control group
-
0
10
Contemporary groups
-
0
11
Baseline equivalence of groups
-
0
12
Adequate statistical analyses
643
2
The items are scored 0 (not reported), 1 (reported but inadequate) or 2 (reported and adequate).
Citation #9. Stevens WG, Hirsch EM, Tenenbaum MJ, Acevedo M. A prospective study of 708
form-stable silicone gel breast implants. Aesthet Surg J. 2010 Sep;30(5):693-701. Total score: 11
Items
Description
Reported on Page#
Score
1
A clearly stated aim
694
2
2
Inclusion of consecutive patients
694
1
3
Prospective collection of data
694
1
4
Endpoints appropriate to the aim of the study
695-698
2
5
Unbiased assessment of the study endpoint
695
1
6
Follow-up period appropriate to the aim of the study
695
2
7
Loss to follow-up less than 5%
-
0
8
Prospective calculation of the study size
-
0
9
Adequate control group
-
0
10
Contemporary groups
-
0
11
Baseline equivalence of groups
-
0
12
Adequate statistical analyses
695
2
The items are scored 0 (not reported), 1 (reported but inadequate) or 2 (reported and adequate).
13
Appendix 8. Data collection process
Author, Year
Burkhardt et al., 1986
Burkhardt et al., 1994*
Burkhardt et al., 1995
Wiener, 2007
No. of breasts/patients receiving primary breast augmentation with
implants
Povidone-iodine irrigation
Saline irrigation
71
37
(Group 2: 38 + Group 3: 33)
(Group 5)
56
52
52
(Group 2: 28 + Group 4: 24)
(Group 1: 24 + Group 3: 28)
903
341
(Group I, III, IV)
(Group II)
165
165
165
2824
126
176
-
Total
108
56
104
1244
330
Giordano et al., 2013
165
Adams et al., 2006,
2824
Araco et al., 2007,
126
Stevens et al., 2008
176
Stevens et al., 2010
* The exact number of patients in the povidone-iodine and saline groups were not presented in the
text. They were expressed in the figure without detailed numbers.
Total number of patients receiving primary breast augmentation with implants in the included 9
studies: 5153
Total number of patients with primary breast augmentation that received perioperative povidoneiodine irrigation: 4482 (unknown number of patients from Burkhardt et al. 1994 may be added)
Author, Year
Burkhardt et al., 1986
Burkhardt et al., 1995
Wiener, 2007
Giordano et al., 2013
Total
No. of patients developed Baker class III/IV capsular contracture
Povidone-iodine irrigation
Saline irrigation
13
15
(Group 2: 7 + Group 3: 6)
(Group 5)
5
14
(Group 2: 4 + Group 4: 1)
(Group 1: 8 + Group 3: 6)
13
14
(Group 1: 7 + III: 5 + IV:1)
(Group II)
1
10
32
53
Total number of patients receiving primary breast augmentation allocated to the povidone-iodine
irrigation group in the meta-analysis: 1191
32 cases (2.7%) developed Baker grade III/IV capsular contracture
Total number of patients receiving primary breast augmentation allocated to the saline irrigation
group in the meta-analysis: 595
53 cases (8.9%) developed Baker III-IV capsular contracture
14
Appendix 9. Data synthesis process
RevMan 5.3 (Review Manager Version 5.3, Copenhagen: The Nordic Cochrane Center, The
Cochrane Collaboration, 2012) was used for meta-analysis. Results of the meta-analysis were
assessed using odds ratios (OR) with 95% confidence intervals (CI) within a random effects model.
The Mantel-Haenzsel method was used for dichotomous outcomes. We explored variability in study
outcomes by calculating statistical heterogeneity with chi-square and inconsistency (I2) statistics; an
I2 value of 50% or more represented substantial heterogeneity.
We included four studies with available data for meta-analysis. Patients that received irrigation with
antimicrobial solution (povidone-iodine solution with or without other antibiotics in solution) were
categorized to the povidone-iodine irrigation group. Patients in the control group received saline
irrigation. Thus, 1191 patients were allocated to the povidone-iodine irrigation group and 595
patients to saline irrigation group.
Author, Year
Burkhardt et al., 1986
Burkhardt et al., 1995
Wiener, 2007
Giordano et al., 2013
No. of patients receiving primary breast augmentation with
implants
Povidone-iodine irrigation
Saline irrigation
71
37
(Group 2: 38 + Group 3: 33)
(Group 5)
52
52
(Group 2: 28 + Group 4: 24)
(Group 1: 24 + Group 3: 28)
903
341
(Group I, III, IV)
(Group II)
165
165
15
Total
108
104
1244
330
The meta-analysis demonstrated the use of povidone-iodine irrigation to have a lower rate of
capsular contracture when compared to saline irrigation (2.7% vs. 8.9%; OR: 0.30; 95% CI, 0.18 0.50; P <0.00001). Studies were of low heterogeneity (I2 = 0 %; P = 0.70).
Figure A. The forest plot showed the odds ratio of capsular contracture in the Betadine (povidoneiodine) irrigation group and the saline irrigation group with random effects model meta-analysis.
Betadine irrigation
Study or Subgroup
Saline irrigation
Events
Total
Events
Burkhardt 1986
13
71
15
Burkhardt 1995
5
52
Giordano 2013
1
165
13
953
Wiener 2007
Total (95% CI)
Total events
Total Weight
Odds Ratio
M-H, Random, 95% CI
37
31.4%
0.33 [0.13, 0.80]
14
52
20.3%
0.29 [0.10, 0.87]
10
165
5.8%
0.09 [0.01, 0.75]
14
341
42.5%
0.32 [0.15, 0.69]
595 100.0%
0.30 [0.18, 0.49]
1241
32
Odds Ratio
M-H, Random, 95% CI
53
Heterogeneity: Tau² = 0.00; Chi² = 1.33, df = 3 (P = 0.72); I² = 0%
0.01
Test for overall effect: Z = 4.79 (P < 0.00001)
0.1
Favours Betadine
Figure B. assessment of publication bias by using the funnel plot
16
1
10
Favours saline
100