Influencing Wound Healing Through the Application of Hyaluronic Acid With Perfluorodecalin and Physalis Angulata Extract After Split Skin Removal From the Thigh - A Study in "Split Wound Design" (Split Wound)

March 12, 2019 updated by: RWTH Aachen University
The study will use a split wound design to investigate whether secondary wound healing can be accelerated and improved by the application of hyaluronic acid combined with perfluorodecalin and Physalis angulata extract.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

In oral and maxillofacial surgery, split skin is regularly removed to cover secondary defects. These defects occur, for example, in tumor patients after the removal of microsurgical radialis or fibular grafts for defect coverage or reconstruction, since the skin cannot be primarily closed there.

Split skin is defined as a free skin graft made of epidermis and the upper parts of the dermis. The average thickness of the grafts is 0.2-0.8 mm. The thickness of the split skin determines the pigmentation structure and the quality of the graft. The thinner the split skin, the better the healing tendency and the less scar remains at the donor site. However, a disadvantage of thin split skin grafts is the stronger secondary shrinkage in the recipient region. Moderately thick grafts are hardly subject to scar shrinkage, but occasionally leave hypertrophic scars or keloids at the donor site. Split skin grafts with a thickness of 0.6-0.8 mm provide the best esthetic results, but have a poorer healing rate.

The split skin can be removed with a dermatome. The ventrolateral proximal thighs and the inside and outside of the upper arms are particularly suitable as donor regions.

In oral and maxillofacial surgery, a 0.4 mm thick split skin is usually removed from the ventrolateral thigh to cover the defect in the forearm or lower leg.

The requirement at the split skin removal site is rapid healing with complete re-epithelialization. To achieve this, wound management is currently left to the clinic itself, as there is no evidence-based standard care. The technical literature only recommends moist wound management and rare dressing changes.

A new product that promises faster healing and reduced scarring of these wounds is Ready Medical Post Treatment. This is an established preparation consisting of hyaluronic acid, perfluorodecalin and Physalis angulata extract. Studies have shown that both hyaluronic acid and perfluorodecalin can significantly improve the epithelialisation rate of wounds. The study will use a split wound design to investigate whether secondary wound healing can be accelerated and improved by the application of hyaluronic acid combined with perfluorodecalin and Physalis angulata extract.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Aachen, NRW, Germany, 52074
        • Department of oral and maxillofacial surgery, University Hospital RWTH Aachen Aachen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 18-90 years
  • Split skin removal at the thigh must be planned for the patients
  • Adult patients who are mentally and physically able to understand the importance and scope of the study and to follow up the study staff
  • Written informed consent before participating in the study

Exclusion Criteria:

  • Patients suffering from a systemic disease (e.g. diabetes mellitus, anticoagulant therapy,...)
  • Patients taking immunosuppressive drugs that may affect wound healing
  • Patients suffering from skin diseases
  • Pregnant and/or lactating women. Women of childbearing age should protect themselves from potential pregnancy by adequate contraception while participating in studies.
  • Participation in a study may, at the investigator's discretion, present an unacceptable risk due to pre- or concomitant disease or the patient's general underlying condition.
  • Underage, or older than 90 years
  • Life span is less than six months
  • There is a current or past medically relevant disease or treatment that could influence the evaluation of the study
  • The patient has received a study medication within the last 30 days as part of another study
  • Simultaneous participation in another clinical intervention study
  • Expected lack of compliance
  • Alcohol or drug abuse
  • The patient is accommodated in an institution by official or court order
  • Patients in a dependent relationship or employment relationship with the sponsor, investigator, or alternate investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventionell Treatment

After split skin removal, the wound is divided into 2 parts (=2 arms):

1st half: conventional treatment with moist dressings (mepilex and fixomull)
Device: Conventionell Treatment
Treatment of half of the wound with conventional moist dressings (Mepilex and Fixomull); a dressing change only takes place on the 7th day postoperatively
Other Names:
  • Wound treatment with moist dressings
Experimental: Treatment with Ready Medical Post Treatment

After split skin removal, the wound is divided into 2 parts (=2 arms):

2nd half: conventional treatment with moist dressings (mepilex and fixomull) and additional treatment with ready medical post treatment
Drug: Ready Medical Post Treatment
Treatment of half of the wound with the product "ready medical post treatment" in addition to conventional treatment with moist dressings (Mepilex and Fixomull); on the 1st, 4th and 7th day after surgery, the product is applied to the wound and the dressing is changed
Other Names:
  • Hyaluronic acid combined with perfluorodecalin and Physalis angulata extract

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of Ready Medical Post Treatment on wound healing after split skin removal
Time Frame: 6.5 month

Evaluation of the process control of wound healing (three-dimensional scans of the thigh) by surgeons and patients using questionnaire (wound assessment by "Patient and Observer Scar Assessment Scale")

Patient and Observer Scar Assessment Scale: Vancouver Scar Scale, surface area; patient assessments of pain, itching, color, stiffness, thickness, relief (Score from 5 (best) to 50 (worse)
6.5 month
Effect of Ready Medical Post Treatment on wound healing after split skin removal
Time Frame: 6.5 month

Evaluation of the process control of wound healing (three-dimensional scans of the thigh) by surgeons and patients using questionnaire (wound assessment by "Manchester Scar Scale")

Manchester Scar Scale: VAS (Visual Analog Scale) plus scar color, skin texture, relationship to surrounding skin, texture, margins, size, multiplicity (Score from 5 (best) to 18 (worse)
6.5 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RWTH Aachen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2018

Primary Completion (Anticipated)

April 1, 2020

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

September 5, 2018

First Submitted That Met QC Criteria

September 10, 2018

First Posted (Actual)

September 12, 2018

Study Record Updates

Last Update Posted (Actual)

March 14, 2019

Last Update Submitted That Met QC Criteria

March 12, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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