SUPRATHEL 250 as a Treatment for Oropharyngeal Wounds

Alaa Emara80 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Tonsillitis Tonsillectomy Tonsillitis Recurrent

Interventions

Suprathel 250DEVICE

The membrane is placed onto the wound bed and fixed in place by resorbable interrupted sutures.

ComparatorOTHER

no membrane is placed onto the wound bed , left bare to heal

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

* 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.

Locations (1)

Vinzenz von Paul Kliniken gGmbH Marienhospital Stuttgart

Stuttgart, Baden-Wurttemberg, Germany

RECRUITING

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

Central Contacts

Alaa Emara

CONTACT

+49711719500-182 alaa.emara@polymedics.com

Data from ClinicalTrials.gov

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