Safety and Efficacy of WoundClot Surgical

NCT06696092 | Completed

• 1 other identifier: CSC-CAL-PRO-001
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Surgical Bleeding

Keywords

hemostat; hemostasis; WoundClot; bleeding

Outcome Measures

Primary Outcomes (1)

• Rate of clinically-successful hemostasis

  Proportion, in percent, of subjects with clinically-successful hemostasis at the target bleeding site within 5 minutes of applying WoundClot Surgical.

  Within 5 minutes of application of WoundClot Surgical

Secondary Outcomes (1)

• Time to hemostasis

  Within 5 minutes of application of WoundClot Surgical

Study Arms (1)

WoundClot Surgical

EXPERIMENTAL

If the pre- and intra-operative eligibility criteria are fulfilled, WoundClot Surgical will be applied to the index bleeding site and success in achieving hemostasis will be evaluated within 5 minutes following the application.

Device: Hemostatic Agent

Interventions

Hemostatic Agent DEVICE

WoundClot Surgical may be used in a single target bleeding site of each subject.

WoundClot Surgical

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pediatric, including newborn (from birth to 1 month of age), or adult (aged 80 or below) patient.
• Undergoing elective (non-emergency), open or laparoscopic soft tissue dissection, vascular, spinal, thyroid, breast, or gastrointestinal surgery, or hepatic resection.
• NOTE: for this study, soft tissue dissection may be part of:
• abdominoplasty, lower anterior resections, abdominal perineal resection, distal pancreatectomy, esophagectomy, skin graft donor site in burn patients, and mastectomy.
• Indicated for use of topical mechanical hemostat due to mild to moderate bleeding.
• Has not received transfusion of blood or blood products between screening and study intervention.
• Has a target bleeding site that is identifiable and has an approximate surface area of less than or equal to 100 cm\^2.
• Has last pre-study-intervention hematology and biochemistry values within the following limits:
• hemoglobin ≥ 8 g/dL (g/100 mL)
• platelets ≥ 150 x 10\^9/L (x 10\^3/mm\^3)
• white blood cells (WBC) ≥ 3.0 x 10\^9/L (x 10\^3/mm\^3)
• absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L (x 10\^/mm\^)
• serum creatinine \< 1.5 mg/dL
• aspartate aminotransferase (AST) \< 1.5 x ULN (upper limit of norm)
• alanine aminotransferase (ALT) \< 1.5 x ULN

You may not qualify if:

• If female and of child-bearing potential, has positive pregnancy test during screening and/or is breast-feeding.
• Participation in another interventional study.
• Febrile illness within 7 days of study intervention.
• History of coagulopathy or intra-procedural coagulopathy prior to study intervention.
• Intra-operative complications requiring resuscitation.
• Radiofrequency coagulation, other than focal radiofrequency ablation of vessels, of the target bleeding site prior to study intervention.
• Application of topical hemostat to the target bleeding site prior to study intervention.
• Known hypersensitivity to carboxymethyl cellulose or compounds containing it or its salts.
• In patients undergoing vascular surgery where heparin use is required, history of heparin-induced thrombocytopenia.
• Prisoners.

Sponsors & Collaborators

• Core Scientific Creations Ltd.: lead

Study Sites (8)

Spitalul Municipal Campina Sectia Clinica Chirurgie

Câmpina, Prahova, 105600, Romania

Location

Spitalul Sf. Constantin Brasov Sectia Chirurgie Generala

Brasov, 500299, Romania

Location

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

Bucharest, 010713, Romania

Location

Spitalul Clinic de Urgenta Bucuresti Secția Clinică Chirurgie III

Bucharest, 014451, Romania

Location

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

Bucharest, 041915, Romania

Location

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

Bucharest, 041915, Romania

Location

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

Bucharest, 041915, Romania

Location

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

Târgu Mureş, 540136, Romania

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 20, 2024
• Study Start: October 2, 2024
• Primary Completion: March 13, 2025
• Study Completion: May 8, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

RO (8)