PuraBond PROOF v0.5
Research type
Research Study
Full title
A randomised controlled trial investigating the use of PuraBond® (3-D Matrix) in transoral resections of primary oral or oropharyngeal mucosal lesions
IRAS ID
322447
Contact name
Jason Fleming
Contact email
Sponsor organisation
University of Liverpool
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
PuraBond® PROOF is a non-CTIMP prospective, single centre, parallel group randomised controlled trial. PuraBond® is haemostatic agent, classified as a CE marked class III medical device, that is applied to surgical fields and has been shown to be safe to use and effective in reducing bleeding. This trial will look to investigate the impact of applying PuraBond® in oral cavity or oropharyngeal operations on post-operative pain outcomes. In the PuraBond® PROOF trial, patients undergoing a pre-determined set of operations in either the mouth or oropharynx will be randomised to either receive PuraBond® during the operation or not. This allocation will be random and both treatments are currently used as part of routine standard clinical practice. Participants will be asked to monitor and record their pain levels on days 1, 2, 4, 7, 14 and 30 after their operation by marking their pain level on a continuous scale from ‘no pain’ to ‘the worse possible pain’. This will be the first trial to look at PuraBond® use in head and neck surgery with pain being the primary trial outcome. Secondary outcomes will evaluate post-operative complication rates, recovery outcomes and assess if there is any cost benefit to PuraBond® use.
Lay summary of study results: Head and Neck Cancer covers many different types of cancers such as those in the mouth (oral cavity) and middle of the throat (oropharynx). Patients can present with new lesions in the mouth or throat that need investigation. These lesions are often removed as part of an operation as a way of both diagnosing and treating patients with suspected or confirmed cancer. However, operations in the mouth or oropharynx are painful; Pain can affect patients’ quality of life and recovery after surgery. PuraBond is a medical device that contains a gel like material that can be applied to such wounds. It forms a barrier over the wound that may help reduce bleeding.
This research aimed to find out if applying PuraBond onto such wounds in the oral cavity or oropharynx also helped reduce pain after surgery. We suspected that the gel like barrier it creates over the wound also makes it less sensitive to pain. To answer this question, we consulted members of Merseyside Head and Neck Cancer Research Forum who helped with designing the research.
The PuraBond PROOF study was conducted at Aintree University Hospital (Liverpool Head and Neck Centre) between October 2023-August 2024. The study included adults who had surgery through the mouth to remove confirmed or suspected cancer in the oral cavity or oropharynx. Participants were randomly divided into two groups to reduce differences between groups: one group had PuraBond applied to their wound, while the other group had nothing. The patients and researchers did not know who was given which treatment. The trial monitored participants for 30 days to assess their health outcomes, including pain levels (using a 10cm visual analogue scale) and bleeding rates.
In total 68 patients took part in the study (32 in the PuraBond group and 36 in the ‘no PuraBond’ group). The main finding was that having PuraBond applied to these wounds at the end of surgery significantly reduced the total pain patients experienced over the 30 days. Importantly, this reduction may represent a real decrease in pain intensity particularly over the first two weeks from surgery. Despite this, there was no difference between the two groups in terms of how long they remained in hospital or how quickly they began eating orally after surgery.The number of bleeding events after surgery was almost three times greater in patients with no PuraBond compared to those that had it applied. However, it is unclear if this difference between the groups is likely to be by chance rather than a difference caused by PuraBond as it was a small study. Further research is needed to confirm if PuraBond provides any benefit with regards to reducing the risk of bleeding after surgery.
We would like to thank all study participants for taking part. This research was sponsored by the University of Liverpool and funded by 3-D Matrix Ltd.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
23/NW/0056
Date of REC Opinion
7 Mar 2023
REC opinion
Favourable Opinion