Dehiscence WoundNCT04899466
Efficacy Evaluation of ActiGraft in Secondary Closure of Abdominal Surgical Wound Dehiscence
A study testing ActiGraft in people with Dehiscence Wound, run by RedDress Ltd. at 1 site in Israel.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Dehiscence Wound
- What is being tested?
- ActiGraft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Aug 2021to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Meir Medical Center
Kfar Saba
Asia Kaizler, +972506943426, asia.kaizler@clalit.org.il
Zvi Klein, Dr. Med.
About this study
Official title: A Prospective Study Evaluating the Efficacy of ActiGraft in Secondary Closure of Abdominal Surgical Wound Dehiscence
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
- Conditions
- Dehiscence Wound
- Being tested
- ActiGraft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActiGraftDevice
Whole blood clot (WBC) gel
| Study group | Role | What they receive |
|---|---|---|
| ActiGraft | Experimental | Whole blood clot (WBC) gel Receives: Device: ActiGraft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of complete wound closure
Skin re-epithelialization without drainage or dressing requirements
Measured: 4 weeks
Secondary outcomes (4)
Wound Percent Area Reduction (PAR)
The change in wound area (decrease or increase) with respect to the area at baseline, expressed as a percentage.
Measured: 2, 4 and 6 weeks
Mean time of complete wound closure
Skin re-epithelialization without drainage or dressing requirements
Measured: 4 weeks
Durability of wound closure 2 weeks after complete healing
No wound dehiscence
Measured: Up to 6 weeks
Comparison of time to complete closure between study cases and historic control
Skin re-epithelialization without drainage or dressing requirements
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start1 Aug 2021
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dehiscence WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RedDress Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sharon Sirota, Study director, RedDress Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04899466
- Sponsor's protocol ID
- RD008
- Status last verified
- Nov 2024
- First submitted
- 19 May 2021
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The results will be part of several scientific publications
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study Evaluating the Efficacy of ActiGraft in Secondary Closure of Abdominal Surgical Wound Dehiscence
- ClinicalTrials.gov ID
- NCT04899466
- Acronym / sponsor ID
- RD008
- Conditions
- Dehiscence Wound
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- RedDress Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 24 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ActiGraft | Experimental | Device: ActiGraftWhole blood clot (WBC) gel |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ActiGraftWhole blood clot (WBC) gel | Device | ActiGraft |
Primary outcome
Incidence of complete wound closure
Time frame: 4 weeks
Skin re-epithelialization without drainage or dressing requirements
4 secondary outcomes
Wound Percent Area Reduction (PAR)
Time frame: 2, 4 and 6 weeks
Mean time of complete wound closure
Time frame: 4 weeks
Durability of wound closure 2 weeks after complete healing
Time frame: Up to 6 weeks
Comparison of time to complete closure between study cases and historic control
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Individual participant dataSharing planned: Yes. The results will be part of several scientific publications
Related trials for Dehiscence Wound
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Not yet recruitingPhase 2
Early Feeding TL Trial
Total Laryngectomy
Not yet recruitingObservational study
Arterial Stiffness During Negative Pressure Wound Therapy for Abdominal Wall Wounds
Postoperative Abdominal Wall Wound Complications, Surgical Wound Infection
Not yet recruiting
Comparative Study of Regional Nerve Blocks in Primary Cleft Palate Repair
Cleft Lip, Cleft Palate +/- Lip
Not yet recruiting
Knotless Versus Conventional Sutures for Wound Closure in Cerebral Palsy Multilevel Surgery
Cerebral Palsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sharon Sirota study director
RedDress Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ActiGraft in people with Dehiscence Wound, run by RedDress Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sharon Sirota (+972545800765, sharon@reddress.co.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of complete wound closure (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.