Efficacy Evaluation of ActiGraft in Secondary Closure of... | NCT04899466

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

NCT04899466

Sponsor

RedDress Ltd.

Status

Recruiting

Last Update Posted

Nov 15, 2024Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Dehiscence Wound

Interventions

ActiGraft

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2021Actual

Primary Completion Date

Aug 1, 2026Estimated

Completion Date

Aug 1, 2026Estimated

First Submitted Date

May 19, 2021

First Submission Date that Met QC Criteria

May 19, 2021

First Posted Date

May 24, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 13, 2024

Last Update Posted Date

Nov 15, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ActiGraft	Experimental	Whole blood clot (WBC) gel	Device: ActiGraft

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ActiGraft	Device	Whole blood clot (WBC) gel	ActiGraft

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

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).

Eligibility Module

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).

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sharon Sirota	Contact	+972545800765		sharon@reddress.co.il

Overall Officials

Name	Affiliation	Role
Sharon Sirota	RedDress Ltd.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Meir Medical Center	Recruiting	Kfar Saba			Israel

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

The results will be part of several scientific publications

Types

Study Protocol

Time Frame

Upon publication

Access Criteria

Not provided

URL

Not provided