Table 7.

Studies that used both clinical and microbial indicators to diagnose infection in chronic leg ulcers

Author(s), year	Study design & aims	Total CLUs	Clinical indicators used	Microbial indicators used
Alcaraz & Kelly, 200271	Case study To describe the effect of honey dressing in management of an infected VLU	1 infected VLU	Sloughy, painful, and very wet with green exudate	Wound swab, culture: heavy growth of Haemolytic streptococci group G, Proteus spp, and moderate growth of anaerobes
Bhat et al,201434	Single arm before‐after clinical trial design To test the effectiveness of the Panchavalkala cream on chronic non‐healing wounds that were infected	50 patients with infected chronic non‐healing wounds	Slough, swelling, redness, discharge, Malodour, pain, and tenderness	Punch biopsy 105–106 dilutions: mildly infected 107–108 dilutions: moderate infected >108 dilutions: Severe infected
Danielsen et al, 199849	Case study	1 infected VLU	Ulcer enlargement, no cellulitis	Wound exudate cultured found Pseudomonas aeruginosa exotoxin
Eisenstein, 200872 USA	Case study	1 infected VLU	Extreme pain and swelling in the left ankle	MRSA and Enterobacter spp.
Flock, Gibbs & Sykes, 200067	Case study	1 infected VLU	Ulcer related pain, foul odour, mucopurulent discharge, and oedema	Wound swab & culture: mixed flora and anaerobes
Forlee, Rossington, & Searle, 201453 South Africa	A prospective, open, multi‐centre observational study	14 VLUs: 12 clinically infected	Wound static or deteriorating, Increased exudate/secretion levels, Increased pain, Increased temperature around the wound, Discolouration of granulation tissue, Friable granulation, Tissue necrosis, Local erythema, Oedema, Purulent drainage, and Odour (Cutting & Harding, 2004)	Positive tissue biopsy results at the initial assessment ≥104 CFU/g
Gerry et al, 200792 USA	Case study	1 infected VLU	Wound failed to heal, extensive induration, foul‐smell, and wept turbid fluid	Culture of the wound identified Stenotrophomonas
Graham, 201459 USA	A pilot observational study To assess the viability of a MRSA wound healing protocol intended for use in multiple settings	40 patients with MRSA‐infected lower extremity wounds: 10 VLUs	Erythema, oedema, heat, pain, and purulent exudate, odour, serous exudate, delayed healing, friable granulation tissue, discoloured granulation tissue, pocketing of the wound base, and wound breakdown	Wound swab culture positive for MRSA
Griffiths, Fernandez &Ussia, 200115 Australia	A double‐blind randomised controlled trial	35 patients with 49 wounds: 5 VLUs	Using Cutting's criteria: purulent discharge	Wound swab culture: mixed growth of Staphylococcus species and Proteus species
Imbernon et al, 201693 Spain	Case study	An infected VLU in a patient with diabetes	Disabling and highly painful leg, erythematous edges, seropurulent exudate with haemorrhagic scabs	Culture positive for Methicillin Resistance Staphylococcus aureus
Isbary et al, 201017 Germany	A prospective randomised controlled phase II trial To examine the safety and efficiency of 5 minutes daily cold atmospheric argon plasma to decrease bacterial load	38 chronic infected wounds in 36 patients: mostly CLUs	Did not clearly mention Had at least one chronic infected skin wound large enough for the plasma treatment and a control area of 3 cm2 29/36 patients received systemic antibiotics	Wound swab Semi‐quantitative assessment Bacterial types were detected from the wounds from culture
Isbary et al, 201216 Germany	A prospective randomised controlled phase II trial Investigated a 2‐min daily plasma treatment with MicroPlaSter alpha device versus MicroPlaSter beta device	24 patients with chronic infected wounds: 17 VLUs, 4 ALUs, 2 MLUs	Did not clearly mention Had at least one chronic infected skin wound large enough for the plasma treatment and a control area of 3 cm2 22 patients received systemic antibiotics	Wound swab culture to identify bacteria present in the wounds
Kordestani et al, 200818 Iran	A randomised controlled trial study To compare the wound healing rate and incidence of infection in wounds treated with either a bioactive dressing or the control dressing	54 patients with either diabetic foot ulcers, pressure ulcers, or leg ulcers	Did not mention/describe but needed to show clinical signs of infection	Wound swab Infected if the bacterial bioburden >105 CFU/mL, or if beta‐haemolytic streptococcus was present then 103 CFU/mL was the indicator of infection
Lantis & Gendics, 201122 United Kingdom	A prospective cohort study To determine the in vivo effect of a sustained‐release silver sulphadiazine powder foam dressing—Allevyn Ag Non‐Adhesive on the bacterial burden of VLUs	24 patients with VLUs	≥1 clinical signs of infection: oedema, malodour, local/peri‐wound erythema, spontaneous pain between dressing changes, increased exudate, discolouration of granulation tissue, increased temperature at wound, non‐progression of wound closure, and purulent exudate or friable granulation tissue	Had a bioburden of ≥105 CFU/g of tissue
Raad et al, 201081 USA	A retrospective review of 5 cases To determine the in vivo effect of a sustained‐release silver sulphadiazine powder foam dressing on the bacterial burden of VLUs	5 patients with VLUs	Ulcers greater than 200 cm2	Biopsy, Quantitative cultures: bacterial load ≥105 CFU/g of tissue Two patients had multi‐drug‐resistant pseudomonas, three with MRSA. All five had coliforms present as well
Lisle, 200260 England	Case study		Hot to the touch, red, painful (pain rated at 8 out of 10 by Mrs R) and with offensive smelling exudate	Swabs cultured positive: MRSA, β‐haemolytic streptococci and mixed enteric flora.
Nagoba et al, 200868 India	Two cases		Case 1: unhealthy granulation tissue and slough, delayed healing despite treatment Case 2: the ulcer had a very bad look with abundant slough and active pus discharge	The culture of the exudates yielded S. aureus – Case 1 A culture of the exudates yielded S. aureus and Escherichia coli – case 2
Martin et al, 200870 Spain	Case study	1 infected leg ulcer	Painful ulcers in both legs, which carried a chronic lymphoedema background increased pain and exudation	Mixed flora—consisting of multi‐resistant bacterial organisms—was isolated from both legs. In addition, Vibrio metschnikovii was isolated from the left lower limb
Rossi & Wertzberger, 199661 Italia	Case study	1 CLU	The wound: 14 × 7 cm, covered with slough, malodorous, warm to touch, erythematous and oedematous to the knee	Positive culture Swabs
Salavastru et al, 201266 Romania	A retrospective observational study using the hospital's electronic database	420 patients with VLUs	Increased exudate production, foul odour, rapid extension of the ulcerated area, hyperpyrexia, and cellulitis	Positive bacteriological swab: S. aureus – present in 55 patients (26.3%), Enterobacter spp. (17.2%), Proteus spp., E. coli and P. aeruginosa, two cases of Enterococcus spp. and one case of Candida albicans
Sari et al, 200962 Turkey	Prospective pre‐post evaluation study To evaluate the efficacy of a vacuum‐assisted closure ‐V.A.C. Therapy device in the comparative management of clean and infected wounds	46 patients presented 52 wounds: 35 lower extremity ulcers 31 infected wounds	The presence of exudation and peri‐lesional erythema were considered signs of inflammation or infection Covered with necrotic tissue, purulent discharge	Positive wound culture. The most common pathogen isolated in wound cultures was P. aeruginosa followed by S. aureus
Schiffer et al, 201586 Austria	Prospective cohort study	95 patients clinically diagnosed with infection: 10 CLUs	Patients were clinically diagnosed with infection by physicians, but did not describe clinical signs	Swab microbiology analysis – did not describe standards used
Sibbald et al, 200140 Canada	An uncontrolled, open‐label prospective study, single centre, four arm study To evaluate the clinical effect of the ionised nanocrystalline silver dressing on a variety of chronic wounds	29 patients: 6 VLUs	Non‐healing, devitalised loose yellow debris and necrosis in the base of the ulcer, increased or a bright red granulation tissue that friable and exuberant, bridging of non‐viable epidermis, increased exudate, and exudate becomes purulent	Wound swab – semi‐quantitative ≥106 CFU/g tissue
Sibbald, Coutts & Woo, 201138 Canada	A multi‐centre, prospective, double‐blind, pilot, randomised controlled clinical trial To evaluate the effectiveness of a PHMB foam dressing compared with a similar non‐antimicrobial foam for the treatment of superficial bacterial burden, wound‐associated pain, and reduction in wound size	45 subjects with leg (n = 23) and foot (n = 22) ulcers	Peri‐wound infection: the presence ≥3 criteria from the STONEES: Size, Temperature difference by 3‐ F by infrared thermometry, O—probe/exposed bone, new satellite area breakdown, erythema and oedema, exudate smell, non‐healing, exudate, red friable granulation debris on the surface Smell	Wound infection was equated to ≥105 colony‐forming units per millilitre
Thai et al, 200263 USA	Case study describes the effects of ultraviolet light C on wound bioburden and closure in three people with chronic ulcers infected with methicillin‐resistant S. aureus	3 chronic wounds: 1 mixed led ulcer	Loosely adherent slough, copious amounts of purulent yellow exudate, significant erythema surrounded the wounds, extreme pain limiting patient's mobility and significant sleep disturbances.	Semi‐quantitative bacterial cultures Presence of three types of bacteria: MRSA, P. aeruginosa and S. aureus

ALU, arterial leg ulcer; CFU, colony‐forming units; CLUs, chronic leg ulcers; MLU, mixed leg ulcers; MRSA, methicillin‐resistant Staphylococcus aureus; PHMB, polyhexamethylene biguanide; VLUs, venous leg ulcers.