Use of a Novel Device for Stretch Relaxation During Mohs Surgery

Mohs Surgery Clinical Trial

Official title:

Use of a Novel Device for Stretch Relaxation During Mohs Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03586960
• Other study ID #: IRB18-025
• Status: Recruiting
• Phase: N/A
• Start date: July 2, 2018
• Est. completion date: September 30, 2018

Study information

• Verified date: July 2018
• Source: Silver Falls Dermatology
• Contact: Angie Tingle
• Phone: 503 362 8385
• Email: atingle[@]silverfallsderm.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 30, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mohs Surgery
• Stress Strain Curve
• Tissue Expander Disorder
• Tissue Expansion

Intervention

Device:
• Peak Force Measurement
Force will be measured at 5,10, and 30 minutes

Locations

Country	Name	City	State
United States	Silver Falls Dermtology	Salem	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Silver Falls Dermatology

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Direct measurements of wound dimensions at each timepoint	Measurements will be taken at each time point of wound size	5 minutes
Primary	Direct measurements of wound dimensions at each timepoint	Measurements will be taken at each time point of wound size	10 minutes
Primary	Direct measurements of wound dimensions at each timepoint	Measurements will be taken at each time point of wound size	30 minutes