Platelet-rich plasma gel combined with negative pressure wound therapy for managing subcutaneous dead space in chronic soft-tissue wounds: A prospective exploratory quasi-randomized pilot study.

AIM: To evaluate platelet-rich plasma (PRP) gel combined with negative pressure wound therapy (NPWT) for managing subcutaneous dead space in chronic soft-tissue wounds in an exploratory pilot study.

MATERIALS AND

METHODS

This prospective, single-centre, exploratory, quasi-randomized pilot study enrolled 50 adults with chronic soft-tissue wounds and dead space greater than 3 cm, identified by ultrasound (with MRI as an adjunct in anatomically complex cases). Patients were assigned by alternating allocation (a form of quasi-randomization, without concealment) to PRP gel plus NPWT or conventional anatomical closure plus NPWT, with 25 patients per group; sample size was not derived from a prospective power calculation. Aside from the presence or absence of PRP gel, both groups received an identical departmental protocol for debridement, wound closure technique, drainage, antibiotic prophylaxis, and NPWT settings, so that observed differences can be more specifically attributed to PRP gel rather than to concurrent-care variation. The primary outcome was residual dead space at 1 month on ultrasonography, using a prespecified sonographic definition. Secondary outcomes included hospital duration, pain, Wound Quality of Life score, final wound-closure time, and complications. An exploratory tissue-adequacy immunohistochemistry subset assessed CD31 and LYVE-1 vessel counts as hypothesis-generating biomarkers, not as evidence of causal mechanism.

RESULTS

Residual dead space at 1 month was observed in 0 of 25 PRP + NPWT patients and 4 of 24 assessed controls (0.0% vs. 16.7%; Fisher exact p = 0.0502; risk difference -16.7 percentage points, 95% CI -35.85 to -0.02). Sensitivity analyses ranged from p = 0.110 to p = 0.0502 according to the missing control ultrasound assumption. Hospital duration was shorter with PRP + NPWT (11.2±2.6 vs. 16.4±4.6 days, p < 0.001; mean difference -5.2 days, 95% CI -7.3 to -3.1), but final wound-closure time was not significantly shortened (mean difference 4.8 days, 95% CI -2.6 to 12.2, p = 0.20). Exploratory CD31 and LYVE-1 counts were higher at 1 month in PRP + NPWT-treated wounds (CD31 + mean difference 12.7 vessels/high-power field, 95% CI 8.5 to 16.9; LYVE-1+ mean difference 4.2, 95% CI 2.1 to 6.3).

CONCLUSION

PRP gel plus NPWT showed a favourable early signal for dead-space management in this small, unblinded, quasi-randomized pilot cohort, but confirmatory randomized evidence is required.