Hemorrhage
Conditions
Keywords
bleeding, broad area oozing bleeding, hemostat, topical hemostatic agents, adjunctive hemostats
Brief summary
This is a prospective, single arm, multicentre, multispecialty, post market, clinical study evaluating SURGICEL Powder as an adjunct to achieve haemostasis (control bleeding) when conventional methods of control are impractical or ineffective during surgery (open, laparoscopic or thoracoscopic) in adult subjects (18 years or older). After application of SURGICEL Powder, the Target Bleeding Site (TBS) will be assessed for haemostasis (no detectable bleeding) at 3, 5, and 10 minutes from application and prior to initiation of closure. All enrolled subjects will be followed post-operatively through discharge and again at 30 days and 6 months post-surgery via phone call or office visit.
Detailed description
This is an open label, prospective, single arm, multicentre, multispecialty, post-marketing clinical study evaluating SURGICEL Powder as an adjunct to achieve haemostasis in the control of capillary, venous, and small arterial haemorrhage when ligation or other conventional methods of control are impractical or ineffective during surgery (open, laparoscopic or thoracoscopic) in adult subjects (18 years or older). Prospective subjects will be informed about the nature of the research, given the informed consent form (ICF) to read, and, if he/she understands the content, will be asked to provide consent by signing the ICF. Screening and enrolment will continue until at least 100 evaluable subjects from approximately eight (8) investigational sites, with an appropriate mild or moderate Target Bleeding Site (TBS) are included into the study. The TBS will be the only region evaluated for the primary endpoint and all secondary effectiveness endpoints. All enrolled subjects will be followed post-operatively through discharge, and via phone call or office visit at 30 days (+14 days) post-surgery. In addition, all enrolled subjects will receive a 6-month (+/-30 days) follow-up phone call or office visit to assess the occurrence of any serious adverse event (SAE) requiring surgical intervention and assessed as possibly related or related to the study treatment.
Interventions
DEVICESURGICEL Powder
SURGICEL Powder is a topical absorbable hemostatic treatment made of oxidized regenerated cellulose (ORC) - plant material
Sponsors
Ethicon, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Pre-operative: 1. Adult subjects ≥ 18 years requiring elective/non-emergent open or laparoscopic general, gynaecological, cardiothoracic, or urological surgical procedures; 2. Subject or authorised representative has signed the approved Informed Consent; 3. Subject(s) whose International Normalised Ratio is \<1.5 within 24 hours of surgery. Intra-operative: 4. Presence of an appropriate TBS identified intra-operatively by the surgeon; 5. Subject(s) undergoing cardiothoracic surgery with anticoagulation must have anticoagulation reversed prior to TBS identification and treatment.
Exclusion criteria
Pre-operative: 1. Female subjects who are pregnant or nursing; 2. Subject on anticoagulation medication (with exception of aspirin) prior to surgery. Washout periods for respective medications must be observed. If information is not readily available within the Instructions for Use (IFU), a conservative approach should be taken and intravenous heparin stopped 12 hours prior to surgery and 2 days prior for oral medication; 3. Subject on antiplatelet/P2Y12 inhibitors medication prior to surgery. Platelet recovery times for respective medication must be observed. If information is not readily available within the IFU, a conservative approach should be taken and medication stopped 5 days prior to surgery. 4. Subject is currently participating or plans to participate in any other investigational device or drug without prior approval from the Sponsor; 5. Subjects who are known, current alcohol and/or drug abusers; 6. Subjects with any pre-operative findings identified by the surgeon that may preclude conduct of the study procedure. Intra-operative: 7. Subjects with any intra-operative findings identified by the surgeon that may preclude the use of study product; 8. Subject with TBS in an actively infected field \[Class III Contaminated or Class IV Dirty or Infected (see Appendix 2 in in Section 15.2)\]; 9. TBS is on arteries or veins where application of SURGICEL Powder would present a risk of introducing the study product into an open blood vessel; 10. Major arterial or venous bleeding or major defects in arteries and veins; 11. TBS where silver nitrate or any other escharotic chemicals have been applied; 12. TBS is in, around, or in proximity to foramina in bone, or areas of bony confine, the spinal cord, or optic nerve and chiasm; 13. TBS in urological procedures where plugging (blocking) of the urethra, ureter or a catheter is possible by the study product.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Haemostatic Success at 5 Minutes | From application of SURGICEL Powder to 5 minutes after application | Proportion of subjects achieving haemostatic success at 5 minutes following application of SURGICEL Powder with no rebleeding requiring additional treatment at the Target Bleeding Site (TBS) any time prior to initiation of final fascial closure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Haemostatic Success at 3 Minutes | From application of SURGICEL Powder to 3 minutes after application | Proportion of subjects achieving haemostatic success at 3 minutes following application of SURGICEL Powder with no rebleeding requiring additional treatment at the TBS any time prior to initiation of final fascial closure |
| Haemostatic Success at 10 Minutes | From application of SURGICEL Powder to 10 minutes after application | Proportion of subjects achieving haemostatic success at 10 minutes following the application of SURGICEL Powder with no rebleeding that requires additional treatment at the TBS any time prior to initiation of final fascial closure |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing a Thromboembolic Event | From application of SURGICEL Powder to 30 day follow-up visit | Number of participants experiencing a thromboembolic event that was assessed as having either an unlikely, possible, probable or causal relationship to the study treatment |
| Number of Participants With Post-operative Re-bleeding | From initiation of final fascial closure to the 30-day follow up visit | Number of participants of post-operative re-bleeding that was assessed as having either an unlikely, possible, probable or causal relationship to the TBS and requiring medical/surgical intervention |
| Number of Participants Experiencing a Serious Adverse Events Requiring Surgical Intervention and Related to SURGICEL Powder | From time of SURGICEL Powder application to 6-month follow up visit | Number of participants experiencing a serious adverse event requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment |
Countries
Belgium, United Kingdom
Participant flow
Recruitment details
Subjects were screened up to 21 days prior to surgery and attended a baseline visit within 24 hours of surgery. Both visits took place at a clinic within the hospital where surgery also took place. Subjects were followed until hospital discharge and requested to attend a visit at 30 (+14) days post surgery and at 6 months (+/- 30 days) either at the hospital or via telephone.
Pre-assignment details
Subjects required to meet pre-defined inclusion/exclusion criteria prior to receiving study product. Subjects required to have an appropriate mild or moderate target bleeding site (TBS) identified intra-operatively. Subjects excluded if the TBS was where silver nitrate or any other escharotic chemicals were applied, was in, around, or in proximity to foramina in bone, areas of bony confine or where plugging of the urethra, ureter or a catheter was possible by study product.
Participants by arm
| Arm | Count |
|---|---|
| SURGICEL Powder Absorbable Haemostatic Powder (Oxidized Regenerated Cellulose) | 103 |
| Total | 103 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 2 |
Baseline characteristics
| Characteristic | SURGICEL Powder |
|---|---|
| Age, Continuous Age at Consent | 64.0 Years |
| Race/Ethnicity, Customized Race : Asian | 2 Participants |
| Race/Ethnicity, Customized Race : Not Reported | 8 Participants |
| Race/Ethnicity, Customized Race : White | 93 Participants |
| Sex: Female, Male Female | 51 Participants |
| Sex: Female, Male Male | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 103 |
| other Total, other adverse events | 63 / 103 |
| serious Total, serious adverse events | 24 / 103 |
Outcome results
Primary
Haemostatic Success at 5 Minutes
Proportion of subjects achieving haemostatic success at 5 minutes following application of SURGICEL Powder with no rebleeding requiring additional treatment at the Target Bleeding Site (TBS) any time prior to initiation of final fascial closure
Time frame: From application of SURGICEL Powder to 5 minutes after application
Population: Intent to Treat (All subjects for whom TBS was identified)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SURGICEL Powder | Haemostatic Success at 5 Minutes | 90 Participants |
95% CI: [79.4, 93.1]
Secondary
Haemostatic Success at 10 Minutes
Proportion of subjects achieving haemostatic success at 10 minutes following the application of SURGICEL Powder with no rebleeding that requires additional treatment at the TBS any time prior to initiation of final fascial closure
Time frame: From application of SURGICEL Powder to 10 minutes after application
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SURGICEL Powder | Haemostatic Success at 10 Minutes | 95 Participants |
95% CI: [85.3, 96.6]
Secondary
Haemostatic Success at 3 Minutes
Proportion of subjects achieving haemostatic success at 3 minutes following application of SURGICEL Powder with no rebleeding requiring additional treatment at the TBS any time prior to initiation of final fascial closure
Time frame: From application of SURGICEL Powder to 3 minutes after application
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SURGICEL Powder | Haemostatic Success at 3 Minutes | 80 Participants |
95% CI: [68.4, 85.3]
Other Pre-specified
Number of Participants Experiencing a Serious Adverse Events Requiring Surgical Intervention and Related to SURGICEL Powder
Number of participants experiencing a serious adverse event requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment
Time frame: From time of SURGICEL Powder application to 6-month follow up visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SURGICEL Powder | Number of Participants Experiencing a Serious Adverse Events Requiring Surgical Intervention and Related to SURGICEL Powder | 0 Participants |
Other Pre-specified
Number of Participants Experiencing a Thromboembolic Event
Number of participants experiencing a thromboembolic event that was assessed as having either an unlikely, possible, probable or causal relationship to the study treatment
Time frame: From application of SURGICEL Powder to 30 day follow-up visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SURGICEL Powder | Number of Participants Experiencing a Thromboembolic Event | 0 Participants |
Other Pre-specified
Number of Participants With Post-operative Re-bleeding
Number of participants of post-operative re-bleeding that was assessed as having either an unlikely, possible, probable or causal relationship to the TBS and requiring medical/surgical intervention
Time frame: From initiation of final fascial closure to the 30-day follow up visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SURGICEL Powder | Number of Participants With Post-operative Re-bleeding | 0 Participants |