Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04880603
Other study ID # Restrata
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date April 5, 2021
Est. completion date April 25, 2022

Study information

Verified date May 2022
Source Nebraska Methodist Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Adult patients undergoing a radial forearm free flap or ulnar forearm free flap will be randomized to the use of the Restrata graft in combination with split-thickness skin graft for reconstruction. Photos will document whether the Restata graft aids in the healing.


Recruitment information / eligibility

Status Terminated
Enrollment 5
Est. completion date April 25, 2022
Est. primary completion date April 25, 2022
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - All patients age 19 or greater that will undergo radial forearm free flap or ulnar free flap. - Photo documentation of wound bed at two weeks and four weeks must be obtainable either by physician or patient. Exclusion Criteria: - Active systemic immunosuppression (active use of high-dose steroids (=40mg prednisone daily or equivalent) or other immunosuppressive medications OR medical conditions causing immunosuppression, i.e. human immunodeficiency virus etc). - Diabetes mellitus with most recent Hemoglobin A1c =10.0 within 30 days prior to surgery. - Morbid obesity (BMI >40). - Inability to maintain wrist immobilization for full planned period. - Severe malnutrition (prealbumin levels <10 mg per dL within 30 days prior to surgery OR BMI <15 (very severely underweight). - Other conditions felt to significantly impair wound healing per surgeon discretion

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Restrata Graft
Restrata will be meshed in a 1:2 fashion to allow for egress of serous fluid and minimize risk of fluid collection. Restrata will be applied to the entire wound bed not amenable to primary closure and will be underlaid beneath the surrounding skin edges. A split-thickness skin graft is harvested from patient's thigh at 15:1000 inches and placed on top of the Restrata to cover the entire wound bed. The graft is sutured in place using suture choice of surgeon's preference.
Procedure:
Standard of Care Skin Graft
Standard of Care Skin Graft

Locations

Country Name City State
United States Nebraska Methodist Hospital Omaha Nebraska

Sponsors (2)

Lead Sponsor Collaborator
Nebraska Methodist Health System Acera Surgical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tendon exposure Tendon exposure at four weeks post-operatively (Yes/No). 4 weeks post-operation
Primary Percentage of surface area Percentage of surface area of split-thickness skin graft incorporation at four weeks postoperatively. 4 weeks post operation
See also
  Status Clinical Trial Phase
Recruiting NCT05808920 - The RESCUE Study: Survival and Functional Outcomes Following Salvage Surgery for RESidual or reCurrent sqUamous cEll Carcinoma of the Head and Neck
Completed NCT02526017 - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Active, not recruiting NCT05060432 - Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT03997643 - Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Recruiting NCT04700475 - Effect of Low Level Laser Therapy on Prevention of Radiotherapy Induced Xerostomia in Cancer Patients. N/A
Withdrawn NCT04058145 - AMD3100 Plus Pembrolizumab in Immune Checkpoint Blockade Refractory Head and Neck Squamous Cell Carcinoma Phase 2
Completed NCT02572869 - Functional and Aesthetic Outcomes After Mandible Reconstruction With Fibula Osteomyocutaneous Free Flaps
Active, not recruiting NCT04474470 - A Study to Evaluate NT219 Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer Phase 1/Phase 2
Withdrawn NCT05073809 - Photoacoustic Imaging of Head and Neck Tumours
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Active, not recruiting NCT03651570 - Randomized Controlled Trial of a E-intervention to Help Patients Newly Diagnosed With Cancer Cope Better: Pilot Study N/A
Recruiting NCT04930432 - Study of MCLA-129, a Human Bispecific EGFR and cMet Antibody, in Patients With Advanced NSCLC and Other Solid Tumors Phase 1/Phase 2
Recruiting NCT06016699 - Immunological Function After Radiation With Either Proton or Photon Therapy
Terminated NCT03843554 - Commensal Oral Microbiota in Head and Neck Cancer N/A
Recruiting NCT05915572 - Mulligan Technique on Shoulder Dysfunction N/A
Completed NCT05897983 - Tens and Rocabado Exercises on TMJ Dysfunction N/A
Not yet recruiting NCT06289049 - Heavy Strength Training in Head and Neck Cancer Survivors Phase 2
Withdrawn NCT05263648 - Virtual Reality Software to Reduce Stress in Cancer Patients N/A
Withdrawn NCT03238638 - A Study of Epacadostat + Pembrolizumab in Head and Neck Cancer Patients, Who Failed Prior PD-1/PD-L1 Therapy Phase 2