Evidence map›Paper›PMID 31661012›Full record

Trial reportTrials2019

CICAFAST: comparison of a biological dressing composed of fetal fibroblasts and keratinocytes on a split-thickness skin graft donor site versus a traditional dressing: a randomized controlled trial.

Alexandra Poinas, Pierre Perrot, Judith Lorant, Olivier Nerrière, Jean-Michel Nguyen, Soraya Saiagh, Cécile Frenard, Audrey Leduc, Olivier Malard, Florent Espitalier and 5 more

Registry-linked trialOpen access · goldAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03334656 (Controlled Comparison of a Traditional Dressing Versus a Biologic Dressing Composed of Fetal Fibroblasts and Keratinocytes in Association With a Collagen Matrix on Skin Donor Sites), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
0.8field-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.

NCT03334656 phase1 / phase2terminatednot on this map

Controlled Comparison of a Traditional Dressing Versus a Biologic Dressing Composed of Fetal Fibroblasts and Keratinocytes in Association With a Collagen Matrix on Skin Donor Sites

TypeinterventionalSponsorNantes University HospitalRan2018 to 2024Enrolled28ConditionsSplit Thickness Skin Graft, Wound HealingArmsbiological dressing, Paraffin gauze dressing
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.

  1. Hydrogel dressings for donor sites of split-thickness skin grafts.The Cochrane database of systematic reviews · 2023
    Pooled it
  2. Review
  3. Review
  4. Current Biomaterials for Wound Healing.Bioengineering (Basel, Switzerland) · 2023
    Review
  5. Article
  6. Article
  7. Article
  8. Inflammatory Microenvironment of Skin Wounds.Frontiers in immunology · 2022
    Review
  9. 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

15 authors at 4 institutions in 1 country.

Alexandra PoinasClinical Investigation Centre CIC1413, Nantes INSERM and CHU Nantes, 5, allée de l'île Gloriette, 44093, Nantes Cedex 1, France. alexandra.poinas@chu-nantes.fr.ORCID http://orcid.org/0000-0003-4183-483X
Pierre PerrotPlastic and Reconstructive Surgery Department, Burns Centre, Jean Monnet, CHU Nantes, 30 Boulevard Jean-Monnet, 44093, Nantes Cedex 1, France.
Judith LorantCRCINA, INSERM, Université de Nantes, Nantes, France.
Olivier NerrièreCell and Gene Therapy Unit, CHU Nantes, Place Alexis Ricordeau, 44093, Nantes, France.
Jean-Michel NguyenDepartment of Epidemiology and Biostatistics, CHU Nantes, CRCINA, INSERM 1232, Université de Nantes, Nantes, France.
Soraya SaiaghCell and Gene Therapy Unit, CHU Nantes, Place Alexis Ricordeau, 44093, Nantes, France.
Cécile FrenardDermato-oncology Department, CHU Nantes, CRCINA, INSERM 1232, Université de Nantes, Place Alexis Ricordeau, 44093, Nantes, France.
Audrey LeducPlastic and Reconstructive Surgery Department, Burns Centre, Jean Monnet, CHU Nantes, 30 Boulevard Jean-Monnet, 44093, Nantes Cedex 1, France.
Olivier MalardDepartment of ENT and Cervico-facial Surgery, CHU Nantes, 44093, Nantes, France.
Florent EspitalierDepartment of ENT and Cervico-facial Surgery, CHU Nantes, 44093, Nantes, France.
Franck DuteillePlastic and Reconstructive Surgery Department, Burns Centre, Jean Monnet, CHU Nantes, 30 Boulevard Jean-Monnet, 44093, Nantes Cedex 1, France.
Anne ChiffoleauSponsor Department, CHU Nantes, 5 Allée de L'île Gloriette, 44093, Nantes Cedex 1, France.
Florence VrignaudClinical Investigation Centre CIC1413, Nantes INSERM and CHU Nantes, 5, allée de l'île Gloriette, 44093, Nantes Cedex 1, France.
Amir KhammariClinical Investigation Centre CIC1413, Nantes INSERM and CHU Nantes, 5, allée de l'île Gloriette, 44093, Nantes Cedex 1, France.
Brigitte DrénoClinical Investigation Centre CIC1413, Nantes INSERM and CHU Nantes, 5, allée de l'île Gloriette, 44093, Nantes Cedex 1, France.
Inserm · FRCentre Hospitalier Universitaire de Nantes · FRGene Therapy Laboratory · FRCentre d'Investigation Clinique de Nantes · FR

Funding

Ministère des Affaires Sociales et de la Santé PHRC 2015
6 · The paper itself

Abstract

backgroundWound repair is one of the most complex biological processes of human life. Allogeneic cell-based engineered skin substitutes provide off-the-shelf temporary wound coverage and act as biologically active dressings, releasing growth factors, cytokines and extracellular matrix components essential for proper wound healing. However, they are susceptible to immune rejection and this is their major weakness. Thanks to their low immunogenicity and high effectiveness in regeneration, fetal skin cells represent an attractive alternative to the commonly used autologous and allogeneic skin grafts. METHODS/

designWe developed a new dressing comprising a collagen matrix seeded with a specific ratio of active fetal fibroblasts and keratinocytes. These produce a variety of healing growth factors and cytokines which will increase the speed of wound healing and induce an immunotolerant state, with a slight inflammatory reaction and a reduction in pain. The objective of this study is to demonstrate that the use of this biological dressing for wound healing at the split-thickness skin graft (STSG) donor site, reduces the time to healing, decreases other co-morbidities, such as pain, and improves the appearance of the scar. This investigation will be conducted as part of a randomized study comparing our new biological dressing with a conventional treatment in a single patient, thus avoiding the factors that may influence the healing of a graft donor site. DISCUSSION: This clinical trial should enable the development of a new strategy for STSG donor-wound healing based on a regenerative dressing. The pain experienced in the first few days of STSG healing is well known due to the exposure of sensory nerve endings. Reducing this pain will also reduce analgesic drug intake and the duration of sick leave. Our biological dressing will meet the essential need of surgeons to "re-crop" from existing donor sites, e.g., for thermal-burn patients. By accelerating healing, improving the appearance of the scar and reducing pain, we hope to improve the conditions of treatment for skin grafts.

trial registrationClinicalTrials.gov, ID: NCT03334656 . Registered on 7 November 2017.

Indexed as

Biological DressingsWound HealingFetusFibroblastsHumansKeratinocytesResearch DesignSkin TransplantationTransplant Donor SiteBiological dressingFetal cellsRandomized clinical trialSplit-thickness skin graftWound healing

Identifiers

PMID31661012
PMCPMC6819456
OpenAlexW2981938382

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.