- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03586960
Use of a Novel Device for Stretch Relaxation During Mohs Surgery
Closure of cutaneous defects is associated with many common and serious problems. For example, Mohs surgery involves the removal of skin and other soft tissues that have been proven to be infiltrated with cancer. Iterative stages of Mohs are processed and examined microscopically for residual tumor. Using specialized mapping, the surgeon can effectively achieve a high cure rate and minimize removal of unaffected tissue. This process usually takes a total of 2-3 hours, since the patient waits while the tissue is being processed, and complete clearance of margins can take multiple stages. In many cases, a cutaneous defect is produced of significant size. In certain areas of high tension, such as scalp and lower leg, this mandates either a lengthy course of wound care or that the surgeon perform a graft or flap. In many cases, performance of a graft is undesirable due to lack of vascularity to support graft survival. Creation of flaps involves incision and undermining of large areas of tissue in order to achieve wound closure. There is a current need for alternatives to graft and flaps in these locations.
Human skin has biomechanical properties that can be harnessed to facilitate closure of larger wounds. Stress-relaxation refers to the natural relaxation exhibited by skin put under a given amount of tension (stress) over time. After a period of stress, the force required to close the wound is reduced. In a porcine skin wound model, there is a 40-60% reduction in stress after twenty minutes of stretch relaxation.
There are several classic methods of delivering this stretch to skin intraoperatively. Most simply, a towel clamp can be used to bring edges together. However, the clamp, which is a sharp stainless steel instrument, can damage tissues. There are also commercial devices such as TopClosure. However, this device is intended for very large wounds with side plates that must be sutured or stapled to patient skin.
The SUTUREGARD device presents a simple method to provide stress to a wound but not damage tissue. The SUTUREGARD device results in significantly lower pressure on the skin when compared with traditional sutures and creates a much greater volume of wound eversion than is possible with a traditional suturing method. Engineering tests performed at OSU showed that a given simple interrupted suture will exert about 30% less pressure on the skin when used performed with the device compared to without the device. With this protection, this creates the corollary that a suture could be safely tied to a greater force with the device than without. In animal testing, the device has been used on porcine wounds for up to 6 weeks, where it showed superior histologic tolerability over traditional sutures.
The investigators have used the device to provide stress-relaxation within our clinic over the past several months and have seen reductions in wound width of about 30% with retention of the device for 30-60 minutes. Wounds exhibit significantly more reduction in width with overnight use. Unlike traditional retention sutures, which damage the skin, the skin appears normal with retention of the device for up to 2 days in our patients. Furthermore, all wounds that have been stress-relaxed with the device have healed without complication.
The investigators plan to study the stress-relaxation created by use of a SUTUREGARD device applied to cutaneous defects for a specified time periods (30, 60 and 90 minutes).
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oregon
-
Salem, Oregon, United States, 97302
- Recruiting
- Silver Falls Dermtology
-
Contact:
- Angie Tingle
- Phone Number: 503-362-8385
- Email: atingle@silverfallsderm.net
-
Sub-Investigator:
- Allie Melkonian, DO
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Any wound that cannot be reapproximated upon tumor removal (These locations are often on the lower leg and scalp.)
- Age over 18 years
- Intact skin surrounding wound for at least 2.5 cm
Exclusion Criteria:
- Active infection
- Systemically unstable or unwell patient
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Experimental Group
Peak tension will be measured with a calibrated force gauge (Series 3 Digital Force Gauge; Mark-10 Corporation; Copiague, NY) until the wound edges touch.
A clamp will be used to secure the sutures on top of the device between measurements.
At each time point (5, 10 and 30 minutes), the clamps will be loosened and the wound allowed to relax.
Photographs and measurements will be taken to document the wound size after stress-reduction.
The suture will be re-tensioned while measurements of peak tension (as outlined above) are recorded with the force gauge.
|
Force will be measured at 5,10, and 30 minutes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Direct measurements of wound dimensions at each timepoint
Time Frame: 5 minutes
|
Measurements will be taken at each time point of wound size
|
5 minutes
|
Direct measurements of wound dimensions at each timepoint
Time Frame: 10 minutes
|
Measurements will be taken at each time point of wound size
|
10 minutes
|
Direct measurements of wound dimensions at each timepoint
Time Frame: 30 minutes
|
Measurements will be taken at each time point of wound size
|
30 minutes
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Saqib NU, Domenick N, Cho JS, Marone L, Leers S, Makaroun MS, Chaer RA. Predictors and outcomes of restenosis following tibial artery endovascular interventions for critical limb ischemia. J Vasc Surg. 2013 Mar;57(3):692-9. doi: 10.1016/j.jvs.2012.08.115. Epub 2013 Jan 23.
- Townsend KL, Akeroyd J, Russell DS, Kruzic JJ, Robertson BL, Lear W. Comparing the Tolerability of a Novel Wound Closure Device Using a Porcine Wound Model. Adv Wound Care (New Rochelle). 2018 Jun 1;7(6):177-184. doi: 10.1089/wound.2017.0777.
- Topaz M, Carmel NN, Topaz G, Li M, Li YZ. Stress-relaxation and tension relief system for immediate primary closure of large and huge soft tissue defects: an old-new concept: new concept for direct closure of large defects. Medicine (Baltimore). 2014 Dec;93(28):e234. doi: 10.1097/MD.0000000000000234.
- Hussain SH, Limthongkul B, Humphreys TR. The biomechanical properties of the skin. Dermatol Surg. 2013 Feb;39(2):193-203. doi: 10.1111/dsu.12095. Epub 2013 Jan 25.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB18-025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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