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NCT05447793: FP
Effectiveness and Tolerability of Fitostimoline Plus vs Connettivina Bio Plus in Skin Graft
trial testing Fitostimoline plus in Wounds and Injuries in 60 participants. Status unknown.
18 December 2021
Quick facts
| Lead sponsor | Federico II University |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 60 |
| Start date | 18 January 2021 |
| Primary completion | 18 December 2021 |
| Estimated completion | 18 September 2022 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Fitostimoline plus
- Connettivina bio plus
Conditions studied
- Wounds and Injuries — all drugs for Wounds and Injuries →
- Skin Graft Scar — all drugs for Skin Graft Scar →
- Skin Graft Complications — all drugs for Skin Graft Complications →
Sponsor
Federico II University
Who can join
Adults 18 to 80, any sex, with Wounds and Injuries or Skin Graft Scar. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05447793
- Europe PMC full search
- ASCO Meeting Library
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05447793 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Federico II University
- Last refreshed: 7 July 2022
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