Trial of Different Wound Dressings in Split-skin Grafted Third Degree Burns

NCT03674151 | Unknown DMC

• 1 other identifier: 15-145-2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

In plastic and reconstructive surgery, treatment strategies of second-degree burn wounds and split-skin grafted third-degree burn wounds aim at reducing infection and improving reepithelialization. Although previous studies indicate that burn patients benefit from newer wound dressings, only a few studies comparing different wound dressings can be found. Therefore, the aim of this study is to evaluate time to reepithelialization, pain, microbiology, handling and costs of different wound dressings in patients with split-skin grafted third-degree burn wounds.

Conditions

Split-skin Grafted Third-degree Burn Wound

Keywords

split-skin; burn wound; wound dressing; comparison; silver; honey; PVP-Iod; hydrogel

Outcome Measures

Primary Outcomes (1)

• Epithelialization

  Percent of epithelialized area

  through study completion, an average of 1 year

Secondary Outcomes (3)

• Pain (on a visual analogue scale 0-10)

  through study completion, an average of 1 year

• Microbiologic Smear

  through study completion, an average of 1 year

• Subjective Handling

  through study completion, an average of 1 year

Study Arms (4)

Device: Silver Nylon dressing

ACTIVE COMPARATOR

1/4 of a split-skin grafted third-degree burn wound in a Group (n=20): Consent-capable male and female patients ≥18 years of age who have a split-skin grafted third-degree burn on ≥3% and ≤30% of the surface of the body.

Device: Silver Nylon dressing

Device: Manuka-Honey

ACTIVE COMPARATOR

1/4 of a split-skin grafted third-degree burn wound in a Group (n=20): Consent-capable male and female patients ≥18 years of age who have a split-skin grafted third-degree burn on ≥3% and ≤30% of the surface of the body.

Device: Manuka-Honey

Device: Povidone-Iod (PVP-Iod)

ACTIVE COMPARATOR

1/4 of a split-skin grafted third-degree burn wound in a Group (n=20): Consent-capable male and female patients ≥18 years of age who have a split-skin grafted third-degree burn on ≥3% and ≤30% of the surface of the body.

Device: Povidone-Iod (PVP-Iod)

Device: Hydrogel

ACTIVE COMPARATOR

1/4 of a split-skin grafted third-degree burn wound in a Group (n=20): Consent-capable male and female patients ≥18 years of age who have a split-skin grafted third-degree burn on ≥3% and ≤30% of the surface of the body.

Device: Hydrogel

Interventions

Silver Nylon dressing DEVICE

Non-staining Silver Nylon dressing with a permanently plated metallic surface on split-skin grafted third-degree burn wound

Device: Silver Nylon dressing

Manuka-Honey DEVICE

Manuka-Honey dressing on split-skin grafted third-degree burn wound

Device: Manuka-Honey

Povidone-Iod (PVP-Iod) DEVICE

Povidone-Iod (PVP-Iod) dressing on split-skin grafted third-degree burn wound

Device: Povidone-Iod (PVP-Iod)

Hydrogel DEVICE

Hydrogel dressing on split-skin grafted third-degree burn wound

Device: Hydrogel

Eligibility Criteria

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

You may qualify if:

• Consent-capable male and female patients
• ≥18 years of age
• ≥3% and ≤30% total body surface area (TBSA) split-skin grafted third-degree burn
• appropriate form of wound (not: too small) and localization (not: face, inplane surface)
• ability to asses pain

You may not qualify if:

• Immunosuppressive Therapy
• Clinical wound infection
• Allergy against porcine material, bee poison or honey, etherial oil, propyleneglycol, silver, nylon
• Relationship to someone who is involved in the study design or assessment
• Participation in other clinical trials
• Citizen of countries outside Europe

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead
• University of Luebeck: collaborator

Study Sites (1)

University of Schleswig-Holstein

Lübeck, Schleswig-Holstein, 23538, Germany

RECRUITING

MeSH Terms

Conditions

Burns

Interventions

Bandages, Hydrocolloid

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Bandages; Equipment and Supplies

Study Officials

• Tobias Kisch, MD

  University Hospital Schleswig-Holstein

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tobias Kisch, MD

CONTACT

00494515003580; tobias.kisch@uni-luebeck.de

Reinhard Vonthein, PhD

CONTACT

00494515002788; vonthein@zks-hl.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 28, 2017
• First Posted: September 17, 2018
• Study Start: July 1, 2015
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 24, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)