SUPRATHEL 250 as a Treatment for Oropharyngeal Wounds

ConditionsTonsillitis Tonsillectomy Tonsillitis Recurrent

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorAlaa Emara

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

Suprathel 250
Device
The membrane is placed onto the wound bed and fixed in place by resorbable interrupted sutures.
Comparator
Other intervention
no membrane is placed onto the wound bed , left bare to heal

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: Study groupSham comparator 1 intervention

Group B: Suprathel 250 groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Pain Intensity (VAS)

Visual Analogue Scores (0-10; 0 lowest , 10 highest)

Time frame

postoperative day 0, 1, 2, 3, 4, 5, 7 and 10

Secondary outcomes

Secondary Study Endpoints in Tonsillectomy Patients

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

Time frame

Screening -- until 10 days Postoperative

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alaa Emara

Lead sponsor

Cairo University

Sponsor institution

Source ClinicalTrials.gov

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