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First clinical study evaluating the use of PuraBond for the reduction of post-op haemorrhage and post-op complications in Transoral Robotic Surgery (TORS)

Written by 3-D Matrix | Oct 25, 2022 8:02:43 AM

The use of Transoral Robotic surgery (TORS) is increasingly growing in Head and Neck and in Ear, Nose and Throat Surgery. TORS constitutes a viable treatment option, enabling access to difficult-to-reach cancers. However, the technique also brings some risks, including post-operative haemorrhage (incidence rate 4.1%-9.8%).

In the publication Evaluating the role of the self-assembling topical haemostat PuraBond in Transoral Robotic Surgery (TORS) for oropharyngeal cancer: A case series (Ann Med Surg, 2022) by Dr Mriganka De et al., the investigators evaluated the potential benefits of the use of PuraBond in 12 patients undergoing TORS surgery for Human Papilloma Virus (HVP) positive oropharyngeal squamous cell carcinoma.

After the completion of the resection and adequate haemostasis was achieved, 3 ml of PuraBond was applied to the surgical bed of the TORS resection site.

The outcome measures included post-operative haemorrhage rates and post-operative complications and requirements.

The results were as follows (% patients):

  • Primary haemorrhage (within 24h): 0%
  • Secondary haemorrhage (within 30 days): 0%
  • Requirement of feeding tube: 0%
  • Requirement of tracheostomy: 0%
  • Average length of hospital stay (days): 2.87
  • Hospital readmission: 0%
  • Swallowing outcomes: 100% resumed an oral diet on day 1 post-TORS
  • Reported ‘easy’ application of PuraBond: 100%

This study supports the feasibility and safety of PuraBond use in TORS in view of the promising early findings, especially with regard to post-operative haemorrhage rates and swallowing outcomes, both Key Performance Indicators (KPIs) for TORS.

Further studies with extended follow-up are required to better define whether the known haemostatic and regenerative properties of PuraBond translate into direct patient benefits in TORS.

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