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slow recruitment.
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| Name | Class |
|---|---|
| Newcastle-upon-Tyne Hospitals NHS Trust | OTHER |
| KAT General Hospital | OTHER |
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Single arm study to evaluate the safety and performance of Genta-Foil resorbĀ® for the prevention of tissue adhesions
GENTA-FOIL resorbĀ® is an implantable, absorbable collagen barrier foil, which 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 objective of hand surgery is to promote wound repair, and regeneration of all motor and sensory functions of the hand and to restore the subject's hand mobility, and improve their quality of life. However, hand trauma and operations often lead to the formation of adhesions between the various tissue layers of the hand (e.g. muscles, tendons and nerves). Even with minimally invasive procedures and optimal aftercare, development of adhesions in the suture and wound areas is often unavoidable. Adhesion formation between repaired tendons and the surrounding tissue has been thought to be one of the most important factors that disturbs functional restoration. It is estimated that the adhesion, which can cause significant disability, occurs in about 30% of cases.
The purpose of this study is to investigate the use of GENTA-FOIL resorbĀ® for the prevention of tissue adhesions measured by restoration in digital function in subjects undergoing hand surgery. The functional outcome of tendon injury after a repair depends on multiple factors such as age, injury level and type, type of repair, and post repair therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genta-Foil resorbĀ® | Genta-Foil resorbĀ® 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genta-Foil resorbĀ® | Device | Use of Genta-Foil resorbĀ® to prevent adhesions in patients undergoing hand surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Restoration of hand mobility | Restoration of hand mobility will be assessed using functional assessment scoring Total Active Motion (TAM) at 90 days post-surgery. This will be measured by the modified Strickland scoring criteria. The success criteria is defined as TAM score of 75% or above at 90 days post-surgery. Restriction of TAM post-surgery is indicative of tissue adhesions, therefore this measure will demonstrate presence / absence of of tissue adhesions. | At 90 days post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of device related infections at surgical site up to 30 days post-surgery. | As per local Standard of Care wound assessment, absence or presence of wound signs infection will be recorded. | Up to 30 days post-surgery |
| Incidence of device related adverse events |
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Inclusion Criteria:
Subject is male or female, ā„18 years of age;
Subject is willing and able to give written informed consent;
Subject is scheduled for one if the following surgical procedures:
Subject is willing and able to comply with the study procedures during surgery and the post-surgical follow up period.
Exclusion Criteria:
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Adult patients who are undergoing hand surgery with the Genta-Foil resorbĀ® device, and who meet all inclusion criteria and none of the exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Lipscombe | Whiston Hospital Mersey and West Lancashire Teaching Hospitals NHS Trust, Warrington Rd, Rainhill, Prescot | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KAT Attica General Hospital | Athens | Athens | 14561 | Greece | ||
| Whiston Hospital - Mersey and West Lancashire Teaching Hospitals Trust |
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| ID | Term |
|---|---|
| D000267 | Tissue Adhesions |
| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Evaluation of safety of GENTA-FOIL resorbĀ® by recording of any device or procedure-related adverse events throughout the surgery during the follow-up period (day of surgery, at 7 days, 14 days, 30 days and 90 days post-surgery) |
| Up to 90 days post-surgery |
| Subjective assessment of symptoms and abilities to perform activities by 90 days post-surgery | Study subjects requested to self assess symptoms and abilities to perform activities by 90 days post-surgery. Subjects will be asked to complete the standardised QuickDASH upper extremity outcome measure questionnaire. QuickDASH Outcome Measure tool measures the individual's ability to complete tasks at home and severity of symptoms. The tool uses 11 questions and a 5-point Likert Scale from which the patient can select an appropriate number corresponding to their severity / function level. | At 90 days post-surgery |
| Wound healing without complications up to 30 days post-surgery. | Standard of Care wound assessments will be performed at follow-up visits at day 7, day 14 and day 30 as appropriate, by a designated member of the Hand Dressing Clinic as per local Outpatient Wound Assessment Tool. As part of wound assessment, date of when wound is healed will be recorded during appropriate follow-up visit. | Up to 30 days |
| Change in patient pain scores (assessed using VAS) up to 90 days post-surgery. | Severity of localised pain in the affected hand or finger(s) will be measured using a Visual Analogue Scale (VAS). The VAS will be a 10cm horizontal line, with descriptors at each end [no pain (0cm), and worst imaginable pain (10cm)]. Subjects will be asked to place a mark on the scale that corresponds to their pain. The distance from the lower end of the scale will be measured and recorded. | Up to 90 days post-surgery |
| Clinicians' satisfaction with the device at time of surgery | Assessment of satisfaction with device conformability and ease of use. Assessed using a Likert-type scale. | Immediately post-surgery |
| Rainhill |
| Merseyside |
| L35 5DR |
| United Kingdom |
| Royal Victoria Infirmary Newcastle Upon Tyne NHS Foundation Trust | Newcastle upon Tyne | Tyne and Wear | NE1 4LP | United Kingdom |