Autologous cutis and subcutis micrografts combined with a collagen-elastin dermal scaffold for chronic wounds: a retrospective single-arm clinical study with prospectively collected data.

BACKGROUND: Chronic wounds remain a significant clinical challenge, characterised by sustained inflammation, impaired angiogenesis, and defective extracellular matrix remodelling. Autologous cutis and subcutis micrografts and collagen-elastin dermal scaffolds have each shown promise in wound healing, but their combination has not been previously investigated in a clinical study. This study aimed to evaluate the feasibility, safety, and preliminary effectiveness of autologous cutis and subcutis micrografts seeded onto a collagen-elastin dermal scaffold for the treatment of chronic wounds. METHODS: A single-arm, single-centre, retrospective analysis of prospectively collected data was conducted. Forty-four patients with chronic wounds were screened; 34 met the eligibility criteria and received the intervention. Following surgical debridement, autologous cutis and subcutis tissue was harvested by punch biopsies and mechanically disaggregated to produce a micrograft suspension, which was used to imbibe a collagen-elastin dermal scaffold before application to the wound bed. The primary outcome was percentage reduction in wound surface area at day 90, measured by digital planimetry. Secondary outcomes included complete wound closure rate, Bates-Jensen Wound Assessment Tool (BWAT) scores, wound bed tissue composition, patient-reported outcomes (pain Visual Analogue Scale, Wound-QoL, EQ-5D-5L), systemic inflammatory markers (C-reactive protein, erythrocyte sedimentation rate, neutrophil-to-lymphocyte ratio), nutritional markers (albumin, prealbumin), and adverse events. Assessments were performed at baseline and at days 7, 14, 30, 60, and 90. RESULTS: Thirty-four patients (mean age 62.8 ± 11.6 years; 58.8% male) were treated. Wound aetiologies included venous (35.3%), diabetic (26.5%), mixed arteriovenous (17.6%), pressure (11.8%), and post-surgical (8.8%) ulcers. The mean baseline wound surface area was 13.2 ± 9.1 cm2 with a median wound duration of 18 weeks. Thirty-two patients (94.1%) completed the 90-day follow-up. The mean wound surface area decreased from 13.2 ± 9.1 cm2 to 2.8 ± 3.6 cm2, corresponding to a mean reduction of 78.8% (95% CI, 71.4%-86.2%; p < 0.001). Complete wound closure was achieved in 21 of 34 patients (61.8%) by day 90, with a median time to closure of 71 days. Bates-Jensen Wound Assessment Tool scores improved from 37.8 ± 6.4 to 18.0 ± 6.6 (p < 0.001). Healthy granulation tissue increased from 31.8% to 90.6% of the wound bed (p < 0.001). Resting pain Visual Analogue Scale decreased from 5.8 ± 2.4 to 1.9 ± 1.6 (p < 0.001). Wound-QoL global score improved from 2.42 ± 0.74 to 0.88 ± 0.56 (p < 0.001), exceeding the minimal important difference. EQ-5D-5L index value improved from 0.56 ± 0.19 to 0.78 ± 0.15 (p < 0.001). Serum CRP decreased from 19.2 ± 13.4 to 5.8 ± 4.4 mg/L (p < 0.001), and albumin increased from 3.22 ± 0.50 to 3.74 ± 0.40 g/dL (p < 0.001). Fourteen adverse events occurred in 11 patients (32.4%); all were mild. No serious adverse events, hospitalisations, or amputations were recorded. CONCLUSION: The combination of autologous cutis and subcutis micrografts with a collagen-elastin dermal scaffold is a feasible and safe regenerative approach for chronic wounds, associated with substantial wound area reduction, high rates of complete closure, significant improvements in wound status, systemic inflammatory and nutritional markers, and patient-reported quality of life. Because the study lacked a concurrent control group, these results should be interpreted as evidence of feasibility and safety rather than of efficacy, and require confirmation in an adequately powered randomised controlled trial.