An interventional study of Defensive Antiadhesive Coating DAC®, Novagenit SRL in Hip Prosthesis Infection, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Active, not recruiting at 14 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-06.
Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Not applicable, Interventional, and Treatment
Each year, around 1500 infected Total Hip Arthroplasties (THA) need non-conservative surgery, remaining an issue for patients and healthcare units. The recommended treatment, relying on cohort reviews and international consensus follows a two-stage protocol. This protocol implies a first surgery to remove all infected implants and at least 6 weeks of antibiotic treatment without implant, then usually an antibiotic-free period and only then a second surgery to put back new implants and start the rehabilitation protocol, with usually more than a week of a second hospital stay. Between both surgeries, full-weight bearing is prohibited and joint stiffness and/or pain are rather usual complications. Failure rate is estimated at 10% in this two-stage strategy. The single-stage procedure (i.e. implanting back a new prosthesis during the same surgery after implant removal, synovectomy and lavage) is thought to be less susceptible to late functional complications (i.e. pain, stiffness and muscle deficiency) with a shorter, single hospital stay.
Although, with single-stage surgery, infection control could be less efficient because most pathogens produce during the first hours of infection an antibiotic-resistant layer called biofilm, allowing them to colonize and adhere to foreign objects like implants. This single-surgery protocol thus highly relies on antibiotics and has a list of contra-indications (based on experts' consensus): the presence of damaged soft tissues or a sinus tract, unknown pathogens, difficult to treat micro-organisms, severe immunosuppression and for many surgeons, each time a bone graft is necessary. Most of these contra-indications are directly related to the biofilm.
As no randomized control trial has ever compared single-stage versus two-stage surgery, the level of evidence for recommending one procedure over the other is low.
We conducted a survey that showed that most of the French reference centers have already switched to single stage surgery for single-stage non contra-indicated cases.
An antibiotic-loaded hydrogel coating (Defensive Antiadhesive Coating®, Novagenit SRL), has been proven to mechanically prevent the biofilm formation, while allowing a prolonged intraarticular antibiotic release, in a randomized controlled trial in primary prevention of infection in THA.
The addition of this biofilm inhibitor to a single-stage surgery might stand as a promising strategy for secondary prevention of peri-prosthetic hip joint infection. Moreover, using this device to prevent biofilm formation could expand one stage surgery to patients that are "normally" contra-indicated to one stage surgery.
44 studies on the registry are indexed under Persistent Infection; 5 are open to participants now.
This study's enrollment of 39 is below the median of 104 across 28 interventional studies indexed under Persistent Infection.
Browse Persistent Infection studies →Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 597 studies on the registry; 127 are open to participants now.
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The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Experimental group is composed of single-stage procedure associated to the use of biofilm inhibitor (Defensive Antibacterial Coating® DAC®) and topical antibiotics=new strategy
Device: Defensive Antiadhesive Coating DAC®, Novagenit SRL
Control group is composed of two-stage procedure without biofilm inhibitor (standard protocol)
DAC gel, mixed with topical antibiotics is applied on the surface of the implants before implantation, in a sterile environment in the operating room. The topical antibiotics will be added to the reconstituted DAC® gel preparation, at the discretion of the physician, on the basis of pre-operative culture.
Recurrence of clinically diagnosed infection relapse of the periprosthetic joint
The periprosthetic joint infection is defined according to the Musculoskeletal Infection Society criteria: * Two positive periprosthetic cultures with phenotypically identical organisms * or a sinus tract communicating with the joint, * or having 3 of 5 minor criteria: * Elevated serum C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR); * Elevated synovial fluid white blood cell (WBC) count; * Elevated synovial fluid polymorphonuclear neutrophil percentage (PMN%); * Positive histological analysis of periprosthetic tissue; * A single positive culture.
Time frame: Years : 2
Harris Hip Score (HHS) results
Harris Hip Score (HHS) contains 10 items with maximum score at 100 for a perfect hip and minimum score at 0 for a very bad result.
Time frame: Years : 2
Postel-Merle d'Aubigné (PMA) results
Postel-Merle d'Aubigné (PMA) contains 3 items (pain, mobility and functional hip) with maximum score at 18 for a perfect hip and minimum score at 0 for a very bad result.
Time frame: Years : 2
Hip dysfunction and Osteoarthritis Outcome Score (HOOS) results
Hip dysfunction and Osteoarthritis Outcome Score contains 6 items (symptoms, stiffness, pain, function and daily life, sport and leisure activities, quality of life) and measure everyday activities with score from 0 to 4.
Time frame: Years : 2
Oxford-12 results
Oxford-12 allows to know the feelings of the patient during the last 4 weeks felt from 1 to 5 (satisfaction score).
Time frame: Years : 2
Death rate (%)
Analysis of death rate by group.
Time frame: Years : 2
Post-operative complications
Analysis of post-operative complications by group.
Time frame: Years : 2
Revision surgery for any cause other than infection
Analysis of revision surgery for any cause other than infection.
Time frame: Years : 2
Plan to share: No
This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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