Silver Foam Dressing Superior to Porcine Xenograft in Pediatric Scalds

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-11

Study Completion Date

2018-05-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Prospective randomized trial where two dressings has been compared for partial thickness scald burns in children 6 months to 6 years.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

PORCINE XENOGRAFT OR MICROBIAL CELLULOSE IN THE TREATMENT OF PARTIAL THICKNESS BURNS

NCT04412759

Burns Burn Scar Burn Second Degree

COMPLETED NA

Human Amniotic Versus Synthetic Membrane as a Transient Skin Cover for Pediatric Burns

NCT02904941

Burns

UNKNOWN NA

Mepilex Ag Versus Silver Sulfadiazine in Children and Adults With Burn Injuries.

NCT01439074

Burn Injuries

COMPLETED NA

Silver in Partial Thickness Pediatric Burns

NCT06971562

Pediatric Burns

ACTIVE_NOT_RECRUITING NA

Pediatric Burn Treatment Using Tilapia Skin as a Xenograft for Superficial-Partial Thickness Wounds

NCT04391582

Burns

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Aim: The aim of this study was to compare two different treatment regimes for children with partial-thickness scald burns. Burns were treated with either a porcine xenograft (EZderm®, Mölnlycke Health Care, Gothenburg, Sweden) or a silver foam dressing (Mepilex® Ag, Mölnlycke Health Care, Gothenburg, Sweden).

Methods: A prospective randomized clinical trial including 58 children admitted between May 2015 and May 2018 for partial-thickness scalds to The Burn Centre in Linkoping, Sweden. Primary outcome was time to wound closure. Secondary outcomes were pain, need of surgery, wound infection, length of hospital stay, required dressings changes, and labour time.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Burns Scald

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomised trial were children, after Guardians written consent,are randomized to one of two dressings.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Porcine xenograft

Conformité Européenne/European Conformity (CE)-marked dressing product used in clinical practise (Standard of care).

Group Type EXPERIMENTAL

Porcine xenograft (wound dressings)

Intervention Type OTHER

commercial porcine xenograft, derived from acellular dermis from porcine.

Silver foam

Conformité Européenne/European Conformity (CE)- marked dressing product used in clinical practise

Group Type ACTIVE_COMPARATOR

Silver foam (wound dressings)

Intervention Type OTHER

commercial silver containing foam dressing

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Porcine xenograft (wound dressings)

commercial porcine xenograft, derived from acellular dermis from porcine.

Intervention Type OTHER

Silver foam (wound dressings)

commercial silver containing foam dressing

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

EZderm from Mölnlycke Healthcare AB, Gothenburg, Sweden Mepilex Ag from Mölnlycke Healthcare AB, Gothenburg, Sweden

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Partial-thickness scald burns admitted within 72 hours of injury and with burns suitable for porcine xenograft according to the burn surgeon on duty were eligible and enrolled after (guardians) consenting to participate.