NCT Number: NCT07366281
The goal of this clinical trial is to evaluate the feasibility, safety, and performance of the new adhesive when used in the immediate post-operative period after total laryngectomy.
The main question it aims to answer is:
- Is the adhesive feasible and safe to use during the early post-operative phase?
This is a single-arm feasibility study with historical controls, so there is no concurrent comparison group. Researchers will compare outcomes to historical data from standard adhesive use to assess improvements in tolerance and skin condition.
Participants will:
* Use the adhesive as part of their standard post-laryngectomy care. * Complete patient-reported outcome questionnaires (e.g., comfort, skin assessment, satisfaction). * Allow investigators to record observations in diaries and patient charts. * Participate in routine clinical assessments during hospitalization and at end of study (approximately 30 days post-surgery).
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Amsterdam, 1066 CX, Netherlands
Ahmed Alkashaf
SUB_INVESTIGATOR
Klaske van Sluis
SUB_INVESTIGATOR
Michiel W.M. van den Brekel, Prof. Dr.
CONTACT
Michiel W.M. van den Brekel, Prof. Dr.
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The new Provox Life Comfort adhesive is a medical adhesive baseplate designed for tracheostoma care in laryngectomy patients.
Time frame: From enrollment to the end of treatment at 30 days.
Ability to use new adhesive continuously during the postoperative period, without discontinuation due to intolerance or complications related to the adhesive. Assessed through patient diary and investigator review.
Time frame: From enrollment to the end of treatment at 30 days.
Presence of skin reactions under or around the adhesive and pain/discomfort, assessed by investigator and patient. Skin condition evaluated using the Skin Integrity Severity Assessment Scale (0 = Normal, 1 = Mild, 2 = Moderate, 3 = Severe) and investigator assessment of erythema, vesicles, maceration, skin tears, crusting, and edema. Includes reported discomfort (VAS 0-10).
Time frame: From enrollment to the end of treatment at 30 days.
Ability of adhesive to remain attached during intended wear period, assessed on a 5-point scale of Adhesion Rating Scale, that ranges from "Adhesion of Adhesive is very bad " to "Adhesion of Adhesive is very good".
Time frame: From enrollment to the end of treatment at 30 days.
Hours adhesive remains in place before replacement.
Time frame: From enrollment to the end of treatment at 30 days.
Investigator and patients assessment of adhesive fit around stoma, assessed on a 5-point Stoma Fit scale ranging from "Adhesive does not fit at all" to "Adhesive fits very well".
Time frame: From enrollment to the end of treatment at 30 days.
Patient and investigator rating/assessment of how easy adhesive is to apply and remove, assessed on a 5-point scale ranging from "Very difficult" to "Very easy".
Time frame: From enrollment to the end of treatment at 30 days.
Whether skin under adhesive can be inspected without removal.
Time frame: From enrollment to the end of treatment at 30 days.
Feasibility of applying adhesive over sutures without complications.
Time frame: From enrollment to the end of treatment at 30 days.
Ability to speak while the Comfort Adhesive is in place will be assessed by both the patient and the investigator using a binary response (Yes/No). A "Yes" response indicates the participant is able to speak with a voice prosthesis while using the Comfort Adhesive. Higher frequency of "Yes" responses reflects a better outcome.
Time frame: From enrollment to the end of treatment at 30 days.
Hours of heat and moisture exchanger use per 24 hours.
Time frame: From enrollment to the end of treatment at 30 days.
Difficulty with sputum clearance while using the adhesive will be assessed by patient and investigator using a 4-point Mucus Trapping Scale ranging from "Mucus gets often trapped under the adhesive" to "Mucus never gets trapped under the adhesive".
Time frame: From enrollment to the end of treatment at 30 days.
Need for supplemental oxygen will be assessed by investigator confirmation using a categorical response:
Time frame: From enrollment to the end of treatment at 30 days.
Patient-reported comfort level using adhesive, assessed on a 5-point Comfort Scale ranging from "Very Uncomfortable" to "Very Comfortable."
Atos Medical AB
Industry
Post-operative Use of the New Adhesive After Total Laryngectomy
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07369050
Laryngectomy
Houston, Texas, United States
View Trial DetailsNCT06856863
Laryngectomy, Total Pharyngo-laryngectomy
Marseille, France
View Trial DetailsNCT05349487
Head and Neck Neoplasms, Laryngeal Cancer
Miami, Florida, United States
View Trial DetailsNCT06674564
Head and Neck Neoplasms, Laryngeal Diseases
Cairo, Al Abbasya, Egypt
View Trial Details