Surgical BleedingWCS-1NCT06696092
Safety and Efficacy of WoundClot Surgical
A study testing Hemostatic Agent in people with Surgical Bleeding, run by Core Scientific Creations Ltd. at 8 sites in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Surgical Bleeding
- What is being tested?
- Hemostatic Agent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 8 sitesRomania
- Study dates
- 2 Oct 2024to 8 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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
- alkaline phosphatase (ALP) < 1.5 x ULN
- Willing and able to return for the required follow-up visits following study enrollment.
- If able to reproduce, agrees to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits when engaging in heterosexual intercourse.
- Signed informed consent.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Romania8 sites
Spitalul Sf. Constantin Brasov Sectia Chirurgie Generala
Brasov, 500299
Spitalul Clinic de Urgenta Chirurgie Plastica Reparatorie si Arsuri, Sectia Chirurgie Plastica Microchirugie Reconstructiva II
Bucharest, 010713
Spitalul Clinic de Urgenta Bucuresti Secția Clinică Chirurgie III
Bucharest, 014451
Spitalul Clinic de Urgență "Bagdasar Arseni" Bucuresti Secția Chirurgie Generala
Bucharest, 041915
Spitalul Clinic de Urgență "Bagdasar Arseni" Bucuresti Secția Chirurgie plastica si microchirurgie reconstructiva
Bucharest, 041915
Spitalul Clinic de Urgență "Bagdasar Arseni" Bucuresti Secția Neurochirurgie II
Bucharest, 041915
Spitalul Municipal Campina Sectia Clinica Chirurgie
Câmpina, Prahova, 105600
Spitalul Clinic de Urgenta Targu-Mures Clinica de Chirurgie si Ortopedie Pediatrica
Târgu Mureş, 540136
About this study
Official title: A Single Arm, Open Label, Multi-Center Study Evaluating the Efficacy and Safety of WoundClot Surgical
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.
Read the detailed 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.
- Conditions
- Surgical Bleeding
- Being tested
- Hemostatic Agent
- Keywords
- hemostat, hemostasis, WoundClot, bleeding
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemostatic AgentDevice
WoundClot Surgical may be used in a single target bleeding site of each subject.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Hemostatic Agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 5 minutes of application of WoundClot Surgical
Secondary outcomes (1)
Time to hemostasis
Time, in seconds, to clinically-successful hemostasis at the target bleeding site, from the treatment application start to the achievement or hemostasis.
Measured: Within 5 minutes of application of WoundClot Surgical
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start2 Oct 2024
- Primary completion13 Mar 2025
- Study completion8 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Core Scientific Creations Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06696092
- Sponsor's protocol ID
- CSC-CAL-PRO-001
- Acronym
- WCS-1
- Status last verified
- Jun 2025
- First submitted
- 18 Nov 2024
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Commercial study sponsor
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Open Label, Multi-Center Study Evaluating the Efficacy and Safety of WoundClot Surgical
- ClinicalTrials.gov ID
- NCT06696092
- Acronym / sponsor ID
- WCS-1 / CSC-CAL-PRO-001
- Conditions
- Surgical Bleeding
- Keywords
- hemostat, hemostasis, WoundClot, bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Core Scientific Creations Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- 13 Mar 2025 (actual)
- Study completion
- 8 May 2025 (actual)
- First posted
- 20 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WoundClot Surgical | Experimental | Device: Hemostatic AgentIf 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. |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (19 listed)
- 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.
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemostatic AgentWoundClot Surgical may be used in a single target bleeding site of each subject. | Device | WoundClot Surgical |
Primary outcome
Rate of clinically-successful hemostasis
Time frame: Within 5 minutes of application of WoundClot Surgical
Proportion, in percent, of subjects with clinically-successful hemostasis at the target bleeding site within 5 minutes of applying WoundClot Surgical.
1 secondary outcome
Time to hemostasis
Time frame: Within 5 minutes of application of WoundClot Surgical
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Individual participant dataSharing planned: No. Commercial study sponsor
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemostatic Agent in people with Surgical Bleeding, run by Core Scientific Creations Ltd. at 8 sites in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of clinically-successful hemostasis (time frame: Within 5 minutes of application of WoundClot Surgical). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025; AzTrials last refreshed its copy on 7 Nov 2026.