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Non-inferiority trial of 85 venous ulcer patients finds heel-free compression bandaging maintains therapeutic pressure and reduces ankle edema

International wound journal (PubMed)Oct 1, 2026

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Brief summary

A randomized controlled non-inferiority trial of 85 evaluable adults with open venous leg ulcers found that heel-free compression bandaging was non-inferior to traditional heel-wrapped bandaging for sustaining therapeutic interface pressure at 48 hours while achieving a 1.7 cm greater reduction in ankle circumference.

What NurseJet pulled from the source

Compression therapy remains the cornerstone of venous leg ulcer (VLU) management, but standard bandaging that covers the heel frequently causes excessive bulk, restricted ankle mobility, pain over bony prominences, and difficulty wearing footwear, leading to patient non-adherence. In a randomized, controlled, parallel-group non-inferiority trial conducted at a French university hospital (ClinicalTrials.gov NCT04046120), adults with open venous leg ulcers (CEAP C6) were randomized to receive either heel-free compression bandaging or standard heel-wrapped bandaging for 4 to 6 weeks. Of 102 randomized patients, 85 completed per-protocol evaluation. The primary endpoint was sub-bandage interface pressure measured 48 hours following the final bandage application. At visit 3, mean interface pressure was 30.1 mmHg in the heel-free group versus 28.4 mmHg in the heel-wrapped group (mean difference 1.7 mmHg; 95% CI: -1.3 to 4.6 mmHg), successfully fulfilling the prespecified non-inferiority criterion. After adjusting for baseline circumference and sex, ankle circumference was 1.7 cm lower in the heel-free group (95% CI: -3.35 to 0.04 cm). Among 48 participants who experienced both bandaging techniques during care, 47.9% (23/48) explicitly preferred the heel-free application.

Why this matters for nurses

Bedside and wound clinic nurses frequently encounter patients who remove or loosen multi-layer compression wraps because heel bulk prevents them from wearing normal shoes or causes friction over the Achilles tendon. Confirming that heel-free bandaging maintains non-inferior therapeutic pressure and controls edema gives nurses an evidence-supported technique to improve patient comfort, footwear fit, and bandaging adherence when the ulcer is not located on the heel.

Bedside takeaway

An RCT of 85 venous leg ulcer patients found heel-free compression was non-inferior for 48-hour interface pressure (30.1 vs. 28.4 mmHg) and cut ankle circumference by 1.7 cm.

Key takeaways

Non-inferiority trial evaluated 85 per-protocol adult patients with open venous leg ulcers (CEAP C6) treated for 4–6 weeks.
Heel-free bandaging was non-inferior to traditional heel-wrapped bandaging for interface pressure at 48 hours post-application (30.1 vs. 28.4 mmHg, difference 1.7 mmHg, 95% CI: -1.3 to 4.6).
Ankle circumference showed a 1.7 cm greater reduction in the heel-free group after baseline and sex adjustment (95% CI: -3.35 to 0.04).
Nearly half (47.9%) of patients with exposure to both methods reported a preference for heel-free bandaging.
Leaving the heel uncovered preserves therapeutic sub-bandage pressure without compromising distal edema control.

Practice implications

Consider heel-free compression bandaging for patients with venous leg ulcers located on the calf or supramalleolar regions when standard heel coverage impairs shoe fit or patient compliance. Ensure consistent graduated tension is applied from the base of the toes upwards, inspect the ankle and foot for pressure lines or localized edema, and verify that the ulcer margin does not involve the uncovered heel area before selecting this technique.

Limitations & cautions

Single-center trial in France; per-protocol analysis included 85 of 102 randomized patients; primary outcome focused on 48-hour interface pressure and edema rather than complete ulcer healing rates or time-to-closure.
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Citations

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International wound journal (PubMed)

International wound journal (PubMed). Heel-Free Compression Bandaging for Venous Leg Ulcers: A Non-Inferiority Trial of Interface Pressure.

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https://pubmed.ncbi.nlm.nih.gov/42851136/

Professional education only

This summary does not replace clinical judgment, facility policy, provider orders, or official guidelines. Verify practice changes against the original source and local protocol.

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Nursing in critical care (PubMed)Nov 1, 2026Research Article

A pragmatic randomized controlled trial in a neonatal intensive care unit found that using the Tomazoni anatomical measurement method for PICC insertion achieved central tip placement in 77.8% of procedures compared with 17.9% using traditional measurement, reducing catheter withdrawal requirements by 81%.

Peds Med-SurgAI summaryReview source

Research ArticleResearchQuality ImprovementAI summary · original source linked below

Accurate peripherally inserted central catheter (PICC) tip placement in neonates is vital for delivering hyperosmolar parenteral nutrition and inotropes while avoiding cardiac tamponade, extravasation, and thrombosis, yet traditional landmark measurement methods frequently result in catheter tip malposition. In a pragmatic, parallel-group randomized clinical trial with stratified block randomization conducted in a Brazilian neonatal intensive care unit (ReBEC RBR-55zwb45) between June 2024 and April 2025, 62 neonatal PICC procedures were randomized, yielding 55 evaluable procedures (27 experimental, 28 control). The experimental group utilized the Tomazoni measurement method to estimate insertion length prior to venipuncture, while the control group used the standard traditional landmark technique. Accurate central tip positioning was confirmed radiographically in 21 of 27 procedures (77.8%) in the Tomazoni group versus only 5 of 28 (17.9%) in the control group (p < 0.001). PICC insertions guided by the Tomazoni method were 4.36 times more likely to achieve central placement (relative risk [RR]: 4.36; 95% CI: 1.91–9.88). Furthermore, post-insertion catheter withdrawal due to over-insertion was required in only 11.1% (3/27) of the Tomazoni cohort compared to 57.1% (16/28) of the control cohort (p = 0.001; RR: 0.19; 95% CI: 0.06–0.59).

Key takeaways

Pragmatic RCT in a NICU analyzed 55 evaluable PICC insertions comparing the Tomazoni measurement method (n = 27) with traditional measurement (n = 28).
Tomazoni measurement achieved accurate central tip positioning in 77.8% (21/27) versus 17.9% (5/28) with standard measurement (p < 0.001).
Procedures using the Tomazoni method were 4.36 times more likely to achieve optimal central tip placement (RR: 4.36, 95% CI: 1.91–9.88).
Need for subsequent catheter withdrawal dropped from 57.1% to 11.1% (RR: 0.19, 95% CI: 0.06–0.59, p = 0.001).
The technique provides a low-cost, reproducible measurement framework that minimizes sterile field disruption and post-procedure catheter manipulation.

Why this matters on shift

Neonatal nurses and vascular access specialists placing PICCs in premature and critically ill infants face significant risks when catheter tips are positioned either intracardiac or peripheral. Repeated catheter manipulation and sterile dressing removal to adjust catheter depth introduce substantial infection and extravasation hazards. Utilizing an anatomical measurement formula that quadruples first-pass central tip accuracy substantially enhances neonatal patient safety.

Bedside takeaway

An RCT of 55 neonatal PICC insertions found the Tomazoni measurement method quadrupled central tip positioning (77.8% vs. 17.9%) and cut catheter withdrawal needs by 81%.

Nursing implications

Incorporate validated anatomical measurement strategies like the Tomazoni technique when measuring neonatal limb landmarks before catheter insertion. Ensure post-placement confirmatory radiographs are verified before infusing vesicants or hypertonic solutions, and recognize that optimizing initial insertion measurement markedly reduces subsequent sterile dressing disruptions and catheter adjustments.

Limitations & cautions

Single-center trial in one NICU in Brazil; sample size of 55 evaluable procedures; did not evaluate long-term catheter longevity, mechanical occlusion, or catheter-related bloodstream infection rates.
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Citations · exact source links

Nursing in critical care (PubMed). Effectiveness of Tomazoni Measurement Method for Central Catheter Tip Positioning in Neonates: A Randomised Controlled Trial.

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Medicina (Kaunas, Lithuania) (PubMed)Sep 10, 2026Research Article

A randomized superiority trial of 204 adult emergency department patients found no significant difference in patient-reported pain, nurse-assessed procedural difficulty, or first-attempt insertion success between 18-gauge and 20-gauge peripheral catheters in patients at low-to-moderate risk of difficult access.

Emergency Med-SurgAI summaryReview source

Research ArticleResearchWorkflowAI summary · original source linked below

Clinicians often default to smaller 20-gauge short peripheral catheters (SPCs) under the assumption that wider 18-gauge catheters cause greater pain and are harder to place. In a single-center, parallel-group superiority randomized controlled trial (ClinicalTrials.gov NCT07629427), 204 adult emergency department patients with Adult Difficult Intravenous Access (A-DIVA) scores of 0 to 3 (low-to-moderate difficulty) were randomized 1:1 to receive either an 18-gauge (n = 102) or a 20-gauge (n = 102) SPC. Patients wore goggles until catheter dressing to ensure blinding, and the data analyst was also blinded. Co-primary outcomes were patient-reported pain and nurse-reported procedural difficulty on 100 mm visual analog scales immediately following the first attempt. The trial was powered to detect a 13 mm minimum clinically important difference in pain. Median insertion pain was 32.5 mm in the 18-gauge group versus 30.5 mm in the 20-gauge group (median difference 1.0 mm, 95% CI: -4 to 6 mm; p = 0.65). Median procedural difficulty was 12.0 mm versus 15.0 mm (median difference -1.0 mm, 95% CI: -4 to 1 mm; p = 0.28). First-attempt insertion success was 92.2% in the 18-gauge group and 90.2% in the 20-gauge group (absolute risk difference 2.0 percentage points, 95% CI: -5.8 to 9.7; p = 0.62). No prespecified subgroups showed significant treatment interactions.

Key takeaways

Randomized trial enrolled 204 adult ED patients (102 in 18G group, 102 in 20G group) with low-to-moderate difficult access (A-DIVA score 0–3).
Patient-reported pain immediately after insertion was similar between 18G and 20G catheters (median 32.5 mm vs. 30.5 mm, p = 0.65).
Nurse-assessed procedural difficulty on a 100 mm VAS did not differ between gauges (median 12.0 mm for 18G vs. 15.0 mm for 20G, p = 0.28).
First-attempt placement success was 92.2% for 18-gauge and 90.2% for 20-gauge catheters (p = 0.62).
Confidence intervals for pain difference lay well within the 13 mm prespecified threshold for clinical importance.

Why this matters on shift

Emergency and acute-care nurses frequently balance catheter diameter against patient comfort when establishing vascular access. When patients anticipate rapid volume resuscitation, blood product administration, or computed tomography contrast requiring high flow rates, nurses can confidently select an 18-gauge catheter knowing that in non-difficult access veins, it does not inflict clinically meaningful additional pain or lower placement success compared to a 20-gauge.

Bedside takeaway

An RCT of 204 adult ED patients found 18G and 20G IV catheters produced comparable insertion pain (32.5 vs. 30.5 mm) and first-attempt success (92.2% vs. 90.2%).

Nursing implications

Select peripheral catheter gauge based on intended infusate viscosity, required infusion rates, and diagnostic imaging protocols rather than reflexively choosing smaller bores for pain avoidance. In adult patients without severe difficult access history, explain to patients that larger 18-gauge catheters do not produce greater discomfort, while verifying vein caliber and trajectory prior to venipuncture in accordance with hospital vascular access policies.

Limitations & cautions

Single-center design; restricted to adult patients with low-to-moderate difficult access (A-DIVA score 0 to 3); designed as a superiority rather than equivalence trial; catheter dwell complications and phlebitis beyond immediate insertion were not evaluated.
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Citations · exact source links

Medicina (Kaunas, Lithuania) (PubMed). A Comparison of 18-Gauge and 20-Gauge Short Peripheral Catheters in Terms of Pain and Procedural Difficulty: A Randomized Controlled Trial in the Emergency Department.

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Journal of critical care (PubMed)Aug 13, 2026Systematic Review

A systematic review and meta-analysis of seven randomized controlled trials encompassing approximately 9,127 critically ill patients found that pantoprazole stress-ulcer prophylaxis reduced clinically important gastrointestinal bleeding by 47% compared to placebo without altering all-cause mortality or increasing risks of ventilator-associated pneumonia or Clostridioides difficile infection.

Med-Surg ICUAI summaryReview source

Systematic ReviewResearchMedication SafetyAI summary · original source linked below

Stress-related mucosal damage represents a common risk among critically ill patients undergoing mechanical ventilation or experiencing coagulopathy, yet the balance between bleeding prevention and potential adverse infectious risks associated with gastric acid suppression has remained debated. Following PRISMA-2020 guidelines, this systematic review and meta-analysis synthesized evidence from seven randomized controlled trials (RCTs) identified across PubMed, Scopus, and Cochrane CENTRAL, evaluating approximately 9,127 adult and pediatric intensive care unit (ICU) patients (4,575 assigned to pantoprazole and 4,552 assigned to placebo). Pantoprazole administration significantly reduced the primary outcome of clinically important gastrointestinal bleeding (relative risk [RR]: 0.53; 95% CI: 0.29–0.94; p = 0.03). However, pantoprazole did not alter all-cause mortality (RR ≈ 0.99; 95% CI: 0.92–1.05; p = 0.68). In secondary safety assessments, infection rates were comparable between groups, with no statistically significant increase in ventilator-associated pneumonia (RR = 0.99; p = 0.78) or Clostridioides difficile infection (RR = 1.11; p = 0.73). Robustness was confirmed across sensitivity analyses.

Key takeaways

Meta-analysis synthesized 7 randomized controlled trials encompassing ~9,127 ICU patients (4,575 receiving pantoprazole, 4,552 receiving placebo).
Pantoprazole prophylaxis reduced clinically important GI bleeding by 47% (RR 0.53, 95% CI: 0.29–0.94, p = 0.03).
All-cause mortality was unaffected by prophylaxis (RR 0.99, 95% CI: 0.92–1.05, p = 0.68).
Risk of ventilator-associated pneumonia was not increased in pantoprazole-treated patients (RR 0.99, p = 0.78).
Incidence of Clostridioides difficile infection showed no significant difference compared to placebo (RR 1.11, p = 0.73).

Why this matters on shift

Critical care and acute care nurses administer proton pump inhibitors daily to prevent gastrointestinal bleeding in ventilated and severely ill patients, but frequent clinical concerns exist regarding secondary nosocomial pneumonia and C. diff colitis from altered gastric microbiome. Clarifying that pantoprazole provides robust gastroprotection without elevated pneumonia or C. diff risk reinforces safe, targeted medication administration guidelines.

Bedside takeaway

A meta-analysis of ~9,127 ICU patients showed pantoprazole halved clinically important GI bleeding (RR 0.53) without increasing mortality, VAP, or C. diff infection.

Nursing implications

Confirm that ICU patients receiving acid-suppressive prophylaxis meet established risk criteria (e.g., invasive mechanical ventilation >= 48 hours or coagulopathy). Monitor patients for signs of occult and overt gastrointestinal bleeding, inspect stools and gastric aspirates, and re-evaluate the ongoing necessity of proton pump inhibitor therapy as patients transition toward enteral nutrition and clinical recovery in collaboration with the clinical pharmacist and care team.

Limitations & cautions

Included heterogeneous ICU patient populations spanning both adult and pediatric cohorts; variations in specific pantoprazole dosages and administration routes across included trials; long-term post-ICU outpatient outcomes not assessed.
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Citations · exact source links

Journal of critical care (PubMed). Efficacy and safety of pantoprazole for stress-ulcer prophylaxis in critically ill patients: A systematic review and Meta-analysis of randomized controlled trials.

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Key takeaways

Practice implications

Limitations & cautions

Exact source links

More updates for this clinical area

Randomized trial of 55 neonatal PICC insertions finds Tomazoni measurement method quadruples central tip placement accuracy

Randomized trial of 204 emergency patients finds 18-gauge and 20-gauge IV catheters cause comparable insertion pain and procedural difficulty

Meta-analysis of 9,127 critically ill patients finds pantoprazole halves clinically important GI bleeding without increasing pneumonia or C. diff