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CompletedNCT03783039Updated Jul 8, 2021Results posted

The SURGICEL® Powder Mild or Moderate Parenchymal or Soft Tissue Intraoperative Bleeding (China Study)

An interventional study of SURGICEL Powder and SURGICEL Original in Hemorrhage, sponsored by Ethicon, LLC. Completed at 6 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-08.

Sponsored by Ethicon, LLC · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
234
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a single blind, randomized, prospective study comparing SURGICEL Powder with SURGICEL Original (control arm) as an adjunct to achieve hemostasis in the control of capillary, venous, and small arterial hemorrhage when ligation or other conventional methods of control are impractical or ineffective during surgery (open, laparoscopic, or thoracoscopic) in Chinese adult subjects.

Read the detailed description

This is a single blind, randomized, prospective study comparing SURGICEL Powder with SURGICEL Original (control arm) as an adjunct to achieve hemostasis in the control of capillary, venous, and small arterial hemorrhage when ligation or other conventional methods of control are impractical or ineffective during surgery (open, laparoscopic, or thoracoscopic) in Chinese adult subjects.

After application of either SURGICEL Powder or SURGICEL Original, the target bleeding site (TBS) will be assessed for hemostasis (no detectable bleeding) at 3, 5, and 10 minutes from application and prior to initiation of final fascial closure on open surgery or port site closure in laparoscopic or thoracoscopic procedures.

All enrolled subjects will be observed post-operatively through discharge and followed up at 30 days (+14 days) and at 6 months (+/-30 days) post-surgery via phone call or office visit.

02

Conditions studied

  • Hemorrhage

Keywords

  • bleeding
  • broad area oozing bleeding
  • hemostat
  • topical hemostatic agents
  • adjunctive hemostats
03

In context

Hemorrhage

3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.

This study's enrollment of 234 is above the median of 100 across 1,985 interventional studies indexed under Hemorrhage.

Browse Hemorrhage studies →

Lead sponsor

This is the only study on the registry with Ethicon, LLC as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Adult subjects aged ≥18 years requiring elective/non-emergent open or laparoscopic general, gynecological, or cardiothoracic surgical procedures.
  2. Subject or authorized representative has signed the approved Informed Consent.
  3. Subject(s) whose platelet count is ≥100,000 per microliter and International Normalized Ratio (INR) is \<1.5 prior to 24 hours of surgery.
  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

Exclusion Criteria:

  1. Female subjects who are pregnant or nursing.
  2. Subject on heparin within 12 hours prior to surgery, or oral Coumadin (warfarin) and/or Factor Xa inhibitors within 3 days prior to surgery.
  3. Subject on antiplatelet/P2Y12 inhibitors medication 5 days prior to surgery;
  4. Subject is currently participating or plans to participate in any other investigational product or drug trial 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.
  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 1).
  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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
234 participants (actual)

Study arms

  • Experimental
    SURGICEL Powder

    SURGICEL Powder is an absorbable hemostat that is oxidized regenerated cellulose in a powder form

    Device: SURGICEL Powder

  • Active comparator
    SURGICEL Original

    SURGICEL Original is an bsorbable hemostat that is oxidized regenerated cellulose in a fabric form

    Device: SURGICEL Original

Interventions

  • DeviceSURGICEL Powder

    Surgeon to perform surgical procedure according to standard of care. If randomized to SURGICEL Powder, the product will be be applied to the first appropriate TBS with mild or moderate bleeding in parenchyma or soft tissue where conventional methods of control (i.e. suture, ligature, cautery) are ineffective or impractical.

  • DeviceSURGICEL Original

    Surgeon to perform surgical procedure according to standard of care. If randomized to SURGICEL Original, the product will be be applied to the first appropriate TBS with mild or moderate bleeding in parenchyma or soft tissue where conventional methods of control (i.e. suture, ligature, cautery) are ineffective or impractical.

06

What researchers measure

Primary outcomes

  1. Hemostatic Success at 5 Minutes

    Percentage of subjects achieving hemostatic success at 5 minutes following study product application with no rebleeding requiring additional treatment at the Target Bleeding Site (TBS) any time prior to initiation of final fascial closure

    Time frame: From product application to 5 minutes following product application

Secondary outcomes

  1. Hemostatic Success at 3 Minutes

    Percentage of subjects achieving hemostatic success at 3 minutes following study product application with no rebleeding requiring additional treatment at the TBS any time prior to initiation of final fascial closure

    Time frame: From product application to 3 minutes following product application

  2. Hemostatic Success at 10 Minutes

    Percentage of subjects achieving hemostatic success at 10 minutes following study product application with no rebleeding requiring additional treatment at the TBS any time prior to initiation of final fascial closure

    Time frame: From product application to 10 minutes following product application

Other outcomes

  1. Number of Participants With Thromboembolic Events

    Number of participants with thrombotic events assessed as unlikely, possibly, probably or related to the study treatment

    Time frame: From enrollment to 30-day follow-up visit

  2. Number of Participants With Post-operative Re-bleeding Events

    Number of participants with post-operative re-bleeding events assessed as unlikely, possibly, probably or related to study treatment and requiring medical/surgical intervention

    Time frame: From initiation of final fascial closure to 30-day follow-up visit

  3. Number of Participants With Serious Adverse Events Requiring Surgical Intervention

    Number of Participants with Serious Adverse Events requiring surgical intervention and assessed as being unlikely, possibly, probably or related to study treatment

    Time frame: From enrollment to 6 month follow up visit

07

Results

Posted Dec 22, 2020

Participant flow

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.

Participant flow — Overall Study
MilestoneSURGICEL PowderSURGICEL Original
Started119115
Completed117114
Not completed21
Withdrew: Death21

Outcome measures

PrimaryHemostatic Success at 5 Minutes

Percentage of subjects achieving hemostatic success at 5 minutes following study product application with no rebleeding requiring additional treatment at the Target Bleeding Site (TBS) any time prior to initiation of final fascial closure

Time frame:
From product application to 5 minutes following product application
Reported as:
Count of participants · Participants
Hemostatic Success at 5 Minutes
ParticipantsSURGICEL PowderSURGICEL Original
Hemostatic Success at 5 Minutes109103
Statistical analysis
  • SURGICEL Powder vs SURGICEL Original · Farrington-Manning method · p = <0.0001 (Testing whether the group difference in proportion of successes is \>-0.1 (Test Group - Control Group)) · Risk difference (rd): 0.0605
SecondaryHemostatic Success at 3 Minutes

Percentage of subjects achieving hemostatic success at 3 minutes following study product application with no rebleeding requiring additional treatment at the TBS any time prior to initiation of final fascial closure

Time frame:
From product application to 3 minutes following product application
Reported as:
Count of participants · Participants
Hemostatic Success at 3 Minutes
ParticipantsSURGICEL PowderSURGICEL Original
Hemostatic Success at 3 Minutes10792
Statistical analysis
  • SURGICEL Powder vs SURGICEL Original · Farrington-Manning Method · Difference in proportion of successes: 0.0992 · 95.0% CI 0.0078 to 0.1906Difference in proportion of successes (Test Group - Control Group)
SecondaryHemostatic Success at 10 Minutes

Percentage of subjects achieving hemostatic success at 10 minutes following study product application with no rebleeding requiring additional treatment at the TBS any time prior to initiation of final fascial closure

Time frame:
From product application to 10 minutes following product application
Reported as:
Count of participants · Participants
Hemostatic Success at 10 Minutes
ParticipantsSURGICEL PowderSURGICEL Original
Hemostatic Success at 10 Minutes114107
Statistical analysis
  • SURGICEL Powder vs SURGICEL Original · Farrington-Manning Method · Difference in proportion of successes: 0.0275 · 95% CI -0.0312 to 0.0863Difference in proportion of successes (Test Group - Control Group)
Other pre-specifiedNumber of Participants With Thromboembolic Events

Number of participants with thrombotic events assessed as unlikely, possibly, probably or related to the study treatment

Time frame:
From enrollment to 30-day follow-up visit
Reported as:
Count of participants · Participants
Number of Participants With Thromboembolic Events
ParticipantsSURGICEL PowderSURGICEL Original
Investigator Assessment00
Sponsor Assessment00
Other pre-specifiedNumber of Participants With Post-operative Re-bleeding Events

Number of participants with post-operative re-bleeding events assessed as unlikely, possibly, probably or related to study treatment and requiring medical/surgical intervention

Time frame:
From initiation of final fascial closure to 30-day follow-up visit
Reported as:
Count of participants · Participants
Number of Participants With Post-operative Re-bleeding Events
ParticipantsSURGICEL PowderSURGICEL Original
Investigator Assessment11
Sponsor Assessment10
Other pre-specifiedNumber of Participants With Serious Adverse Events Requiring Surgical Intervention

Number of Participants with Serious Adverse Events requiring surgical intervention and assessed as being unlikely, possibly, probably or related to study treatment

Time frame:
From enrollment to 6 month follow up visit
Reported as:
Count of participants · Participants
Number of Participants With Serious Adverse Events Requiring Surgical Intervention
ParticipantsSURGICEL PowderSURGICEL Original
Number of Participants With Serious Adverse Events Requiring Surgical Intervention00

Adverse events

Collected over All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
SURGICEL Powder2/119 (1.7%)9/119 (7.6%)83/119 (69.7%)
SURGICEL Original1/115 (0.9%)5/115 (4.3%)80/115 (69.6%)
Most frequent serious events
Showing 10 of 20
Most frequent serious events
EventSURGICEL PowderSURGICEL Original
Peritoneal HemorrhageGastrointestinal disorders0/1191/115
Pulmonary Air LeakageRespiratory, thoracic and mediastinal disorders1/1191/115
PneumothoraxRespiratory, thoracic and mediastinal disorders0/1191/115
Anastomotic FistulaInjury, poisoning and procedural complications0/1191/115
Post Procedural Bile LeakInjury, poisoning and procedural complications0/1191/115
Liver AbscessInfections and infestations0/1191/115
Cerebral InfarctionNervous system disorders0/1191/115
Shock HemorrhagicVascular disorders0/1191/115
Abdominal PainGastrointestinal disorders1/1190/115
Gastrointestinal HemorrhageGastrointestinal disorders1/1190/115
Most frequent other events
Showing 10 of 108
Most frequent other events
EventSURGICEL PowderSURGICEL Original
Incision Site PainInjury, poisoning and procedural complications33/11926/115
Acute Phase ReactionGeneral disorders14/11912/115
PyrexiaGeneral disorders7/1199/115
HypokalaemiaMetabolism and nutrition disorders9/1196/115
HypoproteinaemiaMetabolism and nutrition disorders9/1195/115
ConstipationGastrointestinal disorders4/1198/115
White Blood Cell Count IncreasedInvestigations4/1198/115
VomitingGastrointestinal disorders8/1196/115
Abdominal PainGastrointestinal disorders7/1193/115
NauseaGastrointestinal disorders7/1194/115

Baseline characteristics

Age, Continuous
Age, Continuous(Years)SURGICEL PowderSURGICEL OriginalTotal
Median54.0 (20 to 96)52.0 (23 to 89)53.0 (20 to 96)
Sex: Female, Male
Sex: Female, Male(Participants)SURGICEL PowderSURGICEL OriginalTotal
Female7773150
Male424284
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)SURGICEL PowderSURGICEL OriginalTotal
Han116114230
Other314
08

Study locations

6 sites
  • Zhejiang Provincial People's Hospital
    Hangzhou, China
  • Jiangsu Province Hospital
    Nanjing, China
  • Nanjing Drum Tower Hospital - Nanjing University Medical School
    Nanjing, China
  • Ruijin Hospital - Shanghai Jiaotong University School of Medicine
    Shanghai, China
  • Shanghai Xinhua Hospital
    Shanghai, China
  • The Affiliated Hospital of Xuzhou Medical University
    Xuzhou, China
09

References and documents

Study documents

  • Study protocol · Sep 3, 2019
  • Statistical analysis plan · Jul 24, 2020

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03783039
Lead sponsor
Ethicon, LLC
Responsible party
Sponsor
First posted
Dec 20, 2018
Start date
Jan 15, 2019
Primary completion
Dec 3, 2019
Completion
May 6, 2020
Results posted
Dec 22, 2020
Last update
Jul 8, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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