ST250 as a Therapeutic Option for Head & Neck Reconstruction

ConditionTonsillitis

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorAlaa Emara

About this trial

To assess the use of SupraThel 250 for mucosal reconstruction in the Head \& Neck region. The membrane will be applied after tonsillectomy procedures and compared to bare wounds' healing

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

recurrent episodes of tonsillar infection

Disqualifiers

children

pregnant/ breastfeeding women

patients undergoing chemo / radiotherapy

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

60 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 scores

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

Time frame

upto 5 days postoperatively

Secondary outcomes

Quality of Life , Tonsillectomy Outcome Inventory - 14

assessment of patients quality of life according to a set of questions

Time frame

5 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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