Evidence map›Paper›PMID 25340801›Full record

Trial reportPloS one2014

PXL01 in sodium hyaluronate for improvement of hand recovery after flexor tendon repair surgery: randomized controlled trial.

Monica E Wiig, Lars B Dahlin, Jan Fridén, Lars Hagberg, Sören E Larsen, Kerstin Wiklund, Margit Mahlapuu

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

Trial report in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01022242 (A Prospective Double-blind, Randomised Concept Study of PXL01 Versus Placebo in Flexor Tendon Surgery), which is not on this map. Cited by 26 papers.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed
2.9field-weighted citation impact, top 9% 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.

NCT01022242 phase2completednot on this map

A Prospective Double-blind, Randomised Concept Study of PXL01 Versus Placebo in Flexor Tendon Surgery

TypeinterventionalSponsorPergamum ABRan2009 to 2013Enrolled138ConditionsSurgical AdhesionsArmsPXL01, Placebo
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 55 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. Antimicrobial peptides: from discovery to developmental applications.Applied and environmental microbiology · 2025
    Review
  5. Article
  6. Review
  7. Peritendinous adhesion: Therapeutic targets and progress of drug therapy.Computational and structural biotechnology journal · 2024
    Review
  8. Article
  9. Optimizing tendon repair and regeneration: how does theFrontiers in bioengineering and biotechnology · 2024
    Review
  10. Review
  11. Article
  12. Are Antimicrobial Peptides a 21st-Century Solution for Atopic Dermatitis?International journal of molecular sciences · 2023
    Review
  13. Review
  14. Review
  15. Review
  16. Review
  17. Review
  18. Review
  19. Article
  20. 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

7 authors at 5 institutions in 2 countries.

Monica E WiigDepartment of Surgical Science, Hand Surgery, Uppsala University, Uppsala, Sweden; Uppsala University Hospital, Uppsala, Sweden.
Lars B DahlinDepartment of Clinical Sciences Malmö - Hand Surgery, Lund University, Skåne University Hospital, Malmö, Sweden.
Jan FridénDepartment of Hand Surgery, Sahlgrenska University Hospital, Göteborg, Sweden.
Lars HagbergDepartment of Hand Surgery, Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.
Sören E LarsenDepartment for Orthopaedics, Unit for Hand Surgery, Odense University Hospital, Odense, Denmark.
Kerstin WiklundPharma Consulting Group Solutions AB, Uppsala, Sweden.
Margit MahlapuuPergamum AB, Stockholm, Sweden.
Lund University · SEOdense University Hospital · DKSahlgrenska University Hospital · SEStockholm South General Hospital · SEUppsala University Hospital · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPostoperative adhesions constitute a substantial clinical problem in hand surgery. Fexor tendon injury and repair result in adhesion formation around the tendon, which restricts the gliding function of the tendon, leading to decreased digit mobility and impaired hand recovery. This study evaluated the efficacy and safety of the peptide PXL01 in preventing adhesions, and correspondingly improving hand function, in flexor tendon repair surgery.

methodsThis prospective, randomised, double-blind trial included 138 patients admitted for flexor tendon repair surgery. PXL01 in carrier sodium hyaluronate or placebo was administered around the repaired tendon. Efficacy was assessed by total active motion of the injured finger, tip-to-crease distance, sensory function, tenolysis rate and grip strength, and safety parameters were followed, for 12 months post-surgery.

resultsThe most pronounced difference between the treatment groups was observed at 6 months post-surgery. At this timepoint, the total active motion of the distal finger joint was improved in the PXL01 group (60 vs. 41 degrees for PXL01 vs. placebo group, p = 0.016 in PPAS). The proportion of patients with excellent/good digit mobility was higher in the PXL01 group (61% vs. 38%, p = 0.0499 in PPAS). Consistently, the PXL01 group presented improved tip-to-crease distance (5.0 vs. 15.5 mm for PXL01 vs. placebo group, p = 0.048 in PPAS). Sensory evaluation showed that more patients in the PXL01 group felt the thinnest monofilaments (FAS: 74% vs. 35%, p = 0.021; PPAS: 76% vs. 35%, p = 0.016). At 12 months post-surgery, more patients in the placebo group were considered to benefit from tenolysis (30% vs. 12%, p = 0.086 in PPAS). The treatment was safe, well tolerated, and did not increase the rate of tendon rupture.

conclusionsTreatment with PXL01 in sodium hyaluronate improves hand recovery after flexor tendon repair surgery. Further clinical trials are warranted to determine the most efficient dose and health economic benefits.

trial registrationClinicalTrials.gov NCT01022242; EU Clinical Trials 2009-012703-25.

Indexed as

Recovery of FunctionAdultFemaleFinger InjuriesFinger JointHandHand StrengthHumansHyaluronic AcidLactoferrinMalePatient ComplianceRange of Motion, ArticularSensationTendon InjuriesTreatment OutcomeHyaluronic AcidLactoferrinPXL01 peptide

Identifiers

PMID25340801
PMCPMC4207831
OpenAlexW2143969153

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.