Early orthoplastic soft-tissue coverage in open tibial fractures reduces infection, nonunion, and amputation

Table 1 Characteristics and outcomes of studies evaluating early vs delayed soft-tissue coverage in open tibial fractures

Ref.	Study design	Sample size (n)	Population/fracture type	Definition of early coverage	Comparison group	Fixation method	Flap type/method	Primary outcomes	Infection/complication rate	Amputation/Limb salvage rate
Khan et al[12], 2025	Retrospective cohort	51 patients (52 extremities)	Gustilo-Anderson type IIIB and IIIC open tibial fractures	≤ 72 hours post-fixation	> 72 hours post-fixation	Definitive fracture fixation (not specified)	Local vs free flaps (muscle or fasciocutaneous)	Deep surgical site infection, nonunion	Deep infection: 43% in free flaps vs 0% in local flaps; trend toward higher infection when > 72 hours (30% vs 18%); nonunion more frequent in free flaps (43%) than local (9%)	Not reported
Henry et al[13], 2023	Retrospective cohort (long-term follow-up)	81 patients	Gustilo-Anderson type IIIB open tibial fractures	Early orthoplastic “fix-and-flap” with adjuvant antibiotic hydroxyapatite	No comparison group	Internal fixation (limb reconstruction)	Combined orthoplastic flap coverage with local antibiotic bio-composite	Bone union, deep infection, limb salvage	Deep infection: 3.7%; union achieved in 96%	Limb salvage: 96.3%
Sacks et al[14], 2023	Multisite retrospective cohort	80 patients (44 India, 36 United States)	Gustilo-Anderson type IIIB and IIIC open tibial fractures requiring free flap coverage	Early total debridement cohort (mean 1.84 debridements)	Serial debridement cohort (mean 3.64 debridements)	Definitive fixation before flap	Free tissue transfer (flap type not specified)	Infection, nonunion, flap failure	Infection and nonunion significantly higher in serial-debridement group (P < 0.05); no difference in flap failure	Not reported
Zamorano et al[15], 2025	Retrospective cohort	41 patients	Gustilo-Anderson type IIIB open tibial fractures	Flap coverage ≤ 12 days post-injury	Flap coverage > 12 days	Standardized fixation under level I trauma protocol	Soft-tissue flap (type not specified)	Fracture-related infection	Infection: 0% when ≤ 12 days vs 56.6% when >12 days (P < 0.01); AUC = 0.83 for 12-day threshold	Not reported
Cochonat et al[16], 2025	Retrospective cohort	35 patients	Open tibial fractures requiring flap coverage (mean age 45 ± 17.3 years; 88.6% male)	Flap coverage ≤ 7 days	Flap coverage > 7 days	Internal fixation (not specified)	Soft-tissue flap (not specified)	Infection, nonunion, flap failure, amputation	Infection significantly higher when > 7 days (72.2% vs 17.6%, P < 0.05); nonunion 24.2%; flap failure 143%; amputation 8.6%	Amputation 8.6% (all infected cases)
Chua et al[17], 2014	Comparative retrospective study	89 patients (83 men, 6 women; mean age 38 years)	Gustilo-Anderson type IIIB and IIIC open tibial fractures	Flap coverage ≤ 72 hours post-fixation	Flap coverage > 72 hours	Fracture fixation within 24 hours (method not specified)	Soft-tissue flap (not specified)	Bone union, infection, flap failure, secondary procedures	Deep infection: 23% (early) vs 54% (late), P < 0.01; shorter hospital stay and fewer procedures in early group	No significant difference
Sreedharan et al[18], 2024	Retrospective cohort (prospective database review)	148 open leg injuries (100 limb salvage, 21 primary amputation)	Open tibial fractures (metaphyseal, diaphyseal, epiphyseal)	Not specified (timing analyzed but not stratified)	Limb salvage vs primary amputation	Internal and external fixation (definitive external fixation linked to higher nonunion)	Various soft-tissue reconstructions (not specified)	Bone union, mobility, pain, infection	Higher nonunion and infection with external fixation; timing not associated with increased complications	21% primary amputation; 96% of salvaged limbs ambulated
Mahmoud et al[19], 2024	Retrospective cohort	55 patients	Adult patients (> 18 years) with open midshaft tibial fractures requiring flap coverage	Flap coverage ≤ 7 days	Coverage > 7 days	Not specified	Flap coverage (type not specified)	Deep infection, nonunion, flap failure, revision surgery	Deep infection: 6% (early) vs 38% (delayed), P = 0.01; revision surgery: 17% vs 54%, P = 0.008	Not specified
Cao et al[20], 2022	15-year retrospective cohort	394 free-flap reconstructions	Gustilo-Anderson type IIIB open tibial fractures	Early repair ≤ 2 debridements (mean 6.15 ± 1.82 days)	Delayed repair ≥ 2 debridements (mean 16.46 ± 4.09 days)	Internal fixation following debridement	Free-flap reconstruction (various perforator and muscle flaps)	Flap survival, healing, complications, recovery	Flap necrosis, wound, and late complications significantly lower in early group (P < 0.01); delayed group had 8.2% wound enlargement	All achieved limb salvage; early group had better function and fewer reoperations

AUC: Area under the curve.

Table 2 Summary of risk-of-bias assessment for included studies

Ref.	Study design	Assessment tool	Key domains assessed	Total Newcastle-Ottawa Scale	Overall risk of bias
Khan et al[12], 2025	Retrospective cohort	Newcastle-Ottawa Scale	Clear inclusion criteria, objective outcomes, moderate control for confounders	6/9	Moderate
Henry et al[13], 2023	Retrospective cohort (single-arm)	Modified Newcastle-Ottawa Scale	Consecutive cases, long follow-up, no comparison group	5/9	Moderate
Sacks et al[14], 2023	Multisite retrospective cohort	ROBINS-I	Good selection, exposure well defined, moderate confounding between centers	Not applicable	Moderate
Zamorano et al[15], 2025	Retrospective cohort	Newcastle-Ottawa Scale	Well-defined population, objective outcomes, adequate follow-up	8/9	Low
Cochonat et al[16], 2025	Retrospective cohort	Newcastle-Ottawa Scale	Standardized data collection, clear timing groups, adequate follow-up	8/9	Low
Chua et al[17], 2014	Comparative retrospective study	ROBINS-I	Direct comparison (≤ 72 hours vs > 72 hours), consistent fixation, limited confounder control	Not applicable	Moderate
Sreedharan et al[18], 2024	Retrospective cohort from prospective database	Modified Newcastle-Ottawa Scale	Large cohort, objective outcomes, minor confounding not fully controlled	6/9	Moderate
Mahmoud et al[19], 2024	Retrospective cohort	Newcastle-Ottawa Scale	Well-defined exposure and outcomes, limited adjustment for covariates	6/9	Moderate
Cao et al[20], 2022	Large retrospective cohort	Newcastle-Ottawa Scale	Large sample, objective endpoints, well-documented follow-up	8/9	Low

ROBINS-I: Risk of Bias in Non-Randomized Studies of Interventions.