SCENIC v2.2
Research type
Research Study
Full title
SCENIC - Statseal for CENtral venous catheter insertion sites In Critical care. An adaptive randomised controlled trial, performed in a cardiothoracic theatre and critical care setting, to investigate the integrity and durability of standard care dressings compared with use of an additional haemostatic powder, to cover and protect central venous catheter insertion sites.
IRAS ID
338511
Contact name
Owen Chambers
Contact email
Sponsor organisation
Liverpool Heart and Chest Hospital
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 9 months, 0 days
Research summary
Research Summary
This research compares ways to cover and protect central venous catheter skin insertion sites.
Central venous catheters are inserted into large veins to allow rapid, repeated or continuous administration of blood, fluids or medications. In this research, all patients will be undergoing heart or lung surgery. A catheter will be inserted into the internal jugular vein of the neck by an anaesthetist (this usually takes place after the patient is anaesthetised). The catheter is stitched in place and the site is then protected with a sterile dressing. The catheter can be used during the operation and in the recovery period on the critical care ward.
Sometimes the skin around the insertion site can ooze small amounts of blood, sometimes the skin beneath a dressing may sweat. Both of these things can prevent the dressing from staying clean and dry, and from sticking to the skin. Dressings that become moist or loose need to be changed more frequently. All of these things can increase the risk of infection including life-threatening bloodstream infection. Dressing changes can be uncomfortable for patients, can irritate or damage the skin and are best avoided if at all possible. Current evidence recommends that is safe and preferable to leave clean, dry and intact central venous catheter dressings undisturbed for up to seven days.Current standard care involves covering catheter insertion sites with a transparent dressing. We would like to compare this, with the additional application of a mineral-based powder product that aids aids clotting and so may reduce the risk of bleeding. The absorbent properties of the powder may also help the area beneath the dressing remain dry from sweat or other body fluids. The powder would be applied just after the catheter is inserted; the site with the powder is then covered with the same standard-care transparent dressing.
Summary of Results
This trial compared two different dressing strategies for internal jugular central venous catheter access sites, in participants undergoing non-emergent cardiac surgery. No difference was observed in dressing durations between conventional semi-permeable transparent dressings and the addition of a hemostatic powder. The removal of most dressings in both groups at around 24 hours was consistent with post-operative recovery. Some advantages were observed in relation to hemostatic powder use which may indicate potential benefit for patients with elevated bleeding risk. Incidence of skin irritation or injury was negligible for both groups and were minor in each case.
REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
24/NW/0082
Date of REC Opinion
16 Apr 2024
REC opinion
Further Information Favourable Opinion