Evidence map›Paper›PMID 25873529›Full record

Trial reportTrials2015

Clinical trial to evaluate the performance of a flexible self-adherent absorbent dressing coated with a soft silicone layer compared to a standard wound dressing after orthopedic or spinal surgery: study protocol for a randomized controlled trial.

Jan Bredow, Johannes Oppermann, Katharina Hoffmann, Martin Hellmich, Birte Wenk, Marvin Simons, Peer Eysel, Kourosh Zarghooni

Registry-linked trialOpen access · goldAbstract readComparative StudyRandomized Controlled Trial
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 NCT01988818 (A Mono-centre, Post CE-mark, Prospective-randomized Clinical Trial to Evaluate the Performance of a Flexible Self-adherent Absorbent Dressing Coated With a Soft Silicone Layer After Hip or Knee Arthroplasty or Primary Spine Surgery in Comparison to a Standard Wound Dressing), which is not on this map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
0.9field-weighted citation impact, top 24% 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.

NCT01988818 nacompletednot on this map

A Mono-centre, Post CE-mark, Prospective-randomized Clinical Trial to Evaluate the Performance of a Flexible Self-adherent Absorbent Dressing Coated With a Soft Silicone Layer After Hip or Knee Arthroplasty or Primary Spine Surgery in Comparison to a Standard Wound Dressing (Cosmopor E®Steril, Fa. Hartmann)

TypeinterventionalSponsorUniversity of CologneRan2014 to 2016Enrolled200ConditionsHip-surgery, Knee-surgery, Spinal-surgeryArmsMepilex® Border Post-Op, standard wound dressing
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 2 syntheses or guidelines pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Evaluation of Absorbent Versus Conventional Wound Dressing.Deutsches Arzteblatt international · 2018
    Article
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

8 authors at 2 institutions in 1 country.

Jan BredowDepartment of Orthopedics and Trauma Surgery, University Hospital of Cologne, Kerpener Str. 62, Cologne, D - 50924, Germany. jan.bredow@uk-koeln.de.
Johannes OppermannDepartment of Orthopedics and Trauma Surgery, University Hospital of Cologne, Kerpener Str. 62, Cologne, D - 50924, Germany. johannes.oppermann@uk-koeln.de.
Katharina HoffmannClinical Trials Centre, BMBF 01KN0706, University of Cologne, Kerpener Str. 62, Cologne, 50924, Germany. studienzentrum-ortho-unfall@uk-koeln.de.
Martin HellmichInstitute of Medical Statistics, Informatics and Epidemiology, University of Cologne, Kerpener Str. 62, Cologne, 50924, Germany. martin.hellmich@uni-koeln.de.
Birte WenkDepartment of Orthopedics and Trauma Surgery, University Hospital of Cologne, Kerpener Str. 62, Cologne, D - 50924, Germany. birte.wenk@uk-koeln.de.
Marvin SimonsDepartment of Orthopedics and Trauma Surgery, University Hospital of Cologne, Kerpener Str. 62, Cologne, D - 50924, Germany. raoul.simons@uk-koeln.de.
Peer EyselDepartment of Orthopedics and Trauma Surgery, University Hospital of Cologne, Kerpener Str. 62, Cologne, D - 50924, Germany. peer.eysel@uk-koeln.de.
Kourosh ZarghooniDepartment of Orthopedics and Trauma Surgery, University Hospital of Cologne, Kerpener Str. 62, Cologne, D - 50924, Germany. kourosh.zarghooni@uk-koeln.de.
University Hospital Cologne · DEUniversity of Cologne · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPostoperative wound infection is a preventable risk. One potential postoperative complication is blistering, which leads to increased pain, delayed healing, and higher care costs. The incidence of wound blisters has been reported to be between 6 and 24%. The aim of this study is to assess whether the risks of postoperative blistering and wound infections within the first 6 days postsurgery will be reduced using a special dressing compared to a standard one. METHODS/

designThis is a randomized clinical trial in a University hospital. Patients presenting for knee or hip arthroplasty or spine procedures will be assessed against study inclusion and exclusion criteria. After giving written informed consent, patients will be randomized to participate in the 7-day study during hospitalization. One hundred patients will be randomized per group. The primary outcome measure is blistering incidence from day 0 to day 6 postsurgery. Photo documentation will be evaluated in a blinded manner by the Clinical Evaluation Committee (CEC). DISCUSSION: A new dressing will be compared to the standard wound dressing regarding the risk of postoperative blistering, wound infection, and patient comfort. This study will assess the potential advantages of a modern wound dressing.

trial registrationClinicalTrials.gov identifier NCT01988818 (Entered 13 November 2011).

Indexed as

BandagesCoated Materials, BiocompatibleSiliconesWound HealingAdhesivenessArthroplasty, Replacement, HipArthroplasty, Replacement, KneeBlisterClinical ProtocolsEquipment DesignGermanyHospitals, UniversityHumansMaterials TestingOrthopedic ProceduresPatient SatisfactionCoated Materials, BiocompatibleSilicones

Identifiers

PMID25873529
PMCPMC4367919
OpenAlexW2109709932

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.