A Single-stage Bilayered Skin Reconstruction With Glyaderm®

NCT06249971 | Completed

• 1 other identifier: B670201733327
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

The study will explore the potential of utilizing Glyaderm® in a single-stage engrafting process, aiming for a more cost-effective approach. While the absence of the reticular dermal layer is a challenge associated with autologous split-thickness skin grafting (STSG), often leading to hypertrophic scars and contractures, various dermal substitutes with inconsistent results exist. Bilayered skin reconstruction using glycerolized acellular dermis (Glyaderm®) has shown promise in improving scar quality through a two-step procedure. However, unlike the typical two-step process required for most dermal substitutes, our investigation focuses on the cost-effective application of Glyaderm® in a single-stage engrafting. This approach, if successful, could offer advantages such as reduced costs, shorter hospitalization times, and lower infection rates-attributes preferred by many surgeons, especially when autografts are available.

Conditions

Burns; Full Thickness Burn; Necrotizing Fascitis

Outcome Measures

Primary Outcomes (3)

• Graft take

  take of the skin graft 6 days post-surgery, expressed as a percentage

  7 days

• healing time

  the time needed until the wound is at least 95% closed AND does not need a significant wound dressing. Expressed in days.

  up to 1 month

• bacterial load

  The bacterial load is the amount of bacteria that is present in the wound, assessed with a wound swab. The bacterial load is expressed on a semi-quantative scale -,+,++,+++

  up to 1 month

Secondary Outcomes (6)

• scar hydration

  1 year

• scar water evaporation

  1 year

• scar elasticity

  1 year

• extracellular matrix formation

  1 year

• scar color, erythema

  1 year

Study Arms (2)

Split thickness skin graft alone

ACTIVE COMPARATOR

Intra-individual approach Patient has 2 comparable (near) full thickness skin defects or 1 (near) full thickness skin defect that can be divided into 2 comparable regions. Randomization: the defect randomized in this arm receives only a skin graft.

Procedure: Skin graft alone

Split thickness skin graft + Glyaderm

EXPERIMENTAL

Intra-individual approach Patient has 2 comparable (near) full thickness skin defects or 1 (near) full thickness skin defect that can be divided into 2 comparable regions. Randomization: the defect randomized in this arm receives a skin graft combined with Glyaderm

Procedure: Dermal subsitute Glyaderm + skin graft

Interventions

Dermal subsitute Glyaderm + skin graft PROCEDURE

A human donor-derived dermal substitute will be implanted together with a skin graft

Split thickness skin graft + Glyaderm

Skin graft alone PROCEDURE

Skin graft alone with no dermal substitute

Split thickness skin graft alone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All deep partial thickness and full-thickness burns as shown by laser Doppler imaging (LDI) and/or clinically evaluated by two plastic surgeons or a burn care coordinator
• Other full-thickness skin defects besides burns, e.g. necrotizing fasciitis, deglovements or phalloplasty donor sites after free flap harvest
• Possibility to follow the complete treatment schedule until final graft take and subsequently wound healing and participation in the follow-up schedule
• Informed consent has been obtained • Age between 18-80 years

You may not qualify if:

• All partial-thickness burns that can heal by conservative treatment confirmed by LDI • Not completing the treatment schedule or declining further follow-up • The patient has any condition(s) that seriously compromises the patient's ability to complete this study. • The patient has participated in another study utilizing an investigational drug within the previous 30 days • The patient has one or more medical condition(s) that, in the opinion of the investigator, would make the patient an inappropriate candidate for this study e.g. diabetes, renal or hepatic insufficiency, immune or neurologic disease

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Research Foundation Flanders: collaborator

Study Sites (1)

Ghent University Hospital

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Related Publications (1)

• De Decker I, Hoeksema H, Verbelen J, De Coninck P, Speeckaert M, De Schepper S, Blondeel P, Pirayesh A, Monstrey S, Claes KEY. A single-stage bilayered skin reconstruction using Glyaderm(R) as an acellular dermal regeneration template results in improved scar quality: an intra-individual randomized controlled trial. Burns Trauma. 2023 May 2;11:tkad015. doi: 10.1093/burnst/tkad015. eCollection 2023.

  PMID: 37143955 BACKGROUND

MeSH Terms

Conditions

Burns; Fasciitis, Necrotizing

Interventions

Skin Transplantation

Condition Hierarchy (Ancestors)

Wounds and Injuries; Fasciitis; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Dermatologic Surgical Procedures; Plastic Surgery Procedures; Surgical Procedures, Operative; Transplantation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Randomization only known to the surgeon and burn care coordinators, not the patient.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr Stan Monstrey

Model Details: A prospective, randomized, controlled, intra-individual, single-blinded study in a mono-center setting

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: February 8, 2024
• Study Start: February 1, 2017
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: February 8, 2024

Record last verified: 2024-01

Locations

BE (1)