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"

NCT03668665 | Withdrawn Phase 3

• 1 other identifier: 18-068
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound Heal

Keywords

Split Skin Removal; Hyaloronic acid; Split Wound Design

Outcome Measures

Primary Outcomes (2)

• Effect of Ready Medical Post Treatment on wound healing after split skin removal

  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

  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

Study Arms (2)

Conventionell Treatment

ACTIVE COMPARATOR

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 with Ready Medical Post Treatment

EXPERIMENTAL

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

Interventions

Ready Medical Post Treatment DRUG

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

Also known as: Hyaluronic acid combined with perfluorodecalin and Physalis angulata extract

Treatment with Ready Medical Post Treatment

Conventionell Treatment DEVICE

Treatment of half of the wound with conventional moist dressings (Mepilex and Fixomull); a dressing change only takes place on the 7th day postoperatively

Also known as: Wound treatment with moist dressings

Conventionell Treatment

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

Department of oral and maxillofacial surgery, University Hospital RWTH Aachen Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

MeSH Terms

Interventions

perfluorodecalin

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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".
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: September 12, 2018
• Study Start: October 1, 2018
• Primary Completion: April 1, 2020
• Study Completion: October 1, 2020
• Last Updated: March 14, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)