CClinicalTrials.gg
TerminatedNCT01831596Updated Nov 25, 2024Results posted

Evaluation of a Novel Post-Surgical Dressing

An interventional study of ciSNaP in Post Surgical Wound, sponsored by KCI USA, Inc. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-25.

Sponsored by KCI USA, Inc · Not applicable, Interventional, and Treatment

Why this study was terminated
The study was terminated by Spiracur. Efforts were made to contact the PI/study team members, but were unsuccessful.

From the registry’s dates

  • Registered 2 years 5 months after the study started (first participant enrolled Nov 2010, registered Apr 2013).
Phase
Not applicable
Study type
Interventional
Enrollment
59
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate the safety and efficacy of the Closed-Incision SNaP Device.

02

Conditions studied

  • Post Surgical Wound

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03

In context

Surgical Wound

519 studies on the registry are indexed under Surgical Wound; 71 are open to participants now.

This study's enrollment of 59 is below the median of 80 across 412 interventional studies indexed under Surgical Wound.

Browse Surgical Wound studies →

Lead sponsor

KCI USA, Inc is the lead sponsor of 17 studies on the registry; none are open to participants now.

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

  • Surgically closed incision.
  • Subject is 18 years of age or older.
  • Subject consents to follow-up per protocol.
  • Willing and able to sign informed consent.

Exclusion criteria

Exclusion Criteria:

  • Subject is allergic to wound care products used in this study.
  • Subject has wounds with exposed blood vessels not suitable for negative pressure therapy.
  • Pregnant or pregnancy-suspected subject.
  • Subject actively participating in other clinical trials that conflict with the current study.
  • Subject is unable or unwilling to comply with protocol requirements.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
59 participants (actual)

Study arms

  • Experimental
    ciSNaP

    Device: ciSNaP

Interventions

  • DeviceciSNaP

    SNaP disposable, mechanically powered Negative Pressure Wound Therapy System

06

What researchers measure

Primary outcomes

  1. Frequency of Complaints About Device Use and Operation

    Frequency of complaints about device use and operation

    Time frame: 30 days

07

Results

Posted Sep 28, 2020

Participant flow

Participant flow — Overall Study
MilestoneciSNaP
Started59
Completed51
Not completed8
Withdrew: Other8

Outcome measures

PrimaryFrequency of Complaints About Device Use and Operation

Frequency of complaints about device use and operation

Time frame:
30 days

No measurements were reported for this outcome.

Adverse events

Collected over 30 Days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
ciSNaP0/51 (0%)0/51 (0%)6/51 (11.8%)
Most frequent other events
Most frequent other events
EventciSNaP
Stitch granulomaSkin and subcutaneous tissue disorders3/51
Minor dehiscenceSkin and subcutaneous tissue disorders3/51
BlisterSkin and subcutaneous tissue disorders2/51
Mild surgical infectionInfections and infestations2/51
Congestive Heart Failure exacerbationCardiac disorders1/51
HemarthrosisBlood and lymphatic system disorders1/51
LymphoceleBlood and lymphatic system disorders1/51

Baseline characteristics

Age, Continuous
Age, Continuous(years)ciSNaP
Mean68 ± 11.8
Sex: Female, Male
Sex: Female, Male(Participants)ciSNaP
Female18
Male33
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)ciSNaP
Ethnicity (White)41
Ethnicity (Non-White)10
Region of Enrollment
Region of Enrollment(Participants)ciSNaP
United States51
08

Study locations

1 site
  • El Camino Hospital
    Mountain View, California 94040, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01831596
Lead sponsor
KCI USA, Inc
Collaborators
3M
Responsible party
Sponsor
First posted
Apr 15, 2013
Start date
Nov 2010
Primary completion
Jun 2012
Completion
Jun 2012
Results posted
Sep 28, 2020
Last update
Nov 25, 2024

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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