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

Primary Purpose

Dehiscence Wound

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
ActiGraft
Sponsored by
RedDress Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dehiscence Wound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • Emek Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ActiGraft

Arm Description

Whole blood clot (WBC) gel

Outcomes

Primary Outcome Measures

Incidence of complete wound closure
Skin re-epithelialization without drainage or dressing requirements

Secondary Outcome Measures

Wound Percent Area Reduction (PAR)
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
Skin re-epithelialization without drainage or dressing requirements
Durability of wound closure 2 weeks after complete healing
No wound dehiscence
Comparison of time to complete closure between study cases and historic control
Skin re-epithelialization without drainage or dressing requirements

Full Information

First Posted
May 19, 2021
Last Updated
May 23, 2021
Sponsor
RedDress Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04899466
Brief Title
Efficacy Evaluation of ActiGraft in Secondary Closure of Abdominal Surgical Wound Dehiscence
Official Title
A Prospective Study Evaluating the Efficacy of ActiGraft in Secondary Closure of Abdominal Surgical Wound Dehiscence
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2021 (Anticipated)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RedDress Ltd.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dehiscence Wound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ActiGraft
Arm Type
Experimental
Arm Description
Whole blood clot (WBC) gel
Intervention Type
Device
Intervention Name(s)
ActiGraft
Intervention Description
Whole blood clot (WBC) gel
Primary Outcome Measure Information:
Title
Incidence of complete wound closure
Description
Skin re-epithelialization without drainage or dressing requirements
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Wound Percent Area Reduction (PAR)
Description
The change in wound area (decrease or increase) with respect to the area at baseline, expressed as a percentage.
Time Frame
2, 4 and 6 weeks
Title
Mean time of complete wound closure
Description
Skin re-epithelialization without drainage or dressing requirements
Time Frame
4 weeks
Title
Durability of wound closure 2 weeks after complete healing
Description
No wound dehiscence
Time Frame
Up to 6 weeks
Title
Comparison of time to complete closure between study cases and historic control
Description
Skin re-epithelialization without drainage or dressing requirements
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
Change in pain level
Description
Measured by Numeric Rating Scale (0 - no pain at all to 10 - worst pain) weekly for 4 weeks post ActiGraft application
Time Frame
1, 2, 3 and 4 weeks
Title
Patient satisfaction
Description
Will be assessed by subject satisfaction survey using a 5-point Likert Scale (the higher score means a better outcome).
Time Frame
1, 2, 3, 4, 6 weeks and 42 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sharon Sirota
Phone
+972545800765
Email
sharon@reddress.co.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Sirota
Organizational Affiliation
RedDress Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Emek Medical Center
City
Afula
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yifat Kadan, Dr. Med.
Phone
+972506943426
Email
yfat_ka@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Yifat Kadan, Dr. Med.

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The results will be part of several scientific publications
IPD Sharing Time Frame
Upon publication

Learn more about this trial

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

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