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

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

Study Overview

• Status: Recruiting
• Conditions: Dehiscence Wound
• Intervention / Treatment: Device: ActiGraft

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sharon Sirota; Phone Number: +972545800765; Email: sharon@reddress.co.il

Study Locations

• Israel
  • Kfar Saba, Israel
    • Recruiting
    • Meir Medical Center
    • Contact: Asia Kaizler; Phone Number: +972506943426; Email: asia.kaizler@clalit.org.il
    • Principal Investigator: Zvi Klein, Dr. Med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ActiGraft; Whole blood clot (WBC) gel	Device: ActiGraft; Whole blood clot (WBC) gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of complete wound closure	Skin re-epithelialization without drainage or dressing requirements	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Percent Area Reduction (PAR)	The change in wound area (decrease or increase) with respect to the area at baseline, expressed as a percentage.	2, 4 and 6 weeks
Mean time of complete wound closure	Skin re-epithelialization without drainage or dressing requirements	4 weeks
Durability of wound closure 2 weeks after complete healing	No wound dehiscence	Up to 6 weeks
Comparison of time to complete closure between study cases and historic control	Skin re-epithelialization without drainage or dressing requirements	4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain level	Measured by Numeric Rating Scale (0 - no pain at all to 10 - worst pain) weekly for 4 weeks post ActiGraft application	1, 2, 3 and 4 weeks
Patient satisfaction	Will be assessed by subject satisfaction survey using a 5-point Likert Scale (the higher score means a better outcome).	1, 2, 3, 4, 6 weeks and 42 days

Collaborators and Investigators

• Sponsor: RedDress Ltd.
• Investigators: Study Director: Sharon Sirota, RedDress Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: May 19, 2021
• First Submitted That Met QC Criteria: May 19, 2021
• First Posted (Actual): May 24, 2021

Study Record Updates

• Last Update Posted (Actual): November 15, 2024
• Last Update Submitted That Met QC Criteria: November 13, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Surgical Wound; Wounds and Injuries; Surgical Wound Dehiscence
• Other Study ID Numbers: RD008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The results will be part of several scientific publications
• IPD Sharing Time Frame: Upon publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No