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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)

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ClinicalTrials.gov Identifier: NCT03668665
Recruitment Status : Withdrawn (no approval by CA)
First Posted : September 12, 2018
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Wound Heal Drug: Ready Medical Post Treatment Device: Conventionell Treatment Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The wound is divided into two halves (top and bottom). During the in-patient stay, half of the split skin removal sites are treated with Ready Medical Post Treatment on the 1st, 4th and 7th postoperative days in addition to conventional treatment with moist dressings (Mepilex and Fixomull). The other half of the wound should only be treated with conventional dressings as a control. Half of those treated with Ready Medical Post Treatment receive a new dressing after each application.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: The images taken from the wound as a progress control during the study should be evaluated anonymously by both the surgeon and the patient using the "Manchester Scar Scale" and the "Patient and Observer Scar Assessment Scale".
Primary Purpose: Treatment
Official Title: 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"
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Hyaluronic acid combined with perfluorodecalin and Physalis angulata extract




Primary Outcome Measures :
  1. 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)


  2. 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)




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03668665


Locations
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Germany
Department of oral and maxillofacial surgery, University Hospital RWTH Aachen Aachen
Aachen, NRW, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University

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Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT03668665    
Other Study ID Numbers: 18-068
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by RWTH Aachen University:
Split Skin Removal
Hyaloronic acid
Split Wound Design
Additional relevant MeSH terms:
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Wounds and Injuries
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents