Evidence map›Paper›PMID 26537879›Full record

Trial reportTrials2015

Negative pressure wound therapy for high-risk wounds in lower extremity revascularization: study protocol for a randomized controlled trial.

Patrick Murphy, Kevin Lee, Luc Dubois, Guy DeRose, Thomas Forbes, Adam Power

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02084017 (Single Center Prospective Randomized Control Trial on Negative Pressure Wound Therapy for Primarily Closed Groin Incisions Following Lower-limb Re-vascularization to Reduce Surgical Site Infection), which is not on this map. Cited by 8 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 6 pooled it
1.5field-weighted citation impact, top 18% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02084017 phase1 / phase2unknown statusnot on this map

Single Center Prospective Randomized Control Trial on Negative Pressure Wound Therapy for Primarily Closed Groin Incisions Following Lower-limb Re-vascularization to Reduce Surgical Site Infection

TypeinterventionalSponsorWestern University, CanadaRan2014 to 2016Enrolled80ConditionsSurgical Wound Infection, Peripheral Vascular DiseasesArmsPrevena (Negative Pressure Wound Therapy Device), Standard Tegaderm (3M Healthcare, St. Paul, MN) adhesive dressing
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 6 syntheses or guidelines pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Transverse versus vertical groin incision for femoral artery approach.The Cochrane database of systematic reviews · 2020
    Pooled it
  7. Steroids in cardiac surgery trial: a substudy of surgical site infections.Canadian journal of anaesthesia = Journal canadien d'anesthesie · 2019
    Trial
  8. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 1 country.

Patrick MurphyDivision of General Surgery, Department of Surgery, Western University, 1151 Richmond Street, London, ON, N6A 5A5, Canada. patrick.murphy@londonhospitals.ca.
Kevin LeeDivision of Vascular Surgery, Department of Surgery, Western University, 800 Commissioners Road East, London, ON, N6A 4G5, Canada. leekev10@gmail.com.
Luc DuboisDivision of Vascular Surgery, Department of Surgery, Western University, 800 Commissioners Road East, London, ON, N6A 4G5, Canada. luc.dubois@lhsc.on.ca.
Guy DeRoseDivision of Vascular Surgery, Department of Surgery, Western University, 800 Commissioners Road East, London, ON, N6A 4G5, Canada. guy.derose@lhsc.on.ca.
Thomas ForbesDivision of Vascular Surgery, Department of Surgery, University of Toronto, 149 College Street, Toronto, ON, M5T 1P5, Canada. tom.forbes@lhsc.on.ca.
Adam PowerDivision of Vascular Surgery, Department of Surgery, Western University, 800 Commissioners Road East, London, ON, N6A 4G5, Canada. adam.power@lhsc.on.ca.
Western University · CAUniversity of Toronto · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRates of surgical site infections (SSIs) following groin incision for femoral artery exposure are much higher than expected of a clean operation. The morbidity and mortality is high, particularly with the use of prosthetic grafts. The vascular surgery population is at an increased risk of SSIs related to peripheral vascular disease (PVD), diabetes, obesity, previous surgery and presence of tissue loss. Negative pressure wound therapy (NPWT) dressings have been used on primarily closed incisions to reduce surgical site infections in other surgical disciplines. We have not come across any randomized controlled trials to support the prophylactic use of negative pressure wound therapy in high-risk vascular patients undergoing lower limb revascularization. METHODS/

designIn this single-center, prospective randomized controlled trial, patients scheduled for a lower limb revascularization requiring open femoral artery exposure who are at a high risk (BMI > 30 kg/m(2), previous femoral cutdown or Rutherford V or VI category for chronic limb ischemia) will be eligible for the study. A total of 108 groin incisions will be randomized to the use of a negative pressure wound device or standard adhesive gauze dressing. Patients will be followed in hospital and reassessed within the first 30 days postoperatively. The primary outcome is SSI within the first 30 days of surgery and will be determined using the intention-to-treat principle. Secondary outcomes include length of stay, emergency room visits, reoperation, amputation and mortality. A cost analysis will be performed. DISCUSSION: The trial is expected to define the role of NPWT in SSI prophylaxis for lower limb revascularization in high-risk vascular patients. The results of the study will be used to inform current best practice for perioperative care and the minimization of SSIs.

trial registrationNCT02084017 , March 2014.

Indexed as

Negative-Pressure Wound TherapyAmputation, SurgicalClinical ProtocolsCost-Benefit AnalysisEmergency Service, HospitalFemoral ArteryHealth Care CostsHumansLength of StayLimb SalvageLower ExtremityOntarioPeripheral Arterial DiseaseProspective StudiesReoperationResearch Design

Identifiers

PMID26537879
PMCPMC4634141
OpenAlexW2116120551

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.