An observational study in Wounds and Injuries, Skin Graft Scar and Skin Graft Complications, sponsored by Federico II University. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-07.
Sponsored by Federico II University · Observational
Partial thickness skin grafts are widely used to cover large losses of substance secondary to trauma, burns, ulcers, neoplasms.
The donor site (SD), in principle, heals by spontaneous re-epithelialization from the epithelial residues of the skin appendages.
In the post-surgical management of the collection area, in order to optimize treatment, the following are necessary: control of nappy bleeding, management of transudate, avoid superinfection, promote rapid re-epithelialization and pain control.
The objective of the research proposed by us wants to compare two methods of dressing of the SD, one of which involves the use of impregnated gauze and cream with Rigenase and poliesanide (Fitostimoline Plus®) while the other the use of impregnated gauze and cream with hyaluronic acid, sodium salt and 1% silver sulfadiazine (Connettivina Bio Plus®) associated with non-adhesive polyurethane foam (i.e. without adhesive edge, i.e. Mepilex).
The prospective, multicentre study will be conducted at the UOC of Plastic and Reconstructive Surgery of our AOU directed by Prof F. D'Andrea and the UOC of Plastic and Reconstructive Surgery of ASUGI of Trieste directed by Prof Z. Arnez.
To date, there is still no standardized protocol on the wound care of the graft harvesting area. If the literature is evaluated, in fact, large variations in the management of SD are observed with a discrepancy between the practice and the evidence reported in the literature.
The purpose of our research is precisely to review the literature on the effectiveness of dressings at the sampling site level in terms of reducing pain and promoting rapid healing.
The management of the removal site of a partial thickness graft is still a subject of heated debate where, despite the published works, it is still often treated with empirical methods, sometimes which also differ within the same working group. The treatment of AD usually, despite what has been exposed in numerous scientific papers, only involves the use of greasy gauze impregnated with substances that promote re-epithelialization or simple paraffin gauze.
The aim of our research is to compare the effectiveness of bioactive dressings containing Rigenase in association with polyhexanide (PHMB) - Fitostimoline Plus®- with bioactive dressings with hyaluronic acid and Silver sulfadiazine - Connettivina Bio Plus®- in improving the outcome of patients, evaluating:
RESEARCH OBJECTIVES AND HYPOTHESIS The objective of the study proposed by us is to compare two methods of treating DS; the first involves the use of impregnated gauze and cream containing Rigenase® + polyhexanide; the second is the use of impregnated gauze and sodium salt hyaluronic acid cream. The secondary dressing is a non-adhesive polyurethane foam in both groups.
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's planned enrollment of 60 is below the median of 135 across 1,597 observational studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →Federico II University is the lead sponsor of 356 studies on the registry; 60 are open to participants now.
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All pantients aged between 18 and 80 years will be included in the trial if they accept to sign the informed consent.
Exclusion Criteria:
Formulation in gauzes and cream based on a particular Triticum Vulgare Extract (Rigenase®) and polyhexanide, an antiseptic which does not give any bacterial resistance.
Device: Fitostimoline plus · Device: Connettivina bio plus
Formulation in gauzes and cream based on hyaluronic acid and silver sulphadiazine.
Device: Fitostimoline plus · Device: Connettivina bio plus
Formulation in gauzes and cream
Formulation in gauzes and cream
Scarring
Comparing the two formulations in evaluating the scarring percentage of the lesions
Time frame: one month
This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Federico II University