Clinical trial NCT02680106: Evaluation of the SPINNER Device for the Application of Wound Dressing: Treatment of Split Skin Graft Donor Sites
Official title: EVALUATION OF THE SPINNER™ DEVICE FOR THE APPLICATION OF WOUND DRESSING: TREATMENT OF SPLIT SKIN-GRAFT DONOR SITES. A Prospective, Safety and Efficacy, Open Labeled, Two Arms, Randomized, Multi Center, Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound of Skin
Keywords: Nanofibers
Dressing
Donor site
Polycaprolactone
Lead sponsor: Nicast Ltd.
Sponsor class: INDUSTRY
First posted: 2016-02-11
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of safety and performance of the SPINNER device and wound dressing in the treatment of donor-site wounds (DSW)

Detailed description: The SPINNER is a hand held, portable electro-spinning device that produces personalized in-situ nanofiber dressings for the treatment of external burns and wounds.

The dressing has non-adherence, high absorbance, bacterial protection, easy and pain-free peel characteristics and shows excellent conformability and optimal coverage of the wound.

The objective of this study is to evaluate the safety and performance of the SPINNER device and wound dressing in the treatment of donor-site wounds (DSW) at size of 10-200 cm2.

The study will include five sites in Israel:

Sheba Medical Center, Tel Hashomer RambamMedical Center, Haifa Kaplan Medical Center, Rehovot Souraski Medical Center, Tel Aviv Beilinson Medical Center, Petach Tikva

Study primary endpoints:

1. Dermal Safety
2. Wound healing and time to complete re-epithelialization at 1, 3, 5, 7, 14 and 21 days post operation

Study secondary endpoints:

1. Ease of use
2. Pain assessment at 1, 3, 5, 7, 14 and 21 days post operation
3. Infection assessment from 3 days post operation up to 21 days
4. Device related adverse events of the SPINNER device and wound dressing

Extended exploratory follow up:

Assessment of itching and scarring from wound closure time and up to 12 months follow up

Eligibility criteria: Inclusion Criteria:

* The patient is ≥ 18 years old at enrolment. Both genders.
* Patients with donor site wound, size of 10-200 cm2, located in the thigh after partial thickness skin-graft
* The patient is able and willing to comply with study procedures and give written informed consent prior to enrollment in the study

Exclusion Criteria:

* Any known or suspected systemic infection
* Any known sensitivity to components/products used in this study
* Use of penicillamine, corticosteroid or immunosuppressive medication within two months prior to enrollment, or current use of nonsteroidal anti- inflammatory agents which cannot be discontinued, or who is likely to be prescribed these medications or any other medications known to adversely affect wound healing during study participation
* Major uncontrolled systemic disorders such as hepatic, renal, neurologic, or endocrinologic disorders.
* Patients undergoing repeat skin graft harvesting at the same donor site
* Patients with burns of more than 15% TBSA
* Requires immersion hydrotherapy at any time during study participation
* Bleeding disorders
* Skin disorders such as psoriasis, pemphigus, Toxic Epidermal Necrolysis (TEN), Stevens-Johnson Syndrome (SJS), pyoderma gangrenosum and other exfoliative disorders
* Terminal patients
* Soldiers
* Prisoners
* Female patients who are pregnant or nursing, or of childbearing potential and are not using adequate contraception
* Participation in another clinical trial within 30 days prior to the Screening Visit or during this study.
* Psychiatric patient.

Primary outcomes:
measure: Change in dermal safety (Draize) score
timeFrame: 1-21 days
measure: Change in wound healing
timeFrame: 1-21 days
Secondary outcomes:
measure: Ease of use
timeFrame: 21 days
measure: Assessment of pain
timeFrame: 21 days
measure: Assessment of infection
timeFrame: 21 days
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Petach Tikva
country: Israel
facility: Beilinson Medical Center
city: Ramat Gan
country: Israel
facility: Burn Unit, Sheba Medical Center
city: Rehovot
country: Israel
facility: Kaplan Hospital
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Moti Harats, MD
role: PRINCIPAL_INVESTIGATOR
References: