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NCT Number: NCT04899466

Efficacy Evaluation 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

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Key information

Conditions

Dehiscence Wound

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Meir Medical Center

Kfar Saba, Israel

Location status: Recruiting

Location contact

Asia Kaizler

CONTACT

[email protected]

+972506943426

Zvi Klein, Dr. Med.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

ActiGraft

Device

Whole blood clot (WBC) gel

Primary outcomes

  1. Incidence of complete wound closure

    Time frame: 4 weeks

    Skin re-epithelialization without drainage or dressing requirements

Secondary outcomes

  1. Wound Percent Area Reduction (PAR)

    Time frame: 2, 4 and 6 weeks

    The change in wound area (decrease or increase) with respect to the area at baseline, expressed as a percentage.

  2. Mean time of complete wound closure

    Time frame: 4 weeks

    Skin re-epithelialization without drainage or dressing requirements

  3. Durability of wound closure 2 weeks after complete healing

    Time frame: Up to 6 weeks

    No wound dehiscence

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

    Time frame: 4 weeks

    Skin re-epithelialization without drainage or dressing requirements

Other outcomes

  1. Change in pain level

    Time frame: 1, 2, 3 and 4 weeks

    Measured by Numeric Rating Scale (0 - no pain at all to 10 - worst pain) weekly for 4 weeks post ActiGraft application

  2. Patient satisfaction

    Time frame: 1, 2, 3, 4, 6 weeks and 42 days

    Will be assessed by subject satisfaction survey using a 5-point Likert Scale (the higher score means a better outcome).

Study contacts

Contact information is provided by the study sponsor or research team.

Sharon Sirota

CONTACT

[email protected]

+972545800765

Sponsors and collaborators

Lead sponsor

RedDress Ltd.

Industry

Registry information

Official study title

A Prospective Study Evaluating the Efficacy of ActiGraft in Secondary Closure of Abdominal Surgical Wound Dehiscence

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
May 24, 2021
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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