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SNaP Wound Care System Over Skin Cancer Excision Sites and Split Thickness Skin Grafts (STSGs)

Post-Market Clinical Evaluation of the Spiracur SNaP™ Wound Care System for Treatment of Skin Cancer Excision Sites and Split Thickness Skin Grafts

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01349894
Enrollment
0
Registered
2011-05-09
Start date
2011-08-31
Completion date
2012-06-30
Last updated
2024-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Cancer Excision Site, Skin Graft, Split Thickness Skin Graft

Brief summary

The purpose of this study is to evaluate the efficacy of the Spiracur SNaP® Wound Care System for the treatment of skin cancer excision sites and split thickness skin grafts (STSG). The secondary purpose will be to compare the prospective patients to retrospectively treated skin cancer excision sites and STSGs to further evaluate efficacy and safety.

Interventions

Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.

Sponsors

3M
CollaboratorINDUSTRY
Solventum US LLC
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Skin cancer excision site and/or STSG as the source of the wound on any part of the body including head and neck, torso, and extremities. Any other type of skin graft will also be eligible for inclusion into the study. * Wound \< 16 cm in greatest diameter * Subject ≥ 18 years of age * Female subjects of child-bearing potential must be willing to take a urine pregnancy test prior to starting study * Subject is willing and able to sign informed consent

Exclusion criteria

* Wound-related cellulitis * Wound located in an area not amenable to forming an air-tight seal * Subject has untreated osteomyelitis * Subject is allergic to wound care products * Wound has exposed blood vessels not suitable for negative pressure therapy * Subject is actively participating in other clinical trials that conflict with current study * Subject has fistulas * Subject is pregnant

Design outcomes

Primary

MeasureTime frame
Wound Closure12 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026