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Prospective randomized controlled trial of three different types of webspace reconstruction for congenital syndactyly
Yuxiao Wang1, Wen Tian2, Liying Sun2
1Department of Hand Surgery, Beijing Jishuitan Hospital, Capital Medical University, Beijing, China; Beijing Research Institute of Traumatology and Orthopaedics, Beijing, China; Peking University Fourth School of Clinical Medicine, Beijing, China.
Background:
Release of syndactyly includes the use of full-thickness skin grafts or graftless techniques with specially designed flaps. Recently, artificial dermal substitutes have been successfully used for web reconstruction without skin grafting. The aim of this study was to compare the results of the three techniques.
Methods:
This prospective, assessor-blinded, three-arm randomized controlled trial included 45 patients contributing 60 web spaces. The web space was the unit of randomization. Eligible web spaces were allocated in a 1:1:1 ratio to dorsal hexagonal flap, Pelnac® artificial dermis, or full-thickness skin graft reconstruction using computer-generated permuted-block randomization. The prespecified primary outcome was the web-creep grade at one year. Secondary outcomes included the Vancouver scar scale (VSS), scar grade, parent- and assessor-rated visual analog scales (VAS), and time to complete wound healing. Linear mixed-effects models accounted for patient-level clustering. Holm adjustment was applied separately to comparisons of the primary and secondary outcomes.
Results:
All 60 web spaces were analyzed. Web-creep grades did not differ significantly among the groups. Compared with skin grafting, VSS scores were lower with the flap (MD -1.56, 95% CI -2.34 to -0.79; adjusted p=0.003) and Pelnac® (MD -1.66, 95% CI -2.44 to -0.88; adjusted p=0.001). Healing took longer with Pelnac® than with the flap (MD 2.71 weeks, 95% CI 2.24-3.19; adjusted p<0.001) or skin graft (MD 1.74 weeks, 95% CI 1.25-2.23; adjusted p<0.001), and longer with skin grafting than with the flap (MD 0.98 weeks, 95% CI 0.49-1.46; adjusted p=0.003). No significant differences were found in the other esthetic outcomes.
Conclusion:
At one year, Pelnac® and dorsal hexagonal flap reconstruction resulted in lower VSS scores than skin grafting, whereas Pelnac® required longer healing duration. No technique demonstrated overall esthetic superiority and longer-term follow-up is required.