Evaluating ActiGraft for healing abdominal surgical wounds
Official title: A Prospective Study Evaluating the Efficacy of ActiGraft in Secondary Closure of Abdominal Surgical Wound Dehiscence
Run by RedDress Ltd. · NCT04899466 · Data updated 2026-11-12
This study is testing if a new treatment called ActiGraft can help women heal better from abdominal surgical wounds.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 20 (estimated) |
| Sponsor | RedDress Ltd. Industry-sponsored |
| Drugs / interventions | Prednisone |
| Locations | 1 site (Kfar Saba) |
| Status | Recruiting |
| Started | August 1, 2021 |
| Main results expected | August 1, 2026 |
| Study ends | August 1, 2026 |
| Registry record updated | November 15, 2024 |
| Trial ID | NCT04899466 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women over 18 who have experienced abdominal surgical wound dehiscence requiring secondary closure within three weeks of surgery.
✕Probably not a fit
Patients with necrotizing fasciitis, fascial dehiscence, or those currently on systemic steroids may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of ActiGraft in promoting the healing of abdominal surgical wound dehiscence in women. It involves a prospective, single-arm approach with 20 participants who will receive weekly applications of ActiGraft for up to four weeks or until their wounds heal. The outcomes will be compared to a historic matched-control group of 20 patients to assess the efficacy of the treatment. The study aims to provide insights into the potential benefits of ActiGraft in wound management.
Why it matters
Potential benefit: If successful, this treatment could significantly improve healing rates for women with abdominal surgical wound dehiscence.
How similar studies have gone: While this approach is being evaluated in this specific context, similar studies using advanced wound care technologies have shown promise in improving healing outcomes.
Who can join: the full rules
Show full inclusion / exclusion criteria
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).
Where it's running
-
Meir Medical Center
Kfar Saba, Israel Recruiting
Study contacts
- Study coordinator: Sharon Sirota
- Email: sharon@reddress.co.il
- Phone: +972545800765
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Evaluating RD2 Ver.02 for managing anal fistulas
This study is testing a new treatment called RD2 Ver.02 to see if it can help people with certain types of anal fistulas heal better than a saline solution.
-
Evaluating ActiGraft for treating cutaneous wounds
This study is testing if ActiGraft can help heal different types of wounds, like diabetic foot ulcers and pressure sores, in real-life situations.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.