p.6
Outcomes of ciNPWT vs Standard Dressings
What was the primary finding regarding the prophylactic use of ciNPWT in the trial?
It was not associated with a reduction in the rate of postoperative SSIs compared with standard dressings.
p.10
Outcomes of ciNPWT vs Standard Dressings
What interventions were compared in Sabat et al, 2016?
Standard surgical dressing (gauze and Tegaderm) vs negative pressure wound therapy (Prevena).
p.6
Bias Assessment in Clinical Research
What factors were reported incompletely across the included trials?
Preoperative hair removal, skin disinfection techniques, perioperative systemic antibiotics, closure technique, and postoperative glycemic control.
p.7
Clinical Implications of ciNPWT Use
What is recommended for minimizing the incidence of SSIs?
An institutional focus on bundled processes of care informed by surgeon and nursing input, accepted by the entire vascular care team.
p.2
Systematic Review Methodology
What were the eligibility criteria for the RCTs included in the study?
RCTs evaluating the effect of prophylactic ciNPWT and standard care on postoperative SSIs in adults with closed groin incisions for open arterial interventions.
p.7
Clinical Implications of ciNPWT Use
What should guide the decision on the routine use of ciNPWT?
Institutional and individual surgeon outcomes.
p.14
Bias Assessment in Clinical Research
What is the risk associated with selective reporting in Pleger et al, 2018?
Unclear, as no protocol was available to compare intended outcomes.
p.15
Bias Assessment in Clinical Research
What was the risk of bias for blinding of outcomes assessment in Gombert et al, 2018?
High risk, as blinding of the involved vascular surgeons was not achievable.
p.13
Outcomes of ciNPWT vs Standard Dressings
What interventions were compared in Pleger et al, 2018?
Standard surgical dressing vs negative pressure wound therapy (Prevena).
p.1
Surgical Site Infections (SSIs)
What are some best practice initiatives studied to reduce SSIs?
Standardized perioperative antibiotic administration, skin preparation, euthermia, euglycemia, and postoperative wound management.
p.4
Clinical Implications of ciNPWT Use
What has been suggested about the prophylactic use of ciNPWT in vascular surgery?
It is associated with a reduction in postoperative SSI rates.
p.5
Outcomes of ciNPWT vs Standard Dressings
What does the forest plot comparison in Fig 3 illustrate?
It compares various surgical outcomes such as surgical site infection, dehiscence, seroma, lymph leak, hematoma, need for reoperation, and readmission.
p.7
Meta-analysis of Randomized Controlled Trials (RCTs)
How did the addition of Bertges et al.'s trial affect the meta-analysis?
It led to a marginally significant amount of heterogeneity in the results.
p.7
Outcomes of ciNPWT vs Standard Dressings
What outcomes were evaluated at the wound level in the pooled analysis?
The incidence of SSIs, dehiscence, composite of seroma, lymph leak, hematoma, and the need for reoperation.
p.6
Outcomes of ciNPWT vs Standard Dressings
How did the baseline SSI rates associated with traditional dressings vary?
They appeared to vary widely across the trials.
p.10
Bias Assessment in Clinical Research
What was a noted limitation regarding patient allocation in Lee et al, 2017?
Allocation of patients with bilateral surgical sites not reported.
p.15
Bias Assessment in Clinical Research
What was unclear about allocation concealment in Gombert et al, 2018?
Concealment of allocation to the operating surgeon before and during the case was not reported.
p.13
Bias Assessment in Clinical Research
What was the risk associated with blinding of outcomes assessment in Kwon et al, 2018?
High risk because the assessor was not blinded.
p.1
Outcomes of ciNPWT vs Standard Dressings
What significant result was found regarding the use of ciNPWT?
ciNPWT was associated with a significant reduction in the rate of surgical site infections (OR, 0.39; P < .001).
p.4
Outcomes of ciNPWT vs Standard Dressings
What was the finding regarding in-hospital mortality rates in the ciNPWT group?
Mortality rates were low, with no pooled analysis performed.
p.14
Outcomes of ciNPWT vs Standard Dressings
What interventions were compared in Gombert et al, 2018?
Standard wound dressing vs negative pressure wound therapy (Prevena).
p.8
Closed Incision Negative Pressure Wound Therapy (ciNPWT)
What is the focus of the randomized clinical trial by Kwon et al. (2018)?
Evaluating negative pressure therapy to decrease vascular groin incision complications.
p.7
Meta-analysis of Randomized Controlled Trials (RCTs)
What were the main limitations identified in the meta-analysis?
The meta-analysis was limited by high risk of bias in trials, poor allocation concealment, heterogeneity in primary outcomes, variable methods for patient allocation, and inconsistent definitions of postoperative wound outcomes.
p.3
Meta-analysis of Randomized Controlled Trials (RCTs)
What types of studies were included in the final analysis?
Seven RCTs reported in peer-reviewed journals and one randomized trial with interim data.
p.12
Outcomes of ciNPWT vs Standard Dressings
What was the primary outcome measured in Kwon et al, 2018?
Incidence of clinically determined surgical site infection at 30 days after revascularization.
p.10
Outcomes of ciNPWT vs Standard Dressings
How long did the Prevena negative pressure wound therapy remain on in Lee et al, 2017?
Until either hospital discharge or postoperative day 8, whichever occurred earlier.
p.7
Outcomes of ciNPWT vs Standard Dressings
What was the conclusion regarding the use of ciNPWT for groin wounds?
A pooled analysis demonstrated a reduction in postoperative SSI rates associated with the routine use of ciNPWT.
p.13
Bias Assessment in Clinical Research
What was unclear regarding allocation concealment in Kwon et al, 2018?
Whether randomization occurred before or after closure.
p.13
Bias Assessment in Clinical Research
What was the risk associated with blinding of participants or personnel in Kwon et al, 2018?
High risk due to postoperative dressing being visible.
p.2
Bias Assessment in Clinical Research
What tool was used to evaluate the risk of bias in the studies?
The Cochrane risk of bias tool.
p.13
Outcomes of ciNPWT vs Standard Dressings
What was the primary outcome measured in Pleger et al, 2018?
Incidence of clinically determined surgical site infection at 30 days after revascularization.
p.1
Bias Assessment in Clinical Research
What was the risk of bias assessment outcome for the studies included in the meta-analysis?
High risk of bias for participant blinding in all studies, low risk for randomization and outcome reporting, and variability in other methods.
p.14
Risk Factors for SSIs in Vascular Surgery
What comorbidities were included in the participant profile in Gombert et al, 2018?
Smoking, cardiac risk factors, and metabolic disorders.
p.9
Bias Assessment in Clinical Research
What does q REML refer to?
Angle of restricted maximum likelihood.
p.8
Outcomes of ciNPWT vs Standard Dressings
What was the outcome of the study by Gombert et al. (2018) regarding closed incision negative pressure therapy?
It reduces surgical site infections in vascular surgery.
p.6
Outcomes of ciNPWT vs Standard Dressings
What were the SSI rates in the ciNPWT arm of the trial?
12%, similar to other RCTs included in the pooled analysis (6%-14%).
p.2
Surgical Site Infections (SSIs)
What is the association of ciNPWT use in high-risk patients?
It is associated with decreased rates of surgical site infections (SSIs).
p.10
Outcomes of ciNPWT vs Standard Dressings
What was the primary outcome in Lee et al, 2017?
Incidence of clinically determined surgical site infection within 30 days of revascularization.
p.13
Bias Assessment in Clinical Research
What was the allocation method for patients with bilateral surgical sites in Kwon et al, 2018?
Standard dressing on one side and NPWT on the other.
p.14
Bias Assessment in Clinical Research
What is the judgment regarding incomplete outcomes data in Pleger et al, 2018?
Low risk, as there was no evidence of loss of follow-up or exclusion except for one death.
p.12
Bias Assessment in Clinical Research
What was the issue with selective reporting in Engelhardt et al, 2018?
No protocol was available to compare intended outcomes.
p.14
Meta-analysis of Randomized Controlled Trials (RCTs)
What type of study design was used in Gombert et al, 2018?
Prospective, two-center randomized controlled trial.
p.11
Meta-analysis of Randomized Controlled Trials (RCTs)
Who were the participants in Engelhardt et al, 2018?
All patients undergoing vascular surgery with an inguinal incision.
p.4
Clinical Implications of ciNPWT Use
What factor has tempered the adoption of ciNPWT for routine use?
The increased cost of the intervention compared to standard dressings.
p.7
Bias Assessment in Clinical Research
What logistical challenge was noted regarding blinding in the trials?
No trials attempted to incorporate blinding, making it difficult to keep patients and treatment teams unaware of the intervention.
p.10
Bias Assessment in Clinical Research
What was a noted risk of bias in Sabat et al, 2016?
Randomization process not described; unclear allocation concealment.
p.6
Outcomes of ciNPWT vs Standard Dressings
What does the pooled analysis suggest about the routine use of ciNPWT on groin wounds for vascular surgery?
It will be associated with SSI rates of around 10%.
p.2
Surgical Site Infections (SSIs)
What was the overall incidence of SSI in the ciNPWT arm of the trial compared to previous trials?
It was quite similar to that from previously reported trials.
p.15
Bias Assessment in Clinical Research
What was the risk of bias for blinding of participants or personnel in Gombert et al, 2018?
High risk, as the postoperative dressing was visible to both participants and personnel.
p.15
Bias Assessment in Clinical Research
What was the risk of bias related to incomplete outcomes data in Gombert et al, 2018?
High risk, due to unspecified original allocation and reasons for exclusion for six drop-outs.
p.13
Systematic Review Methodology
What type of study design was used in Pleger et al, 2018?
Prospective, single-center randomized controlled trial.
p.4
Outcomes of ciNPWT vs Standard Dressings
What was noted about the hospital length of stay in the studies?
Only two studies reported data eligible for pooled analysis.
p.15
Outcomes of ciNPWT vs Standard Dressings
What was the primary outcome measured in Hasselmann et al, 2019?
Incidence of clinically determined surgical site infection at 90 days postoperatively.
p.8
Meta-analysis of Randomized Controlled Trials (RCTs)
What type of study did Pleger et al. (2018) conduct?
A prospective, randomized, single-institution study.
p.12
Bias Assessment in Clinical Research
What was the risk associated with allocation concealment in Engelhardt et al, 2018?
Unclear, as allocation might have been known by operating surgeons.
p.12
Bias Assessment in Clinical Research
What was the risk of performance bias in Engelhardt et al, 2018?
High risk, as postoperative dressing was visible to both participants and personnel.
p.3
Surgical Site Infections (SSIs)
What was the primary outcome measured in the studies?
Surgical site infections (SSIs).
p.5
Statistical Analysis in Clinical Trials
What do CI and REML stand for in the context of the forest plot?
CI stands for Confidence Interval; REML stands for Restricted Maximum Likelihood.
p.13
Risk Factors for SSIs in Vascular Surgery
What were the known main risk factors for wound healing in Pleger et al, 2018?
Age > 50 years, diabetes mellitus, renal insufficiency, malnutrition, obesity, COPD.
p.1
Risk Factors for SSIs in Vascular Surgery
What are some identified risk factors for the development of SSIs in vascular surgery?
Obesity, female sex, reoperative surgery, infrain- guinal bypass, and malnutrition.
p.8
Meta-analysis of Randomized Controlled Trials (RCTs)
What is the main finding of the meta-analysis by Antoniou et al. (2019)?
Prophylactic negative pressure therapy reduces complications for groin wounds in vascular surgery.
p.3
Bias Assessment in Clinical Research
What tool was used to evaluate the risk of bias?
The Cochrane risk of bias tool.
p.7
Surgical Site Infections (SSIs)
What factors contribute to the development of postoperative SSIs?
A complex interplay of patient, physician, procedural, and institutional factors.
p.13
Bias Assessment in Clinical Research
What method was used for random sequence generation in Kwon et al, 2018?
A coin toss was used for randomization.
p.12
Risk Factors for SSIs in Vascular Surgery
What high-risk features were stratified in Kwon et al, 2018?
BMI > 30 kg/m², significant pannus, reoperative groin surgery, placement of prosthetic vascular graft, poor nutrition, immunosuppression, and poorly controlled diabetes.
p.2
Statistical Analysis in Clinical Trials
What statistical method was used to analyze the data?
Random effects meta-analyses using restricted maximum likelihood estimation.
p.11
Bias Assessment in Clinical Research
How was the long-term assessment of outcomes conducted in Lee et al, 2017?
It was blinded, conducted by a wound specialist nurse unaware of treatment groups.
p.2
Meta-analysis of Randomized Controlled Trials (RCTs)
What was the total number of randomized control trials included in the analysis?
8 randomized control trials.
p.15
Bias Assessment in Clinical Research
What was the risk of other bias in Gombert et al, 2018?
High risk, as the study was funded by the producers of the investigated intervention, indicating a conflict of interest.
p.1
Clinical Implications of ciNPWT Use
What potential mechanisms might explain the beneficial effects of ciNPWT?
Maintenance of a sterile environment, improvement in tissue perfusion, reduction in site edema, and reduction in tension across the incision.
p.6
Bias Assessment in Clinical Research
What was a significant factor contributing to the heterogeneity among control arms in the trials?
Variable high-risk clinical features in the inclusion criteria of several trials.
p.5
Outcomes of ciNPWT vs Standard Dressings
What does 'B' refer to in the forest plot?
Surgical site dehiscence.
p.2
Outcomes of ciNPWT vs Standard Dressings
What was the outcome of the large multicenter RCT regarding prophylactic ciNPWT?
It did not identify a benefit from prophylactic ciNPWT as demonstrated by other trials.
p.12
Meta-analysis of Randomized Controlled Trials (RCTs)
What type of trial was conducted in Kwon et al, 2018?
Prospective, single-center randomized controlled trial.
p.14
Bias Assessment in Clinical Research
What is the judgment regarding allocation concealment in Pleger et al, 2018?
Unclear, as the allocation concealment process is not described.
p.12
Bias Assessment in Clinical Research
What was a limitation noted in Engelhardt et al, 2018 regarding outcome assessment?
Assessor blinding was not described.
p.1
Meta-analysis of Randomized Controlled Trials (RCTs)
How many RCTs were included in the meta-analysis and what was the total number of incisions?
Eight RCTs with a total of 1125 incisions.
p.4
Outcomes of ciNPWT vs Standard Dressings
What was the conclusion regarding the need for reoperation with ciNPWT?
There was no reduction in the need for reoperation (OR, 0.68).
p.14
Meta-analysis of Randomized Controlled Trials (RCTs)
What was the primary outcome measured in Gombert et al, 2018?
Incidence of clinically determined surgical site infection at 30 days postoperatively.
p.11
Outcomes of ciNPWT vs Standard Dressings
What were the two interventions compared in Engelhardt et al, 2018?
Standard surgical dressing vs Prevena negative pressure wound therapy.
p.9
Bias Assessment in Clinical Research
What is the focus of the study by Boll et al. published in June 2022?
Risk of publication bias.
p.8
Systematic Review Methodology
What did the systematic review by Gombert et al. (2020) compare?
Closed incision management versus standard of care dressings over closed vascular groin incisions.
p.8
Systematic Review Methodology
What does the PRISMA statement relate to?
Preferred reporting items for systematic reviews and meta-analyses.
p.10
Risk Factors for SSIs in Vascular Surgery
What were the risk factors for surgical site infections in Lee et al, 2017?
Obesity (BMI > 30 kg/m²), previous femoral artery exposure, or presence of ischemic tissue loss.
p.3
Bias Assessment in Clinical Research
What was the performance bias risk for all eight included studies?
High risk, as blinding participants to treatment was not possible.
p.15
Bias Assessment in Clinical Research
What was the risk of bias regarding random sequence generation in Gombert et al, 2018?
Low risk, as the randomization sequence was computer generated using the random allocation rule.
p.2
Outcomes of ciNPWT vs Standard Dressings
What was the primary outcome evaluated in the study?
The presence of postoperative surgical site infections (SSIs).
p.1
Secondary Outcomes in Surgical Studies
What were the primary and secondary outcomes assessed in the meta-analysis?
Primary outcome: incidence of postoperative surgical site infections (SSIs). Secondary outcomes: wound dehiscence, seroma, lymph leakage, hematoma, need for reoperation, in-hospital mortality, readmission, and hospital length of stay.
p.2
Systematic Review Methodology
What were some reasons for excluding articles from the analysis?
Meta-analyses, retrospective cases, review articles, and studies without groin wound outcomes.
p.15
Systematic Review Methodology
What type of study was conducted by Hasselmann et al, 2019?
A prospective, single-center randomized control trial.
p.11
Outcomes of ciNPWT vs Standard Dressings
What was the primary outcome measured in Engelhardt et al, 2018?
Incidence of clinically determined surgical site infection at 5 days and 6 weeks after revascularization.
p.10
Meta-analysis of Randomized Controlled Trials (RCTs)
What type of study design was used in Sabat et al, 2016?
Prospective randomized controlled trial.
p.12
Bias Assessment in Clinical Research
What was the random sequence generation method used in Engelhardt et al, 2018?
Sealed randomization envelopes provided by an external institution.
p.5
Outcomes of ciNPWT vs Standard Dressings
What outcome is indicated by 'C' in the forest plot?
Surgical site seroma, lymph leak, or hematoma.
p.14
Bias Assessment in Clinical Research
What is the risk associated with random sequence generation in Pleger et al, 2018?
Unclear, as the randomization process is not described.
p.11
Bias Assessment in Clinical Research
What software was used for random sequence generation in Lee et al, 2017?
Internet-based block randomization software (sealedenvelop.com).
p.14
Bias Assessment in Clinical Research
What is the risk level for blinding of participants or personnel in Pleger et al, 2018?
High risk, as postoperative dressing was visible to both participants and personnel.
p.1
Meta-analysis of Randomized Controlled Trials (RCTs)
What was the objective of the meta-analysis conducted by the New England Society for Vascular Surgery?
To evaluate the efficacy of closed incision negative pressure wound therapy (ciNPWT) on vascular surgery groin wounds after a previous study reported no benefits.
p.14
Bias Assessment in Clinical Research
What conflicting statements were made regarding Acelity in Pleger et al, 2018?
The study was claimed to be conducted independently, yet authors acknowledged assistance from Acelity.
p.11
Meta-analysis of Randomized Controlled Trials (RCTs)
What type of study design was used in Engelhardt et al, 2018?
Prospective, single-center, randomized controlled trial.
p.15
Systematic Review Methodology
Who were the participants in the study by Hasselmann et al, 2019?
All adult patients scheduled for elective vascular surgery with inguinal incisions.
p.10
Outcomes of ciNPWT vs Standard Dressings
What was the primary outcome measured in Sabat et al, 2016?
Incidence of clinically determined surgical site infection by 4 months after revascularization.
p.8
Bias Assessment in Clinical Research
What is the purpose of the RoB 2 tool developed by Sterne et al. (2019)?
Assessing risk of bias in randomized trials.
p.8
Surgical Site Infections (SSIs)
What does the ASEPSIS scoring method evaluate?
Postoperative wound infections for use in clinical trials of antibiotic prophylaxis.
p.6
Secondary Outcomes in Surgical Studies
What secondary outcomes showed no significant differences between ciNPWT and traditional dressings?
Wound dehiscence, seroma, lymph leak, hematoma, need for reoperation, and readmission.
p.12
Outcomes of ciNPWT vs Standard Dressings
What were the interventions compared in Kwon et al, 2018?
Standard surgical dressing vs negative pressure wound therapy.
p.3
Secondary Outcomes in Surgical Studies
What secondary outcomes were measured in the study by Lee et al, 2017?
Reoperation, length of stay (LOS), readmission, mortality at 90 days.
p.15
Bias Assessment in Clinical Research
What was the issue with selective reporting in Gombert et al, 2018?
The clinical trial protocol listed 'prolongation of ambulant treatment' as a secondary outcome, but it was not described in the final report.
p.13
Bias Assessment in Clinical Research
What was reported regarding other bias in Kwon et al, 2018?
Authors reported nothing to disclose regarding support.
p.15
Outcomes of ciNPWT vs Standard Dressings
What were the interventions compared in Hasselmann et al, 2019?
Standard surgical dressing vs PICO negative pressure wound therapy.
