Efficacy Evaluation of ActiGraft in Secondary Closure of Abdominal Surgical Wound Dehiscence

NCT04899466 | Recruiting

• 1 other identifier: RD008
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Dehiscence Wound

Outcome Measures

Primary Outcomes (1)

• Incidence of complete wound closure

  Skin re-epithelialization without drainage or dressing requirements

  4 weeks

Secondary Outcomes (4)

• Wound Percent Area Reduction (PAR)

  2, 4 and 6 weeks

• Mean time of complete wound closure

  4 weeks

• Durability of wound closure 2 weeks after complete healing

  Up to 6 weeks

• Comparison of time to complete closure between study cases and historic control

  4 weeks

Other Outcomes (2)

• Change in pain level

  1, 2, 3 and 4 weeks

• Patient satisfaction

  1, 2, 3, 4, 6 weeks and 42 days

Study Arms (1)

ActiGraft

EXPERIMENTAL

Whole blood clot (WBC) gel

Device: ActiGraft

Interventions

ActiGraft DEVICE

Whole blood clot (WBC) gel

ActiGraft

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• RedDress Ltd.: lead

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

RECRUITING

Study Officials

• Sharon Sirota

  RedDress Ltd.

  STUDY DIRECTOR

Central Study Contacts

Sharon Sirota

CONTACT

+972545800765; sharon@reddress.co.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: May 24, 2021
• Study Start: August 1, 2021
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Upon publication

Locations

IL (1)