Evaluating ActiGraft for healing abdominal surgical wounds
A Prospective Study Evaluating the Efficacy of ActiGraft in Secondary Closure of Abdominal Surgical Wound Dehiscence
This study is testing if a new treatment called ActiGraft can help women heal better from abdominal surgical wounds.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | RedDress Ltd. Industry-sponsored |
| Drugs / interventions | Prednisone |
| Locations | 1 site (Kfar Saba) |
| Trial ID | NCT04899466 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women over 18 who have experienced abdominal surgical wound dehiscence requiring secondary closure within three weeks of surgery.
Not a fit: Patients with necrotizing fasciitis, fascial dehiscence, or those currently on systemic steroids may not benefit from this study.
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 performed: While this approach is being evaluated in this specific context, similar studies using advanced wound care technologies have shown promise in improving healing outcomes.
Eligibility criteria
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 this trial is running
Kfar Saba
- Meir Medical Center — Kfar Saba, Israel (Recruiting)
Study contacts
- Study coordinator: Sharon Sirota
- Email: sharon@reddress.co.il
- Phone: +972545800765
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.