The chronic wound characterisation study and biobank: a study protocol for a prospective observational cohort investigation of bacterial community composition, inflammatory responses and wound-healing trajectories in non-healing wounds

BMJ Open. 2024 Oct 17;14(10):e084081. doi: 10.1136/bmjopen-2024-084081.

Abstract

Introduction: Chronic wounds affect 1%-2% of the global population, with rising incidence due to ageing and lifestyle-related diseases. Bacterial biofilms, found in 80% of chronic wounds, and scattered single-cell bacteria may hinder healing. Microbes are believed to negatively impact healing by exacerbating inflammation and host immune response.

Methods and analysis: The primary objective of the chronic wound characterisation (CWC) study is to investigate chronic wounds through a prospective observational cohort study exploring bacterial community composition, inflammatory responses and the influence of bacteria on wound-healing trajectories. The CWC study will be investigated through two cohorts: the predictive and in-depth.The predictive cohort includes patients with a chronic wound scheduled for mechanical debridement. The debrided material will be collected for dual RNA sequencing and 16s ribosomal RNA gene sequencing, as well as samples for microbial culturing and a photo to assess the wound. Clinical data is recorded, and healing and/or other clinical endpoints are established through medical records.The in-depth cohort includes and follows patients undergoing split-thickness skin grafting. Extensive sampling (ESwabs, biopsies, tape strips, debrided material and a sample of the skin graft) will be performed on surgery and patients will be seen at two follow-up visits. Samples will be analysed through culturing and next-generation sequencing methods. A biobank will be established comprising longitudinal clinical samples and clinical data.

Ethics and dissemination: The study has been approved by the board of health ethics, Capital Region of Denmark, under protocol number H-20032214. The study findings will be disseminated through peer-reviewed publications and showcased at both national and international conferences and meetings within the domains of microbiology, wound healing and infection.

Keywords: Bacteriology; Biopsy; Chronic Disease; Infectious Diseases; Wound Management.

Publication types

  • Observational Study

MeSH terms

  • Bacteria / genetics
  • Bacteria / isolation & purification
  • Biofilms
  • Biological Specimen Banks*
  • Chronic Disease
  • Debridement / methods
  • Humans
  • Inflammation / microbiology
  • Microbiota
  • Observational Studies as Topic
  • Prospective Studies
  • RNA, Ribosomal, 16S / genetics
  • Research Design
  • Skin Transplantation
  • Wound Healing*
  • Wounds and Injuries / microbiology

Substances

  • RNA, Ribosomal, 16S