Prevena incision management system in closed surgical incisions

  • Research type

    Research Study

  • Full title

    Prospective, Active Comparator-Controlled, Pilot Study of PREVENATM (No Ag) Incision Management System in Closed Surgical Incisions (KCI.PREVENA.2020.01)

  • IRAS ID

    292120

  • Contact name

    Abtin Alvand

  • Contact email

    abtin.alvand@ndorms.ox.ac.uk

  • Sponsor organisation

    KCI manufacturing Unlimited Company

  • ISRCTN Number

    ISRCTN96442225

  • Duration of Study in the UK

    1 years, 0 months, 1 days

  • Research summary

    Summary of Research

    This study will enrol 40 participants to evaluate the safety and performance of specialised surgical dressings used over a closed surgical incision with negative pressure therapy (gentle suction), using V.A.C. Therapy®. The study aims to evaluate two types of specialised dressings that are both designed to deliver negative pressure to surgical incisions. The two dressings being evaluated are PREVENA PLUS™ CUSTOMIZABLE™ Dressing-No silver and the PREVENA™ PEEL & PLACE™Dressing-No Silver. Both dressings have already been certified for use over wounds in previous studies and the study is a post-market surveillance study.

    Participants will be enrolled into one of two groups. Group one will receive V.A.C.® Therapy with the V.A.C.® GRANUFOAM™ Dressing frequently used in standard care. Group two will receive PREVENA PLUS™ CUSTOMIZABLE™ Dressing-No silver or PREVENA™ PEEL & PLACE™Dressing-No Silver which are the products being assessed.
    The standard V.A.C.® Therapy group will be enrolled first. After enrolment (20 participants) is complete for the control cohort, the treatment group (20 participants) will be enrolled beginning with the PREVENA PLUS™ CUSTOMIZABLE™ Dressing-No Ag (10 participants) and then the PREVENA™ PEEL & PLACE™ Dressing-No Ag (10 participants).
    Participants will have a dressing placed over the sutured or stapled incision immediately after surgery. The dressing will be worn for 5-7 days post-surgery before discontinuation of negative pressure and dressing removal. Participants will return for a 30-day follow up visit. Patients will be included in the study if the participant has a closed surgical incision with a length of less than 20cm, the wound is clean, is able to provide informed consent and is more than 22 years of age.
    The study will be conducted at two NHS sites, Oxford University Hospitals NHS trust and Manchester University NHS trust.

    Summary of Results

    This study is looking at the safety and general effectiveness of the PREVENA dressings that did not contain silver to determine if this type of dressing is as safe as other negative pressure dressings with silver. Patients are followed for 30 days after surgery with a visit at approximately day 5-7 after surgery and again at 30 days after surgery. In total, 41 subjects enrolled into the study. There are 21 subjects who received the control dressing (VAC Granufoam that contains silver in the dressing), and 20 subjects received the treatment dressings (2 different PREVENA dressings that do not contain silver). All dressings in the study are currently CE marked.
    The average age of the Control patient is 55.8 years (±16.14), and the average age of the Treatment patient is 49.0 years (±18.11). In total, this study enrolled 29 females and 12 males. The average wear time of either dressing for both groups in the study is 5.5 days. The average time in study after surgery is approximately 33 days for patients in the Control group and 40 days for the Treatment group.
    A treatment related adverse event occurring for a patient is the primary endpoint for this study. In total, 7 treatment related adverse events occurred. From the total there are3 adverse events in the Control group and 4 adverse events in the Treatment group. All treatment related adverse events are mild except for 1 skin injury in the Control group that is labeled as moderate. No serious events, serious adverse events or deaths were reported in the study. In addition, no surgical site complications or infections occurred in the study.
    The study was not designed to test any type of formal theory, so clinical judgement was used to determine the number of patients to enroll. Even though the number of enrolled patients was low for the study, the low number of treatment related events and the lack of any surgical site complications or infections suggest that the dressings without silver are a safe treatment option and demonstrate to be as safe as negative pressure dressings with silver.
    For additional study results, please see the posting at https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbZKm4C0TeSkP8lYcMVEmwG51a1bmy2DUTRqXKVLLgTlOSjMH_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YLNjBtw7NDkXLN6ZFGM6kYLE6PbCjjZaUa3n2byQSffmfeSiCLyp7B3WEc0Q9Etn27uVpNAQxossVgP3MdWgQUxc4ZeWbtS5AKZnq5OrPOBQGXg2e8ZOCgtkmzhcg7CrUnov8YnUURoZnv9t4iHjDyZkB9DZppYkqjHdLVmKYA-2Brg-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7Caebc0433c69048d954c408daf323d149%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638089632459923780%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=q3sR2y02b4FguyHsbT013%2B%2Bp97Q0Vs9DKIKVn0KZnnc%3D&reserved=0

  • REC name

    London - West London & GTAC Research Ethics Committee

  • REC reference

    21/PR/0578

  • Date of REC Opinion

    6 May 2021

  • REC opinion

    Favourable Opinion