NCT02164760

Brief Summary

In this study the safety and feasibility of an acellular dermal template (Novomaix), combined with split thickness skin grafts, for use in patients with full thickness skin defects, is tested. Results will be compared intra-patient with those obtained after conventional treatment with split thickness skin grafts. We expect this treatment to be safe, and to provide better outcome regarding scar quality.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2013

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 11, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 17, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

2.5 years

First QC Date

June 11, 2014

Last Update Submit

February 13, 2020

Conditions

Full Thickness Skin Defects

Keywords

burnsdermal substitutescar qualityreconstructionwound healingwound closure

Outcome Measures

Primary Outcomes (1)

  • Graft take (experimental vs control area)

    Subjective assessment of two experienced observers

    5-7 days postoperative

Secondary Outcomes (6)

  • Epithelialization

    5-7 and 18 ± 2 days days postoperative

  • Complication rate

    Up to 12 months postoperative

  • Scar quality

    3 months

  • Scar quality

    6 months

  • Scar quality

    9 months

  • +1 more secondary outcomes

Study Arms (2)

Dermal substitute with STSG

EXPERIMENTAL

Novomaix dermal substitute in combination with STSG

Device: Novomaix dermal substitute in combination with STSG

STSG alone

NO INTERVENTION

STSG alone

Interventions

Novomaix dermal substitute in combination with STSGDEVICE

Novomaix dermal substitute in combination with STSG

Also known as: Novomaix
Dermal substitute with STSG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years
  • with acute burns/trauma wounds that require skin grafting (group 1) OR
  • with scar problems requiring surgical treatment (group 2)
  • Full thickness skin defects of 50 cm2 or more, but \<50% TBSA
  • Skin defects must be configured in such a way that two areas of 25 cm2 can be grafted
  • Informed consent by the patient

You may not qualify if:

  • Patients with infected wounds
  • Pregnant or breast feeding females
  • Patients with known concomitant medical conditions that may interfere with normal wound healing (e.g. immune deficiency, HIV, diabetes, collagenoses, cancer)
  • Known allergy against porcine collagen or elastin
  • Patients who are expected (according to the responsible medical doctor) to be noncompliant to the study protocol. (This includes patients with severe cognitive dysfunction/impairment and severe psychiatric disorders)
  • Previous enrolment of the patient into the current study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Zentrum für Schwerbrandverletzte mit Plastischer Chirurgie

Berlin, 12683, Germany

Location

Red Cross Hospital

Beverwijk, North Holland, 1942 LE, Netherlands

Location

Related Publications (1)

  • Boekema BK, Vlig M, Olde Damink L, Middelkoop E, Eummelen L, Buhren AV, Ulrich MM. Effect of pore size and cross-linking of a novel collagen-elastin dermal substitute on wound healing. J Mater Sci Mater Med. 2014 Feb;25(2):423-33. doi: 10.1007/s10856-013-5075-2. Epub 2013 Nov 1.

    PMID: 24178984BACKGROUND

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Esther Middelkoop, Prof. dr.

    Red Cross Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2014

First Posted

June 17, 2014

Study Start

June 1, 2013

Primary Completion

December 1, 2015

Study Completion

June 1, 2016

Last Updated

February 17, 2020

Record last verified: 2020-02

Locations

DE(1)NL(1)