Table 3. Postoperative Complications Reported as Secondary Outcomes During 12-Month Follow-up.
| Complication | No. With Complication (%) | Difference (95% CI), % |
Odds Ratio (95% CI)a | P Valuea | |
|---|---|---|---|---|---|
| NPWT Group (n = 226) |
Standard Treatment Group (n = 234) |
||||
| Wound complications at 30 d | |||||
| Red and inflamed | 13 (5.8) | 19 (8.1) | 2.4 (−2.7 to 7.4) | 0.64 (0.28 to 1.42) | .27 |
| Swollen | 38 (16.8) | 49 (20.9) | 4.1 (−3.4 to 11.7) | 0.70 (0.42 to 1.16) | .15 |
| Painful or tender | 35 (15.5) | 33 (14.1) | −1.4 (−8.3 to 5.5) | 1.01 (0.58 to 1.77) | .99 |
| Fluid leaking | 28 (12.4) | 27 (11.5) | −0.9 (−7.2 to 5.5) | 1.01 (0.55 to 1.86) | .99 |
| Fluid (pus) cloudy | 11 (4.9) | 10 (4.3) | −0.6 (−4.8 to 3.7) | 1.21 (0.43 to 3.46) | .81 |
| Gaping open | 6 (2.7) | 4 (1.7) | −0.9 (−4.1 to 2.2) | 1.48 (0.34 to 7.22) | .75 |
| Surgeon opened | 2 (0.9) | 0 (0) | NP/S | NP/S | NP/S |
| Fever >38°C | 0 (0) | 0 (0) | NP/S | NP/S | NP/S |
| Abscess or infection | 3 (1.3) | 5 (2.1) | 0.8 (−2.0 to 3.6) | 0.57 (0.09 to 2.95) | .49 |
| Deep surgical site infection at 30 db | 16 (7.1) | 19 (8.1) | 1.0 (−4.2 to 6.3) | 0.85 (0.42 to 1.70) | .64 |
| Other postoperative complications related to the index wound or injury reported during follow-up | |||||
| Soft tissuec | 20 (8.8) | 17 (7.3) | −1.6 (−7.0 to 3.8) | 1.24 (0.60 to 2.59) | .61 |
| Neurovascular | 5 (2.2) | 8 (3.4) | 1.2 (−2.2 to 4.7) | 0.64 (0.16 to 2.26) | .58 |
| Persistent pain | 8 (3.5) | 11 (4.7) | 1.2 (−2.9 to 5.2) | 0.74 (0.25 to 2.08) | .64 |
| DVT or PE | 6 (2.7) | 4 (1.7) | −0.9 (−4.1 to 2.2) | 1.57 (0.37 to 7.65) | .54 |
| Further surgery related to the open fracture reported during follow-up | |||||
| Revision fixation | 18 (8.0) | 15 (6.4) | −1.6 (−6.7 to 3.6) | 1.26 (0.58 to 2.77) | .59 |
| Wound management | 19 (8.4) | 21 (9.0) | 0.6 (−5.0 to 6.1) | 0.93 (0.46 to 1.88) | .87 |
| Bone graft | 10 (4.4) | 18 (7.7) | 3.3 (−1.5 to 8.0) | 0.56 (0.22 to 1.31) | .17 |
| Amputation | 4 (1.8) | 6 (2.6) | 0.8 (−2.3 to 3.9) | 0.69 (0.14 to 2.93) | .75 |
Abbreviations: DVT, deep vein thrombosis; NP/S, testing not possible or sensible; NPWT, negative pressure wound therapy; PE, pulmonary embolism.
Unless stated otherwise, odds ratio, 95% CI, and P value from Fisher exact test; a value greater than 1 indicates a greater risk in the NPWT group.
Deep surgical site infection was recorded according to Centers for Disease Control and Prevention criteria: involvement of deep tissues with purulent drainage from the incision or spontaneous dehiscence or incision deliberately opened by a surgeon and there was fever or localized pain or tenderness, confirmation of abscess, or deep surgical site infection diagnosed by a surgeon/attending physician.
Complications that are not related to the bone and not included under wound infection, eg, problems caused by scar tissue or tendon irritation.