Tonsillectomy, Tonsillitis, Tonsillitis Recurrent
Conditions
Keywords
PLA membrane, Biodegradable membrane, Synthetic, Tonsillectomy, Suprathel
Brief summary
To assess the use of Suprathel 250 for mucosal reconstruction in oropharyngeal defects. The membrane will be applied after tonsillectomy procedures and compared to bare wounds' healing
Detailed description
After tonsillectomy procedures, the wound is usually left bare to heal. This causes severe pain postoperatively and postoperative hemorrhage. Suprathel 250 is a synthetic biodegradable PLA membrane which is proven as a skin membrane in burn wounds with excellent result. We therefore hypothesize that the use of Suprathel 250 after tonsillectomy procedures will allow for faster , less painful healing of the wound bed which allows for a better quality of life for the patients.
Interventions
DEVICESuprathel 250
The membrane is placed onto the wound bed and fixed in place by resorbable interrupted sutures.
OTHERComparator
no membrane is placed onto the wound bed , left bare to heal
Sponsors
Alaa Emara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Intervention model description
An interventional group with the application of the Suprathel 250 membrane and the control group with no membrane applied on the wound bed.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Indication for tonsillectomy according to the applicable clinical guideline. * Male or female patients aged 18 years or older. * Ability to understand the study information and provide written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity (VAS) | postoperative day 0, 1, 2, 3, 4, 5, 7 and 10 | Visual Analogue Scores (0-10; 0 lowest , 10 highest) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Study Endpoints in Tonsillectomy Patients | Screening -- until 10 days Postoperative | CRP Description: CRP, venous blood. Time Frame: Day 4 Unit: mg/L IL-6 Description: IL-6, venous blood. Time Frame: Day 4 Unit: pg/mL Hemoglobin Description: Hb, venous blood. Time Frame: Day 4 Unit: g/dL Speaking, Chewing, Swallowing Function Description: Problems reported, yes/no. Time Frame: Days 2-5, 7, 10 Unit: Participants Wound Healing Rating Description: Investigator Wound Healing Rating Scale, range 1-5; 1 best, 5 worst. Time Frame: Days 1-5 Unit: Score Quality of Life Score Description: Tonsillectomy Outcome Inventory 14, 33 items, 0-5 each; range 0-165, higher worse. Time Frame: Day 5 Unit: Score Total Daily Analgesic Dose Description: Daily amount, medication diary. Time Frame: Days 1-5 Unit: mg Participants With Complications or Adverse Events Description: Hemorrhage, allergy, infection, inflammation, reoperation, other AEs. Time Frame: Screening to day 10 Unit: Participants |
Countries
Germany
Contacts
CONTACTAlaa Emara
PRINCIPAL_INVESTIGATORAlaa Emara
Cairo University
Outcome results
None listed