Clinical Evidence

Clinical Evidence

DermaClip across peer reviewed studies cover emergency medicine, military medicine, obstetrics, and geriatric care. The studies below were conducted at Army medical centers, VA hospitals, and academic medical institutions - and span randomized controlled trials, prospective pilot studies, and peer-reviewed case reports.

6x Faster than sutures - 77 sec vs. 456 sec (83% faster) in randomized crossover trial (p<0.001)
100% Level 1 healing rate in 120-patient randomized trial - zero adverse events
53% Faster C-section closure vs. subcuticular sutures in randomized pilot study (p<0.0001)
<90 sec Closure of 7.5cm laceration on anticoagulated elderly patient - no anesthesia

Peer-Reviewed Publications & Clinical Presentations

A Recent Advance in the Closure of Skin Wounds on Fragile Skin

Case Reports in Emergency Medicine · Volume 2021 · Hindawi (Open Access)

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Clinical Case Report

A peer-reviewed case report documenting successful DermaClip closure on two elderly patients with fragile skin presenting to the emergency department with traumatic lacerations. Published under Creative Commons Attribution License.

Authors: John Ko, MD, PhD, FACS & Jeffrey S. Freed, MD, MPH, FACS, FACG - Icahn School of Medicine at Mount Sinai

Patient 1 - 79-Year-Old Female, Anticoagulated (Heart Valve Replacement)

7.5cm crescent-shaped full-thickness laceration, dorsum of hand. Wound bleeding and untreated for over 24 hours prior to presentation. Closed with 5 Regular DermaClip devices in under 90 seconds. No anesthesia used. Scar imperceptible at 41-week follow-up.

Patient 2 - 84-Year-Old Female, Multiple Myeloma on Anticoagulants, Long-Term Corticosteroids

Two traumatic lacerations: 7.6cm primary + 2.4cm secondary. Wound continued to ooze after closure - DermaClip maintained closure where tissue adhesives would have failed. Total closure time 10 minutes including wound cleaning. No anesthesia used. Scar imperceptible at 22-week follow-up.

DermaClip fragile skin closure results - Day 1 vs Day 135 - Patient 1, 79-year-old female, anticoagulated, 7.5cm laceration closed with no anesthesia

Patient 1 - Day 1 (closure with 5 Regular DermaClip devices) vs. Day 135 (healed). 79-year-old anticoagulated female, 7.5cm laceration, no anesthesia used. Published in Case Reports in Emergency Medicine, 2021.

Closes Wounds That Continue to Ooze Patient 2's wound continued to bleed after closure. DermaClip maintained secure closure - a scenario where tissue adhesives are contraindicated and would have failed.
No Anesthesia in Either Case Both patients - including one anticoagulated with a wound bleeding for 24+ hours - were closed without local anesthetic. Neither experienced discomfort during closure.
Cost Advantage vs. Tissue Adhesives DermaClip closes wounds at $3.67/cm vs. $4.80/cm for tissue adhesives - and extends effectiveness to wounds over 5cm and wounds with active oozing where TSAs cannot be used.
Imperceptible Scarring Both patients achieved cosmetically excellent results with essentially imperceptible scarring at long-term follow-up (22 and 41 weeks), despite extremely fragile, compromised skin.
Ko J, Freed JS. Case Reports in Emergency Medicine. 2021;Article ID 6687961. doi:10.1155/2021/6687961 Download Full Paper (PDF)

Non-Invasive Skin Closure Device (DermaClip) vs. Conventional Sutures: A Prospective Randomized Crossover Trial on Cadaver Models

SOMA Annual Conference · May 2025 · Raleigh, NC · Darnall Emergency Medicine, Carl R. Darnall Army Medical Center, Fort Cavazos, TX

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Conference Presentation & Doctoral Thesis

A prospective randomized crossover trial conducted at Carl R. Darnall Army Medical Center comparing DermaClip to conventional sutures for laceration repair. Twenty military medical personnel performed 40 repairs (20 per method) on cadaver models. Presented at the SOMA Annual Conference in May 2025 and accepted as a doctoral thesis.

Author: CPT Jessica A. Martin, PA-C - Department of Emergency Medicine, Carl R. Darnall Army Medical Center, Fort Cavazos, TX. Additional investigators: LTC Jerimiah Walker DSc PA-C, CPT Matthew Perdue DSc PA-C, CPT Clifford Sandoval DSc PA-C, MAJ Rachel Rodriguez DSc PA-C, COL Christopher Mitchell MD.

83% Faster Than Sutures DermaClip average closure time: 77 seconds vs. 456 seconds for conventional sutures — a statistically significant difference (p<0.001). The most dramatic speed advantage demonstrated across all DermaClip studies to date.
Outscored Sutures in Every Category DermaClip was rated higher than sutures in confidence and efficacy across every evaluated category. 85% of participants rated confidence in DermaClip vs. 65% for sutures at study completion.
Provider Confidence Improved Post-Study Pre-study provider confidence in DermaClip: 30%. Post-study: 95% (p<0.00046). Results suggest DermaClip's potential as a rapid training tool for military medics and corpsmen with varying skill levels.
Combat Readiness Implications Study authors conclude DermaClip may enhance combat readiness and patient outcomes as the military shifts toward large-scale combat operations (LSCO) - particularly for personnel with limited suturing training.
Publication status: Presented at the SOMA Annual Conference, May 2025, and accepted as a doctoral thesis. Peer-reviewed publication pending.
Martin JA, Walker J, Perdue M, et al. Presented at SOMA Annual Conference, May 5-9, 2025, Raleigh, NC. Darnall Emergency Medicine, Carl R. Darnall Army Medical Center. Download Presentation (PDF)

An Innovative Advance in Non-invasive Wound Closure: A New Paradigm

Military Medicine · Vol. 183, March/April Supplement 2018 · Oxford University Press

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Randomized Controlled Trial

A 120-patient randomized, parallel-controlled clinical trial evaluating DermaClip against a standard wound closure device. Conducted across two hospitals, including the Army 254th Hospital. Originally presented as an oral presentation at the 2016 Military Health System Research Symposium and subsequently published in Military Medicine, the official journal of the Association of Military Surgeons of the United States.

Authors: Jeffrey S. Freed, MD, MPH, FACS, FACG & John Ko, MD, PhD, FACS - Icahn School of Medicine at Mount Sinai / James J. Peters VA Medical Center

100% Level 1 Healing Rate Both the DermaClip group and the control group achieved 100% Level 1 healing - defined as "initial healing excellent without any adverse reaction" - across all 120 patients.
Zero Adverse Events No skin allergies, no wound infections, and no adverse reactions in either group across the full study period.
Equivalent Postoperative Outcomes 98.33% "Excellent" postoperative care ratings in both groups. No statistically significant difference in ease of use, scar results, or postoperative outcomes between DermaClip and the control device.
Field & Emergency Applicability Authors conclude DermaClip is particularly applicable to emergency and battlefield settings - no anesthesia required, applicable by any trained provider, and usable at night without suturing skill.
Freed JS, Ko J. Military Medicine. 2018;183(suppl_1):472-480. doi:10.1093/milmed/usx165 Download Full Paper (PDF)

Evaluation of a Novel Skin Closure Device at the Time of Cesarean Section: A Randomized Pilot Study

The Journal of Reproductive Medicine · Vol. 64 · 2019

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Randomized Pilot Study

A prospective, IRB-approved randomized pilot study of 32 patients undergoing cesarean section, comparing DermaClip skin closure to subcuticular suture closure. Conducted at a major east coast teaching hospital and published in The Journal of Reproductive Medicine.

Authors: Robert J. Rubino, MD, FACOG & Charbel G. Salamon, MD, FACOG, FACS

53% Faster Closure Time DermaClip closure averaged 3 minutes 15 seconds vs. 6 minutes 57 seconds for subcuticular sutures (p<0.0001) - a statistically significant reduction in operative skin closure time.
Prospective Randomized Design 32 patients randomized with no significant differences in age, race, or BMI between groups. IRB-approved with informed consent. Primary outcome: operative skin closure time.
Surgical Suite Application Demonstrates DermaClip's effectiveness in a controlled surgical environment - extending its clinical utility beyond emergency and trauma settings into elective operative closure.
Referenced in Military Medicine 2018 This study is cited in the Freed/Ko Military Medicine paper (citation 20), establishing DermaClip's cross-specialty evidence base spanning surgical, emergency, and military applications.
Abstract only available for download. Full text available through The Journal of Reproductive Medicine.
Rubino RJ, Salamon CG. Journal of Reproductive Medicine. 2019;64:193-196. Download Abstract (PDF)

Published & Presented Across Multiple Specialties

DermaClip's clinical evidence spans emergency medicine, military medicine, obstetrics, and geriatric care - with studies conducted at U.S. Army medical centers, VA hospitals, and academic medical institutions.

Emergency Medicine Fragile skin, skin tears, geriatric lacerations
Military Medicine Field use, combat settings, LSCO readiness
Obstetrics / OB C-section closure, operative time reduction
Mount Sinai & Army Icahn School of Medicine + Darnall Army Medical Center