Application Detail

Description of Medical Service

DAC is a kit designed for the preparation of a bio-resorbable antibiotic loaded hydrogel, composed of hyaluronan and poly-D,L-lactide copolymer. DAC must be rehydrated using an antibiotic solution. The DAC+antibiotics hydrogel is applied to the surfaces of implants in the orthopaedic and traumatology fields.

Description of Medical Condition

The kit is intended to be used for patients at increased risk of periprosthetic infection due to colonisation of an orthopaedic implant during the implant procedure.

Condition 1: Patients with comorbidities known to increase the risk of infection receiving a primary joint implant.

Condition 2: Patients undergoing mega prosthesis implantation or major revision joint implants for indications other than peri-prosthetic infection i.e. total joint revision, tumour removal and reconstruction.

Condition 3: Patients undergoing surgery for peri prosthetic infection with implant replacement.

Condition 4: Patients undergoing open reduction and internal fixation.

Reason for Application

Novel, new product

Medical Service Type

Therapeutic

Previous Application Number/s

Not Applicable

Associated Documentation

Application Form

Application Form (PDF 1053 KB)
Application Form (Word 107 KB)

Consultation Survey

Consultation Survey (PDF 218 KB)
Consultation Survey (Word 73 KB)

PASC Consultation
PASC consultation closed

MSAC Consultation
MSAC consultation input closed Friday, 7 October 2022.

For further information please refer to PASC, ESC, MSAC Key Dates
For further information on the consultation process please refer to MSAC Consultation Process

PICO Confirmation

PICO Confirmation (PDF 1502 KB)
PICO Confirmation (Word 378 KB)

Assessment Report

-

Public Summary Document

Public Summary Document (PDF 871 KB)
Public Summary Document (Word 545 KB)

Meetings for this Application

PASC

13 August 2020

ESC

6-7 October 2022

MSAC

24-25 November 2022