CD013099
CD013099
CD013099
Lin HS, Lin PT, Tsai YS, Wang SH, Chi CC.
Interventions for bacterial folliculitis and boils (furuncles and carbuncles).
Cochrane Database of Systematic Reviews 2018, Issue 8. Art. No.: CD013099.
DOI: 10.1002/14651858.CD013099.
www.cochranelibrary.com
Interventions for bacterial folliculitis and boils (furuncles and carbuncles) (Protocol)
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
TABLE OF CONTENTS
HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
ADDITIONAL TABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Interventions for bacterial folliculitis and boils (furuncles and carbuncles) (Protocol) i
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
[Intervention Protocol]
Huang-Shen Lin1 , Pei-Tzu Lin2,3 , Yu-Shiun Tsai4 , Shu-Hui Wang5 ,6 , Ching-Chi Chi7,8
1 Division of Infectious Diseases, Department of Internal Medicine, Chang Gung Memorial Hospital, Chiayi, Chiayi, Taiwan.
2 Department of Pharmacy, Chang Gung Memorial Hospital, Chiayi, Chiayi, Taiwan. 3 Department of Nursing, Chang Gung University
of Science and Technology, Chiayi, Taiwan. 4 Medical Library, Chang Gung Memorial Hospital, Chiayi, Puzih, Taiwan. 5 Department
of Dermatology, Far Eastern Memorial Hospital, New Taipei, Taiwan. 6 Graduate Institute of Applied Science and Engineering, College
of Science and Engineering, Fu Jen Catholic University, New Taipei, Taiwan. 7 College of Medicine, Chang Gung University, Taoyuan,
Taiwan. 8 Department of Dermatology, Chang Gung Memorial Hospital, Linkou, Taoyuan, Taiwan
Contact address: Ching-Chi Chi, Department of Dermatology, Chang Gung Memorial Hospital, Linkou, 5, Fuxing St, Guishan Dist,
Taoyuan, 33305, Taiwan. [email protected], [email protected].
Citation: Lin HS, Lin PT, Tsai YS, Wang SH, Chi CC. Interventions for bacterial folliculitis and boils (furuncles and carbuncles).
Cochrane Database of Systematic Reviews 2018, Issue 8. Art. No.: CD013099. DOI: 10.1002/14651858.CD013099.
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
ABSTRACT
This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:
To assess the effects of interventions (such as topical antibiotics, topical antiseptic agents, systemic antibiotics, phototherapy, and
incision and drainage) for people with bacterial folliculitis and boils.
Interventions for bacterial folliculitis and boils (furuncles and carbuncles) (Protocol) 2
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
to 2 minimal erythema dose (MED) has been used as treatment duct a systematic review to find and evaluate the best evidence on
for superficial folliculitis. Nisticò 2009 reported only mild adverse effects of available interventions for folliculitis and boils.
events such as local erythema.
Interventions for bacterial folliculitis and boils (furuncles and carbuncles) (Protocol) 3
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Types of outcome measures 2. US National Institutes of Health Ongoing Trials Register (
We will consider outcome data measured at ≤ 1 month and > 1 www.clinicaltrials.gov).
month as short-term and long-term outcomes, respectively. For 3. Australian New Zealand Clinical Trials Registry (
studies with multiple time points, we will consider data from www.anzctr.org.au).
longest follow-up only. 4. World Health Organization International Clinical Trials
Registry Platform ( ICTRP) ( apps.who.int/trialsearch/).
5. EU Clinical Trials Register ( www.clinicaltrialsregister.eu).
Primary outcomes
1. Clinical cure: clearance of all visible lesions of folliculitis or
Searching other resources
boils (i.e. disappearance of all papular or pustular lesions of
folliculitis or boils at the end of treatment)
2. Severe adverse events leading to withdrawal of treatment
Searching reference lists
We will check the bibliographies of included RCTs and any rele-
Secondary outcomes vant systematic reviews identified for further references to relevant
1. Quality of life: as measured by validated tools, including trials.
Dermatology Life Quality Index (DLQI), Short Form-36 (SF-
36), Skindex 29, Skindex 17, or Dermatology Quality of Life
Unpublished literature
Scale (DQOLS)
i) We will consider a DLQI score change of at least 5 as a We will contact the authors of reports of relevant RCTs published
minimally important difference (Khilji 2002) within the last three years to ask if they are aware of any relevant
2. Recurrence of folliculitis or boil following completion of unpublished data.
treatment
3. Minor adverse events not leading to withdrawal of
Adverse effects
treatment
We will not perform a separate search for adverse effects of inter-
ventions used for treatment of folliculitis and boils. We will con-
Search methods for identification of studies sider only adverse events described in included RCTs.
Interventions for bacterial folliculitis and boils (furuncles and carbuncles) (Protocol) 4
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Data extraction and management the results).
Two review authors (HL and PL) will independently extract data 3. High risk of bias when at least one domain is judged as
from the included RCTs using a data extraction form to col- being at high risk (plausible bias that seriously weakens
lect the following information: study methods, participants, in- confidence in the results).
terventions, outcomes, country, setting, and funding source (see We will determine the overall risk of bias for each outcome (across
Appendix 2). We have already pilot-tested the data extraction domains) across studies as follows (Higgins 2011).
form. We will use WebPlotDigitizer to extract data from figures 1. Most information is obtained from studies at low risk of
and graphs (WebPlotDigitizer 2017). We will use extracted data bias (plausible bias unlikely to seriously alter the results).
to create the ’Characteristics of included studies’ tables. If we en- 2. Most information is obtained from studies at low or unclear
counter disagreement about some data, the two review authors risk of bias (plausible bias that raises some doubt about the
will consult with a third review author (CC) to achieve unanimity. results).
One review author (PL) will enter the data into Review Manager 3. The proportion of information from studies at high risk of
5 (RevMan 2014), and another review author (HL) will recheck bias is sufficient to affect the interpretation of results (plausible
the entered data. bias that seriously weakens confidence in the results).
Two review authors (HL and PL) will independently assess the
risk of bias of included RCTs. We will discuss with a third review
Assessment of risk of bias in included studies author (CC) to resolve disagreements in assessment.
Interventions for bacterial folliculitis and boils (furuncles and carbuncles) (Protocol) 5
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Cluster-randomised trials Assessment of heterogeneity
For cluster-randomised trials that have not adjusted for clusters We will calculate the I² statistic to assess statistical heterogeneity
in their analysis, we will employ the Rao methods described in across the included trials. The importance of the observed value of
Chapter 16.3.4 in the Cochrane Handbook for Systematic Reviews of the I² statistic depends on (1) magnitude and direction of effects
Interventions (Higgins 2011; Rao 1992), and we will estimate the and (2) strength of evidence for heterogeneity (e.g. P value from
intervention effect assuming an intracluster correlation coefficient Chi² test, CI for I² statistic) (Higgins 2011). For the confidence
(ICC) of 0.05 . interval for an I² statistic, the rule of thumbs is as follows.
1. 0% to 40%: might not be important.
Interventions for bacterial folliculitis and boils (furuncles and carbuncles) (Protocol) 6
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
3. Methicillin-sensitive S aureus (MSSA) versus MRSA phototherapy versus sham light (see Types of outcome measures).
(including PVL gene type). When several major comparisons are reported, or when outcomes
4. Different dosages of an intervention. need to be summarised for different populations, we will produce
To test for subgroup differences, we will employ random-effects additional ’Summary of findings’ tables.
model analysis and will use the methods developed by Borenstein Two review authors (HL and PL) will assess the quality of the
2008 , which have been implemented in Review Manager software body of evidence using the five Grading of Recommendations
(RevMan 2014). Assessment, Development and Evaluation (GRADE) considera-
tions: study limitations, consistency of effect, imprecision, indi-
rectness, and publication bias (Schünemann 2013). The certainty
Sensitivity analysis (or quality) of evidence can be downgraded from high to moder-
If possible, we will conduct a sensitivity analysis to examine in- ate, low, or very low based on the five considerations stated above.
tervention effects after excluding trials with high risk of bias for We will resolve disagreements by discussion with a third review
one or more domains for the associated outcome. We will also author (CC). We will use GRADEpro GDT (GRADEpro GDT
conduct a sensitivity analysis by assuming that those with missing 2015) to prepare ’Summary of findings’ tables and to assess the
dichotomous outcome data experienced treatment success. certainty of evidence.
REFERENCES
Interventions for bacterial folliculitis and boils (furuncles and carbuncles) (Protocol) 8
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
source on the blood flow response of the skin. Archives of Clinical Infectious Diseases 2008;47(6):735–43. DOI:
Dermatology Research 2009;301(8):581–5. DOI: 10.1007/ 10.1086/591126; PUBMED: 18694344
s00403-009-0957-3
Tierney 2007
Rao 1992
Tierney JF, Stewart LA, Ghersi D, Burdett S, Sydes MR.
Rao JNK, Scott AJ. A simple method for the analysis of
Practical methods for incorporating summary time-to-event
clustered binary data. Biometrics 1992;48(2):577–85. DOI:
data into meta-analysis. Trials 2007;8:16. DOI: 10.1186/
10.2307/2532311
1745-6215-8-16; PUBMED: 17555582
RevMan 2014 [Computer program]
The Nordic Cochrane Centre, The Cochrane Collaboration. Tran 2017
Review Manager (RevMan) 5.3. Copenhagen: The Nordic Tran K, Wright MD. Topical antibiotics for infected
Cochrane Centre, The Cochrane Collaboration, 2014. dermatitis: a review of the clinical effectiveness and
Schünemann 2013 guidelines (CADTH rapid response report: summary
Schünemann H, Bro ek J, Guyatt G, Oxman A, editors. with critical appraisal). www.cadth.ca/topical-antibiotics-
GRADE Handbook for Grading Quality of Evidence and infected-dermatitis-review-clinical-effectiveness-and-
Strength of Recommendations. The GRADE Working guidelines. Canadian Agency for Drugs and Technologies in
Group, 2013. Health, (accessed 18 March 2018). [PUBMED: 29528606]
Shallcross 2015 WebPlotDigitizer 2017 [Computer program]
Shallcross LJ, Hayward AC, Johnson AM, Petersen I. Ankit Rohatgi. WebPlotDigitizer. Austin, Texas, USA:
Evidence for increasing severity of community-onset Ankit Rohatgi, October 2017.
boils and abscesses in UK general practice. Epidemiology
and Infection 2015;143(11):2426–9. DOI: 10.1017/ Zacherle 1982
S0950268814003458; PUBMED: 25530161 Zacherle BJ, Silver DS. Hot tub folliculitis: a clinical
Shehab 2008 syndrome. Western Journal of Medicine 1982;137(3):191–4.
Shehab N, Patel PR, Srinivasan A, Budnitz DS. Emergency [PUBMED: 7147933]
∗
department visits for antibiotic-associated adverse events. Indicates the major publication for the study
ADDITIONAL TABLES
Table 1. Glossary
Anterior nares External portion of the nostrils, which opens anteriorly into the nasal cavity and allows air inhalation
and exhalation
Axilla (pl. axillae) Also known as the armpit, underarm, or oxter; the area directly under the joint where the human arm
connects to the shoulder
Cellulitis Term commonly used to indicate non-necrotising inflammation of the skin and subcutaneous tissues,
a process usually related to acute infection that does not involve the fascia or muscles
Endogenous chromophobes A chemical group (such as an azo group) that absorbs light at a specific frequency and so imparts colour
to a molecule that originates from within an organism, tissue, or cell
Epidermis One or more layers of cells forming the outermost portion of the skin or integument
Interventions for bacterial folliculitis and boils (furuncles and carbuncles) (Protocol) 9
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Table 1. Glossary (Continued)
Gram-negative bacteria Bacteria that contain an additional outer membrane composed of phospholipids and lipopolysaccha-
rides that do not retain the crystal violet dye in the Gram stain protocol
Keratolytic Causing the horny outer layer of skin to soften and shed
Lymphadenitis Associated with the lymph nodes, which are responsible for fighting off infections of the body; refers to
the condition by which lymph nodes become inflamed, swell, and become tender during an infection
Perifollicular tissue Tissue surrounding a hair follicle; usually used to describe the histopathological appearance of the
infiltrate surrounding a hair follicle
Pathogen Any small organism, such as a virus or a bacterium, that can cause disease
Pseudomonal Of or related to the Pseudomonas species, which is a ubiquitous strictly aerobic gram-negative bacterium
with a predilection to moist environments and is a clinically significant opportunistic pathogen, often
causing nosocomial infections
Superficial dermis Middle layer of skin, deep to the epidermis and superficial to the subcutaneous layer
Cefadroxil • Adult: 1 g orally daily in a single dose or • Concurrent use of cefadroxil and
in divided doses twice a day warfarin may result in increased risk of
• Pediatric: 30 mg/kg orally once daily or bleeding
in equally divided doses every 12 hours • Concurrent use of cefadroxil and
contraceptives (combination) may result in
decreased contraceptive effectiveness
Ciprofloxacin • Adult: 500 mg orally every 12 hours for • Concurrent use of ciprofloxacin and
7 to 14 days; 400 mg IV every 12 hours for 7 insulin and oral hypoglycaemics may result in
to 14 days increased or decreased blood sugar
• Concurrent use of ciprofloxacin and
caffeine may result in increased caffeine
plasma concentrations
• Concurrent use of ciprofloxacin and
cimetidine may result in increased blood level
of ciprofloxacin
Interventions for bacterial folliculitis and boils (furuncles and carbuncles) (Protocol) 10
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Table 2. Regimens and drug-drug interactions of systemic antibiotics (Continued)
Clindamycin • Adult: 150 to 300 mg orally every 6 • Concurrent use of clindamycin and
hours, 600 to 1200 mg/d IV or IM divided kaolin may result in decreased absorption of
every 6 to 12 hours kaolin
• Pediatric: 8 to 16 mg/kg/d ORALLY • Concurrent use of clindamycin and
divided every 6 to 8 hours; 15 to 20 mg/kg/d muscle relaxants (e.g. atracurium, baclofen,
IV or IM divided every 6 to 8 hours diazepam) may result in increased frequency
and duration of respiratory paralysis
• Concurrent use of clindamycin and St
Interventions for bacterial folliculitis and boils (furuncles and carbuncles) (Protocol) 11
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Table 2. Regimens and drug-drug interactions of systemic antibiotics (Continued)
Tetracyclines • Adult: 500 mg orally twice daily or 250 • Concurrent use of tetracycline and
mg orally 4 times per day atovaquone may result in decreased
• Pediatric: (older than 8 years) 25 to 50 atovaquone levels
mg/kg orally in 4 equally divided doses • Concurrent use of tetracycline and
digoxin may result in increased toxicity of
digoxin
• Concurrent use of tetracycline and
methoxyflurane may result in increased
toxicity, polyuria, and renal failure
• Concurrent use of tetracycline and
sucralfate may result in decreased absorption
of tetracycline
• Concurrent use of tetracycline and
aluminium, bismuth, iron, or Mg2+ may
result in decreased absorption of tetracycline
• Concurrent use of tetracycline and
barbiturates or hydantoins may result in a
decreased serum half-life of tetracycline
• Concurrent use of tetracycline and
carbamazepine may result in a decreased
serum half-life of tetracycline
• Concurrent use of tetracycline and
digoxin may result in an increased serum level
of digoxin
• Concurrent use of tetracycline and
warfarin may result in increased activity of
warfarin
Interventions for bacterial folliculitis and boils (furuncles and carbuncles) (Protocol) 12
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Table 2. Regimens and drug-drug interactions of systemic antibiotics (Continued)
Linezolid • Adult: 400 to 600 mg ORALLY every 12 • Concurrent use of linezolid and
hours for 10 to 14 days adrenergic agents may result in increased risk
• Pediatric: (birth through 11 years) 10 of hypertension
mg/kg IV or ORALLY every 12 hours • Concurrent use of linezolid and
clarithromycin may result in an increased
blood concentration of linezolid
• Concurrent use of linezolid and
meperidine may result in increased risk of
serotonin syndrome
• Concurrent use of linezolid and
rasagiline may result in increased risk of
serotonin syndrome
• Concurrent use of linezolid and rifampin
may result in a decreased serum level of
linezolid
• Concurrent use of linezolid and
serotonergic drugs may result in increased risk
of serotonin syndrome
Glycopeptide (as vancomycin) Adult: 30 mg/kg/d IV in 2 divided doses or 40 • Concurrent use of vancomycin and
mg/kg/d IV in 4 divided doses aminoglycosides may result in increased
frequency of nephrotoxicity
Al: aluminium; Ca: calcium; CNS: central nervous system; Fe: iron; Mg: magnesium; NSAIDs: non-steroidal anti-inflammatory drugs;
Zn: zinc.
Interventions for bacterial folliculitis and boils (furuncles and carbuncles) (Protocol) 13
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
APPENDICES
Study ID (Surname of first author and publication year of first full report of study)
Numbers of recruitment locations At how many study sites are participants recruited for the trial?
Participants Inclusion criteria Enter the characteristics that the participants must have in this trial
Exclusion criteria Enter the characteristics that the participants cannot have if enrolled
in this trial
Interventions for bacterial folliculitis and boils (furuncles and carbuncles) (Protocol) 14
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
(Continued)
Numbers of participants randomised How many participants were randomised in this trial?
Mean age (years) Enter the mean age ± SD of participants assigned to each group
Sex (% male) Enter the percentage of male participants assigned to each group
Numbers of participants analysed Data from how many participants are analysed in this trial?
Numbers of dropouts How many randomised participants are lost to follow-up during the
study period?
Interventions Types of interventions Enter the types and methods of interventions, for example, topical
antibiotics, antiseptic agents, systemic antibiotics, phototherapy, or
surgical interventions
Names of medications or methods Enter the names of the interventions, such as the generic name of
drugs
Dosage Enter the dose and frequency for drugs. Enter the duration and
frequency for phototherapy. For surgical intervention, enter ’N/A’
CONTRIBUTIONS OF AUTHORS
CC was the contact person with the editorial base.
CC co-ordinated the contributions from co-authors and wrote the final draft of the protocol.
HL, PL, YT, and CC worked on the methods sections.
HL and CC drafted the clinical sections of the background and responded to clinical comments of the referees.
CC responded to methodology and statistics comments of the referees.
HL, PL, YT, SW, and CC contributed to writing of the protocol.
SW was the consumer co-author who checked the protocol for readability and clarity. She also ensured that the outcomes are relevant
to consumers.
CC is the guarantor of the final review.
Interventions for bacterial folliculitis and boils (furuncles and carbuncles) (Protocol) 15
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Disclaimer
This project was supported by the National Institute for Health Research, via Cochrane Infrastructure funding to the Cochrane Skin
Group. The views and opinions expressed therein are those of the review authors and do not necessarily reflect those of the Systematic
Reviews Programme, NIHR, NHS, or the Department of Health.
DECLARATIONS OF INTEREST
Ching-Chi Chi: received fees for speaking from AbbVie Taiwan, Ego Pharmaceuticals Taiwan, Janssen-Cilag Taiwan, Novartis Taiwan,
and Pfizer Taiwan.
Huang-Shen Lin: none known.
Pei-Tzu Lin: none known.
Yu-Shiun Tsai: none known.
Shu-Hui Wang: none known.
SOURCES OF SUPPORT
Internal sources
• No sources of support supplied
External sources
• The National Institute for Health Research (NIHR), UK.
The NIHR, UK, is the largest single funder of the Cochrane Skin Group.
Interventions for bacterial folliculitis and boils (furuncles and carbuncles) (Protocol) 16
Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.