Clinical Trials Logo

Clinical Trial Summary

Fasciotomy wounds are rarely able to be closed at the time of index surgery. They often require multiple returns to surgery for closure, and occasionally require skin grafting (i.e. they are never completely closed). We are interested in seeing whether this device, which provides constant and gradual tension on the wound, may allow for rapid wound closure in a safe fashion, perhaps even precluding a return trip to surgery.

Null hypothesis #1: The Dermaclose Wound Management System (Woundcare Technologies Inc, Chanhassen, Minnesota) will not result in closure of fasciotomy wounds more rapidly than standard vessel loop techniques.

Null hypothesis #2: The Dermaclose Wound Management System will not reduce the number of return trips to the operating room for surgical procedures related to closure or skin grafting of fasciotomy wounds.


Clinical Trial Description

After IRB approval, all patients meeting inclusion criteria and requiring fasciotomy of the arms, legs, or pelvis will be consented for participation in the research study. Patients will either have their fasciotomy wounds closed through application of the Dermaclose device, as per the manufacturer's instructions, or through application of vessel loops with staples in a "shoestring technique" as described in the literature (1). Choice of wound closure technique will be at surgeon discretion. All patients will undergo application of a vacuum-assisted wound closure device (Wound VAC, Active Healing Solutions Inc, San Antonio, TX), which is standard of care for temporary coverage of open wounds (2, 3). Patients will be returned to the operating room every 2-3 days until wound closure or skin grafting has been accomplished. If skin closure is not accomplished in the operating room, but occurs prior to return trip to the operating room, then definitive suture closure of the wound will be performed under local anaesthetic, followed by removal of the Dermaclose device or of the vessel loop with staple shoestring. Decisions regarding wound closure or skin grafting in the operating room will be left to the judgment of the attending surgeon. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01171534
Study type Interventional
Source University of Missouri-Columbia
Contact
Status Terminated
Phase N/A
Start date July 2010
Completion date February 2014

See also
  Status Clinical Trial Phase
Recruiting NCT04554212 - Blood Flow Restriction Training After Patellar INStability N/A
Suspended NCT02932176 - Machine Learning for Handheld Vascular Studies
Recruiting NCT04803253 - Study of the Social and Professional Reintegration Improvements Using a Set of Solutions for Upper Limb Amputation N/A
Completed NCT00116337 - Spinal Cord Stimulation to Restore Cough N/A
Completed NCT03463720 - Outcome for Patients With War-Associated Extremity Wound Infection N/A
Completed NCT03113253 - TRANexamic Acid to Reduce Bleeding in BURN Surgery Phase 4
Not yet recruiting NCT05492903 - COMmunity of Practice And Safety Support for Navigating Pain (COMPASS-NP) N/A
Terminated NCT02909231 - One-year Patient Reported Outcomes Following Hospitalization for Trauma N/A
Completed NCT02432456 - Ketamine Infusion Therapy for the Management of Acute Pain in Adult Rib Fracture Patients Phase 4
Completed NCT02266771 - Impact of V.A.C. Veraflo Therapy in Wounds Requiring Debridement Within an Orthopedic Practice N/A
Completed NCT02744144 - Wound Bacterial Microbiota and Their Antibiotic Resistance N/A
Completed NCT02394821 - Odor Management in Fungating Wounds Comparing Metronidazole and Polihexanide Phase 3
Not yet recruiting NCT01665963 - Efficacy of TopClosure(C)System in Healing Complicated Pacemaker Wounds N/A
Completed NCT00151112 - Comparison of Two Different Procedures for Plexus Anesthesia N/A
Not yet recruiting NCT03872544 - Short Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
Recruiting NCT04596124 - Effectiveness and Tolerability of Fitostimoline Plus Cream and Gauze vs Connettivina Bio Plus Cream and Gauze N/A
Recruiting NCT05800834 - Benefits of Morphine Gel for Pain Reduction in Patients With Cancer Wounds Phase 2
Enrolling by invitation NCT03880188 - Long Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
Terminated NCT04775316 - Prospective, International, Multicenter, Observational Study to Evaluate the Clinical Performance and Safety of a Silicone-coated Transparent Postoperative Dressing
Enrolling by invitation NCT03312504 - Implementing a School Prevention Program to Reduce Injuries Through Neuromuscular Training N/A