Are there randomized controlled trials testing gelatide for wound healing or skin repair?
Executive summary
Randomized controlled trials (RCTs) of gelatin-based materials for wound care exist in a narrow set of clinical settings (for example palatal donor-site dressings and other small trials), but large-scale RCT evidence specifically testing "gelatide" as a distinct therapeutic for general skin repair is not documented in the provided sources (Frontiers, PubMed, PMC review) [1] [2] [3]. The literature returned here is dominated by preclinical and engineering studies of gelatin hydrogels and GelMA scaffolds showing accelerated wound closure in animal models and small exploratory human trials or protocols, not high‑power RCTs of a single marketed "gelatide" product [4] [5] [6].
1. What the term "gelatide" might mean — and why that matters
The search results focus on gelatin-derived hydrogels, gelatin methacryloyl (GelMA) and gelatin-based dressings rather than a clearly defined drug called "gelatide." Most papers describe biomaterials made from gelatin blended or crosslinked with other polymers and active agents (for example gelatin/gellan blends, gelatin–hyaluronic acid, GelMA), so if you mean a proprietary product named "gelatide," available sources do not mention a clinical RCT under that trade name; the corpus speaks to gelatin scaffolds and hydrogel platforms [7] [8] [6].
2. Preclinical animal data is strong and consistent
Multiple peer‑reviewed studies report that gelatin-based hydrogels accelerate wound healing in animal models: photocrosslinked gelatin hydrogels with sustained bFGF release improved wound healing and skin‑flap survival in rodents (Scientific Reports) and bioprinted gelatin‑alginate constructs sped re‑epithelialization in mice (Science Advances review) [4] [5]. Several 2024–2025 engineering and biomaterials papers document improved granulation, collagen deposition or re-epithelialization in mice or other in vivo models using gelatin composites, showing consistent preclinical efficacy [7] [9] [6].
3. Human clinical trials: small, exploratory, and uneven
Reviews and systematic overviews caution that gelatin for wound treatment remains at an early stage clinically and that large‑scale trials are lacking (Frontiers; PMC review) [1] [2]. The included clinical work tends to be small randomized trials in oral surgery settings (palatal wound dressings) or exploratory trial protocols (gelatin sheet plus platelet-rich plasma for chronic ulcers) rather than multicenter RCTs for broad skin wound repair [1] [2]. A comprehensive review of wound dressing materials catalogues many clinical trials of hydrogel dressings but does not single out a definitive, large RCT of a gelatin product for general skin healing in the sources provided [3].
4. What the RCT evidence does show (limited examples)
Some randomized clinical trials exist where gelatin products were compared in specific surgical or dental wound contexts (e.g., absorbable gelatin sponge vs comparator for palatal donor‑site healing), as cited in reviews (Frontiers; PMC) [1] [2]. These are context‑specific trials and not broad proof that all gelatin hydrogels improve every type of skin wound; the reviews explicitly state a need for larger trials to verify effectiveness across wounds [1] [2].
5. Why large-scale RCTs are still missing and what that implies
Authors repeatedly note that gelatin-based wound treatment is at an early translational stage and call for larger clinical trials; the field is rich in biomaterials innovation and animal proof-of-concept studies, but broad clinical validation is lacking [1] [2] [3]. That gap suggests regulatory and commercialization steps remain: formulations vary widely (crosslinkers, additives, growth factors), so aggregating them into a single evidence base is difficult and industry sponsors may not yet have supported large phase‑III style RCTs [10] [11].
6. Competing viewpoints and hidden agendas in the literature
Biomaterials papers emphasize engineering novelty and positive animal results (ACS, ACS Applied, Regenerative Biomaterials), while reviews and clinical summaries emphasize caution and the lack of large trials (Frontiers; PMC; Advances in Wound Dressing materials). Engineering groups have incentives to publish promising preclinical data; reviews and clinical literature stress that preclinical success does not equate to proven clinical benefit without adequately powered RCTs [7] [12] [1] [3].
7. Practical takeaways for clinicians and researchers
If you seek RCT evidence for a specific product called "gelatide," available sources do not mention such a trial; if your question targets gelatin‑based hydrogels broadly, the evidence is substantial in animals and limited but present in small, specific human trials—yet large, generalizable RCTs are not documented in the provided material [4] [5] [2] [1]. Researchers should pursue standardized formulations and multicenter trials; clinicians should treat current human data as preliminary and context‑dependent [2] [1].
Limitations: this review used only the provided search results; claims about trials outside these sources are not assessed here—available sources do not mention a multicenter phase‑III RCT of a marketed "gelatide" product.