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โ† Trials
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Efficacy Evaluation of ActiGraft in Secondary Closure of Abdominal Surgical Wound Dehiscence

RecruitingNAAges 18 Years - anyFemaleRedDress Ltd.
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In plain words

What the trial is, and whether it could suit you

This is a prospective, single arm study, consisting of 20 women with abdominal surgical wound dehiscence that requires secondary closure. The participants will receive a weekly application of ActiGraft for 4 weeks, or until complete healing of the wound (the earlier of the two). An historic matched-control group of 20 patients will be compared retrospectively

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age \>18 years * Women that had a laparotomy no more than 3 weeks before accrual. * Surgical wound dehiscence that requires a secondary closure. * Time from wound dehiscence \>24 hours and \<6 days. * The open wound includes epidermis, dermis and sub cutaneous fat. * The patient can sign an informed consent form. Exclusion Criteria: * Patients with necrotizing fasciitis * Patients with fascial dehiscence * Cannot withdraw blood in the required amount (up to 18 mL per week). * Known coagulation problems, abnormal thrombocytes level or if heparin is given intravenously. Subjects who are taking oral anti-coagulants or anti-agreganrts will not be excluded. * Pregnancy * Subject is currently receiving (i.e., within the past 30 days) or scheduled to receive systemic steroids (Prednisone- more than 10mg/d or equivalent).
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What it tests

  • ActiGraft
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Where

1 site
Meir Medical Center
Kfar Saba, Israel
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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