An observational study in Tissue Adhesions, Surgery-Induced, sponsored by Advanced Medical Solutions Ltd.. Terminated at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-19.
Sponsored by Advanced Medical Solutions Ltd. · Observational
Single arm study to evaluate the safety and performance of Genta-Foil resorb® for the prevention of tissue adhesions
GENTA-FOIL resorb® 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 resorb® 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.
241 studies on the registry are indexed under Tissue Adhesions; 29 are open to participants now.
This study's enrollment of 15 is below the median of 146 across 49 observational studies indexed under Tissue Adhesions.
Browse Tissue Adhesions studies →Advanced Medical Solutions Ltd. is the lead sponsor of 14 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients who are undergoing hand surgery with the Genta-Foil resorb® device, and who meet all inclusion criteria and none of the exclusion criteria
Subject is scheduled for one if the following surgical procedures:
Exclusion Criteria:
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®
Use of Genta-Foil resorb® to prevent adhesions in patients undergoing hand surgery
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.
Time frame: At 90 days post-surgery
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.
Time frame: Up to 30 days post-surgery
Incidence of device related adverse events
Evaluation of safety of GENTA-FOIL resorb® 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Immediately post-surgery
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Advanced Medical Solutions Ltd.