Post Approval Study to Evaluate the Safety and Efficacy of Gentafoil Resorb

Study Overview
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Brief Summary
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Single arm study to evaluate the safety and efficacy of Genta-Foil resorb® for the prevention of tissue adhesions

Official Title
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Post Approval Study to Evaluate the Safety and Efficacy of Gentafoil Resorb for the Prevention of Tissue Adhesions.

Conditions
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Tissue Adhesions, Surgery-Induced

Intervention / Treatment
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* Device: Genta-Foil resorb


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is male or female, ≥18 years of age; Subject is willing and able to give written informed consent; Subject is willing and able to comply with the protocol assessments at time of surgery and during the post-surgical follow up period Exclusion Criteria: Subjects who decline the invitation to take part. Subjects who are known to be non-compliant with medical treatment, Subjects who are known to be sensitive to any of the device components eg Gentamicin. Subjects with impaired renal function/autoimmune diseases/neuromuscular disease such as Parkinsons or Myasthenia Gravis Subjects taking Aminoglycoside antibiotics Subject is pregnant or actively breastfeeding; Subject has active or potential infection Subject has any significant or unstable medical or psychiatric condition that, in the opinion of the Investigator, would interfere with his/her ability to participate in the study; Subject is currently enrolled in another clinical study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Genta-Foil resorb<br>Genta-Foil resorb® is a transparent collagen foil that forms a temporary barrier between the functional structures during the critical phase of wound healing. As a result, the ability of the tissue layers to slide against each other is retained. The absorbability of equine collagen means the foil can be left in place and does not require removal. The addition of the antibiotic Gentamicin is for self-protection since collagen implants are prone to bacterial contamination. | Device: Genta-Foil resorb<br>* Use of Genta-Foil resorb to prevent adhesions in patients undergoing hand surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Restoration of hand mobility | Restoration of hand mobility will be assessed using Tendon Total Active Motion (TAM). Restriction of TAM post-surgery is indicative of tissue adhesions, therefore this measure (when compared with the unaffected contralateral finger(s)) will demonstrate presence / absence of of tissue adhesions. | Up to 30 days post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of device related adverse events |  | Up to 30 days post-surgery | 
| Time to resumption of normal daily activities |  | Up to 30 days post-surgery | 
| Wound closure without complications (number of patients without complications) | Surgical wound will be assessed by the investigator for dehiscence. Wound dehiscence will be classified as any separation of the apposed edges of the surgical wound (epidermis, dermis or subcutaneous layers). | Up to 30 days post-surgery | 
| Change in patient pain scores from baseline to end of follow-up | Assessed using VAS | Up to 30 days post-surgery | 
| Clinician satisfaction with the Genta-Foil device | Assessment of satisfaction with device conformability and ease of use. Assessed using a Likert-type scale. | Immediately post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hand Mobility, Wound Healing