Safety and Efficacy of WoundClot Surgical

Last updated: June 25, 2025
Sponsor: Core Scientific Creations Ltd.
Overall Status: Completed

Phase

N/A

Condition

Hemorrhage

Treatment

Hemostatic Agent

Clinical Study ID

NCT06696092
CSC-CAL-PRO-001
  • Ages < 80
  • All Genders

Study Summary

The goal of this clinical trial is to verify that WoundClot Surgical helps stop bleedings which may occur during surgery. It will also help learn more about the safety of WoundClot Surgical. The main questions this clinical trial aims to answer are:

What is the rate at which WoundClot Surgical helps resolve bleeding after it is applied to a site of a bleeding during surgery? How long does it take from the moment WoundClot Surgical is applied to a site of a bleeding during surgery until the bleeding is resolved? What medical problems do participants have if WoundClot Surgical is applied to a site of a bleeding during surgery?

There is a single treatment group in this study and, if a participant is enrolled (ie, gives consent to participate, meets all conditions for study entry, and experiences a bleeding during the surgery), WoundClot Surgical will be applied to the site of bleeding. The enrolled participants will also need to visit the clinic 8 weeks (± 3 days) after the surgery for checkups.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Pediatric, including newborn (from birth to 1 month of age), or adult (aged 80 orbelow) patient.

  2. Undergoing elective (non-emergency), open or laparoscopic soft tissue dissection,vascular, spinal, thyroid, breast, or gastrointestinal surgery, or hepaticresection. NOTE: for this study, soft tissue dissection may be part of: abdominoplasty, lower anterior resections, abdominal perineal resection, distalpancreatectomy, esophagectomy, skin graft donor site in burn patients, andmastectomy.

  3. Indicated for use of topical mechanical hemostat due to mild to moderate bleeding.

  4. Has not received transfusion of blood or blood products between screening and studyintervention.

  5. Has a target bleeding site that is identifiable and has an approximate surface areaof less than or equal to 100 cm^2.

  6. Has last pre-study-intervention hematology and biochemistry values within thefollowing limits:

  7. hemoglobin ≥ 8 g/dL (g/100 mL)

  8. platelets ≥ 150 x 10^9/L (x 10^3/mm^3)

  9. white blood cells (WBC) ≥ 3.0 x 10^9/L (x 10^3/mm^3)

  10. absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (x 10^/mm^)

  11. serum creatinine < 1.5 mg/dL

  12. aspartate aminotransferase (AST) < 1.5 x ULN (upper limit of norm)

  13. alanine aminotransferase (ALT) < 1.5 x ULN

  14. alkaline phosphatase (ALP) < 1.5 x ULN

  15. Willing and able to return for the required follow-up visits following studyenrollment.

  16. If able to reproduce, agrees to use a medically accepted form of contraception fromthe time of consent to completion of all follow-up study visits when engaging inheterosexual intercourse.

  17. Signed informed consent.

Exclusion

Exclusion Criteria:

  1. If female and of child-bearing potential, has positive pregnancy test duringscreening and/or is breast-feeding.

  2. Participation in another interventional study.

  3. Febrile illness within 7 days of study intervention.

  4. History of coagulopathy or intra-procedural coagulopathy prior to studyintervention.

  5. Intra-operative complications requiring resuscitation.

  6. Radiofrequency coagulation, other than focal radiofrequency ablation of vessels, ofthe target bleeding site prior to study intervention.

  7. Application of topical hemostat to the target bleeding site prior to studyintervention.

  8. Known hypersensitivity to carboxymethyl cellulose or compounds containing it or itssalts.

  9. In patients undergoing vascular surgery where heparin use is required, history ofheparin-induced thrombocytopenia.

  10. Prisoners.

Study Design

Total Participants: 72
Treatment Group(s): 1
Primary Treatment: Hemostatic Agent
Phase:
Study Start date:
October 02, 2024
Estimated Completion Date:
May 08, 2025

Study Description

Following provision of consent, the prospective subjects will be screened for eligibility to participate in the study (Visit 1). Screening procedures and evaluations will include laboratory analyses of complete blood count, serum chemistry, coagulation parameters, and a pregnancy test. Medical history and concomitant medications will be recorded. A physical examination will be conducted, and vital signs will be taken.

Once initial eligibility is confirmed, subjects will be scheduled for the procedure for which they are indicated (Visit 2). If the intra-operative eligibility criteria are fulfilled, WoundClot Surgical will be used (study intervention). Time to hemostasis and any additional surgical and non-surgical intervention(s) or reintervention(s), for persistent or recurrent bleeding, respectively, will be recorded.

Two follow-up visits will be conducted, as part of the planned protocol procedures - on the day after the procedure (Visit 3; if the subject is released from the facility on the same day, this Visit will be conducted prior to the release) and 8 weeks ± 3 days after the procedure (Visit 4; last study Visit). Any additional intervention(s) or reintervention(s) for recurrent bleeding and complications of the initial intervention, whether deemed related to the study intervention (device and/or procedure) or not, will be recorded during every study Visit, planned or unscheduled, starting after Visit 2.

Administration of blood products at any time after the study intervention and before end of study will be captured.

Any device deficiencies and any adverse events, whether deemed related to the study device and/or procedure or not, will be recorded at every study Visit, planned or unscheduled.

Connect with a study center

  • Spitalul Municipal Campina Sectia Clinica Chirurgie

    Campina, Prahova 105600
    Romania

    Site Not Available

  • Spitalul Sf. Constantin Brasov Sectia Chirurgie Generala

    Brasov, 500299
    Romania

    Site Not Available

  • Spitalul Clinic de Urgenta Bucuresti Secția Clinică Chirurgie III

    Bucharest, 014451
    Romania

    Site Not Available

  • Spitalul Clinic de Urgenta Chirurgie Plastica Reparatorie si Arsuri, Sectia Chirurgie Plastica Microchirugie Reconstructiva II

    Bucharest, 010713
    Romania

    Site Not Available

  • Spitalul Clinic de Urgență "Bagdasar Arseni" Bucuresti Secția Chirurgie Generala

    Bucharest, 041915
    Romania

    Site Not Available

  • Spitalul Clinic de Urgență "Bagdasar Arseni" Bucuresti Secția Chirurgie plastica si microchirurgie reconstructiva

    Bucharest, 041915
    Romania

    Site Not Available

  • Spitalul Clinic de Urgență "Bagdasar Arseni" Bucuresti Secția Neurochirurgie II

    Bucharest, 041915
    Romania

    Site Not Available

  • Spitalul Clinic de Urgenta Targu-Mures Clinica de Chirurgie si Ortopedie Pediatrica

    Targu-Mures, 540136
    Romania

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.