Dehiscence Wound
Conditions
Brief summary
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
Interventions
DEVICEActiGraft
Whole blood clot (WBC) gel
Sponsors
RedDress Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of complete wound closure | 4 weeks | Skin re-epithelialization without drainage or dressing requirements |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound Percent Area Reduction (PAR) | 2, 4 and 6 weeks | The change in wound area (decrease or increase) with respect to the area at baseline, expressed as a percentage. |
| Mean time of complete wound closure | 4 weeks | Skin re-epithelialization without drainage or dressing requirements |
| Durability of wound closure 2 weeks after complete healing | Up to 6 weeks | No wound dehiscence |
| Comparison of time to complete closure between study cases and historic control | 4 weeks | Skin re-epithelialization without drainage or dressing requirements |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in pain level | 1, 2, 3 and 4 weeks | Measured by Numeric Rating Scale (0 - no pain at all to 10 - worst pain) weekly for 4 weeks post ActiGraft application |
| Patient satisfaction | 1, 2, 3, 4, 6 weeks and 42 days | Will be assessed by subject satisfaction survey using a 5-point Likert Scale (the higher score means a better outcome). |
Countries
Israel
Contacts
Primary ContactSharon Sirota
Outcome results
None listed