ST250 as a Therapeutic Option for Head & Neck Reconstruction | NCT06543823

Studies
ST250 as a Therapeutic Option for Head & Neck Reconstruction

NCT06543823

Sponsor

Alaa Emara

Status

Recruiting

Last Update Posted

May 18, 2025Actual

Enrollment

60Estimated

Phase

Phase 1Phase 2

Conditions

Tonsillitis

Interventions

SupraTHEL 250
Comparator

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 30, 2025Actual

Primary Completion Date

Dec 2025Estimated

Completion Date

Feb 2026Estimated

First Submitted Date

Jul 31, 2024

First Submission Date that Met QC Criteria

Aug 5, 2024

First Posted Date

Aug 9, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 16, 2025

Last Update Posted Date

May 18, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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 opf 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study group	Sham Comparator	The wound bed is left bare after the tonsillectomy procedure	Other: Comparator
SupraTHEL 250 group	Experimental	The SupraTHEL 250 membrane is suture ionto the wound bed after the tonsillectomy procedure	Device: SupraTHEL 250

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SupraTHEL 250	Device	the membrane is placed onto the wound bed and fixed in place by resorbable interrupted sutures	SupraTHEL 250 group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain scores	Visual Analogue Scores (0-10; 0 lowest , 10 highest)	upto 5 days postoperatively

Secondary Outcomes

Measure	Description	Time Frame
Quality of Life , Tonsillectomy Outcome Inventory - 14	assessment of patients quality of life according to a set of questions	5 days Postoperative

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

recurrent episodes of tonsillar infection

Exclusion Criteria:

children
pregnant/ breastfeeding women
patients undergoing chemo / radiotherapy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alaa Emara	Contact	+49711719500-182		alaa.emara@polymedics.com

Overall Officials

Name	Affiliation	Role
Alaa Emara	Cairo University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MarienHospital	Recruiting	Stuttgart	Baden-Wurttemberg	71638	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014069	Tonsillitis

Ancestor Terms

ID	Term
D010612	Pharyngitis
D012141	Respiratory Tract Infections
D007239	Infections
D010608	Pharyngeal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided