Treatment of Osteomyelitis-associated Pressure Ulcers by Surgical Flaps and Anti-bacterial Agents

NCT05713149 | Recruiting

• 1 other identifier: 2023-001
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

People with neuromotor disability (i.e. following an inborn or acquired spinal cord, cerebral or peripheral neurological lesion) are at high risk of osteomyelitis-associated pressure ulcers. The management of osteomyelitis-associated pressure ulcers is controversial. In our center, patients benefit from a one stage surgical management with bone shaving and flap covering osteitis of pressure ulcer to perform wound closing. Surgery is followed by an antibiotic treatment, secondarily adapted to intraoperative samples. The aim of this study is to describe the cohort and to identify factors associated with failure (or success) in this frail population.

Conditions

Disability or Chronic Disease Leading to Disablement; Pressure Ulcer; Osteomyelitis

Keywords

Disability, Pressure Ulcer, Osteomyelitis, Surgical Flaps, Anti-bacterial agents, Posture

Outcome Measures

Primary Outcomes (1)

• Success at 12 months after surgery

  Success is defined as the absence of surgical revision, the absence of additional antibiotic therapy, and the absence of local care at the surgical site.

  12 months after surgery

Secondary Outcomes (3)

• Success at 30-45 days after surgery

  30-45 days after surgery (depening on the surgical technique)

• Description of the patients' bacteriological tests

  Through hospital admission, up to 7 days after surgery

• Death

  12 months after surgery

Study Arms (1)

Subjects with osteomyelitis-associated pressure ulcers

Subjects with neuromotor disability and admitted for the treatment of osteomyelitis-associated pressure ulcers

Other: Surgical flap and anti-bacterial agents

Interventions

Surgical flap and anti-bacterial agents OTHER

Surgical flap and anti-bacterial agents

Subjects with osteomyelitis-associated pressure ulcers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with neuromotor disability and admitted for the treatment of osteomyelitis-associated pressure ulcers by surgical flaps and antibacterial treatment.

You may qualify if:

• Patients \>= 18 years old ;
• Treated in the Perioperative Disability Unit (UPOH) of the Physical Medicine and Rehabilitation Department of our university hospital;
• Admitted for the treatment of an osteomyelitis-associated pressure ulcer by surgical flap;
• Having a neuromotor disability;
• No opposition to be enrolled in the study from the patient, or from a legally authorized close relative if the patient's state of health does not allow it;
• Affiliation to a social security scheme.

You may not qualify if:

• Under court protection.

Sponsors & Collaborators

• Institut de Sante Parasport Connecte Synergies: lead
• Assistance Publique - Hôpitaux de Paris: collaborator

Study Sites (1)

Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP

Garches, 92380, France

RECRUITING

MeSH Terms

Conditions

Pressure Ulcer; Osteomyelitis

Interventions

Surgical Flaps; Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Surgically-Created Structures; Equipment and Supplies; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• François Genêt, MD-PhD

  Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

François Genêt, MD-PhD

CONTACT

+ 33 1 47 10 70 82; françois.genet@aphp.fr

Vincent T. Carpentier, MD-MSc

CONTACT

+ 33 1 47 10 70 82; vincent.carpentier@ispc-synergies.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: February 6, 2023
• Study Start: February 19, 2023
• Primary Completion: February 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)