Evaluation of Digit Tip and Split Skin Donor Site Transcriptome

• Sponsor: University Hospital Schleswig-Holstein (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05991765
• Collaborator: (none)
• Enrollment: 75
• Location: 1
• Anticipated Duration (Months): 31
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief Summary

Regrowth of amputated fingertips presents a unique regenerative healing process in mammals, with subcutaneous volume regrowth, restoration of the dactylogram, and suppression of scar formation. In addition, wound healing from split-thickness donor sites shows almost scar-free healing. Transcriptome analysis is necessary to better understand the specific healing mechanisms of these two wound entities. Since no data are available to date, this study aims to fill the gap.

Condition or Disease	Intervention/Treatment	Phase
Digit Tip Wound; Split Skin Donor Site	Other: Digit Tip Wound; Other: Split Skin Donor Site Wound

Detailed Description

Regrowth of amputated fingertips presents a unique regenerative healing process in mammals, with subcutaneous volume regrowth, restoration of the dactylogram, and suppression of scar formation. In addition, wound healing from split-thickness donor sites shows almost scar-free healing. Transcriptome analysis is necessary to better understand the specific healing mechanisms of these two wound entities. Since no data are available to date, this study aims to fill the gap.

Study Design

• Study Type: Observational
• Actual Enrollment: 75 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Evaluation of Digit Tip and Split Skin Donor Site Transcriptome
• Actual Study Start Date: Jun 1, 2021
• Actual Primary Completion Date: Apr 30, 2022
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Digit Tip Wound Experimental Wound Exudate from Digit Tip Wounds	Other: Digit Tip Wound; Digit Tip Wound Exudate Sample Collected while Dressing Change
Split Skin Donor Site Wound Active Comparator Wound Exudate from Split Skin Donor Site Wound	Other: Split Skin Donor Site Wound; Split Skin Donor Site Wound Exudate Sample while Dressing Change

Outcome Measures

Primary Outcome Measures

1. Differences in RNA-Expression pattern [5 Weeks]

   Differences in RNA-Expression pattern between Digit Tip Wound and Split Skin Donor Site Wound

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

Inclusion Criteria:

1. Digit Tip Wound: Wound Exudate from healthy patients: Consent-capable patients ≥18 years of age with clean Digit Tip Wound

2. Split Skin Donor Site Wound: Wound Exudate from healthy patients: Consent-capable patients ≥18 years of age with clean Split Skin Donor Site Wound

Exclusion Criteria:

• Inflammation

• Borderline

• Infectious Disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Schleswig-Holstein	Lübeck	Schleswig-Holstein	Germany	23538

Sponsors and Collaborators

• University Hospital Schleswig-Holstein

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tobias Kisch, Principal Investigator, University Hospital Schleswig-Holstein
• ClinicalTrials.gov Identifier: NCT05991765
• Other Study ID Numbers: DigitTip2023
• First Posted: Aug 15, 2023
• Last Update Posted: Aug 15, 2023
• Last Verified: Aug 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Tobias Kisch, Principal Investigator, University Hospital Schleswig-Holstein: Digit Tip; Split Skin Donor Site; Transcriptome

Study Results

No Results Posted as of Aug 15, 2023