Clinical Studies

​KitoTech Medical has conducted clinical studies that have shown outstanding clinical results using microMend to close wounds in a broad range of clinical specialties including surgery, dermatology, and emergency medicine​.

 

In addition to these clinical studies, case studies have been conducted in several other specialties, including plastics, orthopedics, obstetrics, vascular surgery, and wound care.  Physicians have reported high levels of satisfaction with microMend and excellent results. 

 

 

A clinical study in 18 patients undergoing minimally invasive surgeries (laparoscopic or robotic) in General Surgery, Urology, and Gynecology. Please see attached study entitled “microMend Skin Closure Device – Clinical Study Comparing microMend to Sutures for Closing Port Site Wounds” for more detailed information. The study was also presented at the 2019 American College of Obstetrics Gynecology Meeting.

• Skin wounds at port sites closed with microMend were compared to those closed with sutures in the same patient. Evaluations took place at Day 0 (day of surgery) and Days 10 and 30 post-surgery. Eighty five percent (85%) of practitioners rated microMend superior to sutures in this study. Ninety percent (90%) of patients preferred microMend to sutures. 
• There were no serious or significant adverse events in the study. 

 

A single-arm clinical study was performed in 16 patients undergoing excisions of skin cancers and cysts in which microMend was used to close surgical incisions. The dermatologist in this study rated microMend excellent for overall and specific parameters (usability, speed, wound appearance) in every patient. Wound closure was 7x faster than what is reported for sutures in the literature. Please see attached study entitled “Clinical Study Using microMend to Close Skin Excisions and Mohs Surgeries”.

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Painless and Excellent Wound Closure and Cosmetic Results in Laceration Repair

 

A clinical study closing lacerations with microMend in 31 patients. Patients reported that the device was painless upon application, while wearing it and upon removal. Cosmetic results were superior to published reports with sutures and tissue adhesives. Doctors reported high levels of satisfaction with microMend. Please see attached abstract entitled "Evaluation of  microMend Wound Closure Device in Repairing Skin Lacerations".

Dermatologists Reported Major Advantages Regarding Speed, Usability and Cosmetic Results 

 

A clinical study has recently been completed in which microMend was used to close surgical wounds after Mohs Surgeries. A total of 10 wounds were treated in the study and the median ratings for microMend usability and speed and overall assessment were excellent as reported by the physician observer. Patients reported no pain or stress with the application of microMend. Outstanding cosmetic results were also reported in the study. Please see paper entitled "Closure of Skin Wounds with microMend Wound Closure Device after Mohs Surgery". The study has been submitted for publication.

 

Pre-clinical studies were performed using a standard wound closure model in pigs. Excellent wound closure and healing and cosmetic results were documented in all animals. In addition, tensile strength was equivalent between microMend and sutures. Please see "Pre-clinical Porcine Studies of Closure of Surgical Wounds".  

 

There have been no reported cases of significant adverse events in any patient which microMend has been used to date in clinical and case studies, as well as healthcare providers purchasing our product.  

 

KitoTech Medical plans to perform additional clinical studies that demonstrate the effectiveness of microMend in several other surgical and medical specialties.