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Table 1 Eligibility criteria for the systematic review

From: Plus Sutures for preventing surgical site infection: a systematic review of clinical outcomes with economic and environmental models

 

Inclusion Criteria

Exclusion Criteria

Population

• Studies in adults and children in whom Plus Sutures (including Stratafix Plus) are an appropriate option

• Studies assessing sutures for wound closure following an invasive surgical procedure

Population subgroups of interest are as follows:

• Adults

• Children

• Clean wound procedures

• Non-clean wound procedures

• Participants with a known allergy to triclosan or contraindicated for the use of Plus Sutures

• Studies assessing sutures for wound closure in settings other than invasive surgery

Intervention

Plus Sutures (Ethicon, Johnson & Johnson Medical Ltd):

• PDS Plus Antibacterial (polydioxanone) Suture

• MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture

• Coated VICRYL Plus Antibacterial (polyglactin 910) Suture

• STRATAFIX Symmetric PDS Plus Knotless Tissue Control Device

• STRATAFIX Spiral PDS Plus Knotless Tissue Control Device

• STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device

Studies assessing “triclosan-coated sutures” that do not refer to a brand name, will also be eligible

• Studies of any sutures other than the named eligible technologies

• Studies of mixed eligible and ineligible interventions where results are not disaggregated according to suture variety or variant, i.e. studies where some patients in the intervention group receive one or more of the named Plus Sutures, and the remaining patients in the intervention group receive an ineligible intervention

Comparators

Standard of care, i.e.:

• Sutures without any antibacterial coating

• Other sutures with an antibacterial coating, including other types of Plus Suture

Outcomes

• Incidence of SSI

• Antibiotic use for SSI

• Hospital stay related to SSI

◦ Length of post-operative stay in hospital relating to SSI

◦ Rate of readmission related to SSI

• Severity of SSI, as reported by study authors, including ASEPSIS (additional treatment, serous discharge, erythema, purulent exudate, separation of tissues, isolation of bacteria, duration of stay as an inpatient) wound score

• Device-related adverse events

Outcomes added to the scope at a later date were not specified in the protocol but were summarised with a narrative synthesis from the studies included based on the criteria detailed in this table

Any other outcomes

Study design

• RCTs of any design

Any studies other than RCTs, including intraindividual trials

Limits

• Full text documents or clinical trial records containing results for at least one outcome of interest to this review

• Records of ongoing trials (to be listed for information rather than data extracted)

• Otherwise relevant clinical trial records, detailing completed trials for which no results are available (to be listed in the section for relevant unpublished data rather than data extracted)

• Only studies with a publication date of 2000 and onwards

• English language publications

• Full text publications of studies with a publication date of 1999 or earlier

• Clinical trials with a completion date of 1999 or earlier

• Studies published in languages other than English

  1. RCT randomised controlled trial, SSI surgical site infection