SUPRATHEL 250 as a Treatment for Oropharyngeal Wounds

Alaa Emara

Status: Enrolling

Conditions: Tonsillectomy; Tonsillitis; Tonsillitis Recurrent

Treatments: Device: Suprathel 250; Other: Comparator

Study type: Interventional

Funder types: Other

Identifiers

NCT06543823

ST250 mucosal application

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Study group

Sham Comparator group

Description:

The wound bed is left bare after the tonsillectomy procedure

Treatment:

Other: Comparator

Suprathel 250 group

Experimental group

Description:

The SupraTHEL 250 membrane is sutured onto the wound bed after the tonsillectomy procedure

Treatment:

Device: Suprathel 250