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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2026-08-01

Brief Summary

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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

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Detailed Description

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Conditions

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Dehiscence Wound

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ActiGraft

Whole blood clot (WBC) gel

Group Type EXPERIMENTAL

ActiGraft

Intervention Type DEVICE

Whole blood clot (WBC) gel

Interventions

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ActiGraft

Whole blood clot (WBC) gel

Intervention Type DEVICE

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No