Evidence map›Paper›PMID 26945575›Full record

Trial reportTrials2016

Clinical effectiveness, quality of life and cost-effectiveness of Flaminal® versus Flamazine® in the treatment of partial thickness burns: study protocol for a randomized controlled trial.

Zjir M Rashaan, Pieta Krijnen, M Elske van den Akker-van Marle, Margriet E van Baar, Adrianus F P Vloemans, Jan Dokter, Fenike R H Tempelman, Cees H van der Vlies, Roelf S Breederveld

Open access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
2.2field-weighted citation impact, top 14% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 20 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Long-term quality of life and cost-effectiveness of treatment of partial thickness burns: A randomized controlled trial comparing enzyme alginogel vs silver sulfadiazine (FLAM study).Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society · 2020
    Trial
  4. Flaminal® versus Flamazine® in the treatment of partial thickness burns: A randomized controlled trial on clinical effectiveness and scar quality (FLAM study).Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society · 2019
    Trial
  5. Review
  6. Review
  7. Article
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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

9 authors at 3 institutions in 1 country.

Zjir M RashaanDepartment of Surgery, Leiden University Medical Center, Postbus 9600, 2333 ZA, Leiden, The Netherlands. zrashaan@rkz.nl.
Pieta KrijnenDepartment of Surgery, Leiden University Medical Center, Postbus 9600, 2333 ZA, Leiden, The Netherlands. p.krijnen@lumc.nl.
M Elske van den Akker-van MarleDepartment of Medical Decision Making, Leiden University Medical Centre, PO 9600, 2333 ZA, Leiden, The Netherlands. m.e.van_den_akker-van_marle@lumc.nl.
Margriet E van BaarAssociation of Dutch Burn Centres, Postbus 1015, 1940 EA, Beverwijk, The Netherlands. BaarM@maasstadziekenhuis.nl.
Adrianus F P VloemansBurn Centre, Red Cross Hospital Beverwijk, Postbus 1074, 1942 LE, Beverwijk, The Netherlands. jvloemans@rkz.nl.
Jan DokterBurn Centre, Maasstad Hospital, PO Box 9100, 3079 DZ, Rotterdam, The Netherlands. dokterj@maasstadziekenhuis.nl.
Fenike R H TempelmanBurn Centre, Red Cross Hospital Beverwijk, Postbus 1074, 1942 LE, Beverwijk, The Netherlands. ftempelman@rkz.nl.
Cees H van der VliesBurn Centre, Maasstad Hospital, PO Box 9100, 3079 DZ, Rotterdam, The Netherlands. vliesc@maasstadziekenhuis.nl.
Roelf S BreederveldDepartment of Surgery, Leiden University Medical Center, Postbus 9600, 2333 ZA, Leiden, The Netherlands. rbreederveld@rkz.nl.
Association of Dutch Burn Centres · NLLeiden University Medical Center · NLLeiden University · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPartial thickness burns are painful, difficult to manage and can have a negative effect on quality of life through scarring, permanent disfigurement and loss of function. The aim of burn treatment in partial thickness burns is to save lives, stimulate wound healing by creating an optimumly moist wound environment, to have debriding and analgesic effects, protect the wound from infection and be convenient for the patient and caregivers. However, there is no consensus on the optimal treatment of partial thickness wounds. Flaminal® and Flamazine® are two standard treatment options that provide the above mentioned properties in burn treatment. Nevertheless, no randomized controlled study has yet compared these two common treatment modalities in partial thickness burns. Thus, the aim of this study is to evaluate the clinical effectiveness, quality of life and cost-effectiveness of Flaminal® versus Flamazine® in the treatment of partial thickness burns. METHODS/

designIn this two-arm open multi-center randomized controlled trial, 90 patients will be randomized between Flaminal® and Flamazine® and followed for 12 months. The study population will consist of competent or temporarily non-competent (because of sedation and/or intubation) patients, 18 years of age or older, with acute partial thickness burns and a total body surface area (TBSA) of less than 30 %. The main study outcome is time to complete re-epithelialization (greater than 95 %). Secondary outcome measures include need for grafting, wound colonization/infection, number of dressing changes, pain and anxiety, scar formation, health-related quality of life (HRQoL), and costs. DISCUSSION: This study will contribute to the optimal treatment of patients with partial thickness burn wounds and will provide evidence on the (cost-)effectiveness and quality of life of Flaminal® versus Flamazine® in the treatment of partial thickness burns.

trial registrationNetherlands Trial Register NTR4486 , registered on 2 April 2014.

Indexed as

Drug CostsQuality of LifeAlginatesAnti-Infective Agents, LocalBurnsCicatrixClinical ProtocolsCost-Benefit AnalysisDrug CombinationsGlucose OxidaseHumansLactoperoxidaseNetherlandsPainPolyethylene GlycolsRe-EpithelializationAlginatesAnti-Infective Agents, LocalDrug CombinationsFlaminalGlucose OxidaseLactoperoxidasePolyethylene GlycolsSilver Sulfadiazine

Identifiers

PMID26945575
PMCPMC4779241
OpenAlexW2290632304

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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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.