Hyperbaric oxygen therapy for chronic wounds.

BACKGROUND

Chronic wounds are common and present a health problem with significant effect on quality of life. The wide range of therapeutic strategies for such wounds reflects the various pathologies that may cause tissue breakdown, including poor blood supply resulting in inadequate oxygenation of the wound bed. Hyperbaric oxygen therapy (HBOT) has been suggested to improve oxygen supply to wounds and therefore improve their healing.

OBJECTIVES

To assess the benefits and harms of adjunctive HBOT for treating chronic ulcers of the lower limb (diabetic foot ulcers, venous and arterial ulcers and pressure ulcers).

SEARCH STRATEGY

We searched the Cochrane Wounds Group Specialised Trial Register (searched 6 February 2003), CENTRAL (The Cochrane Library Issue 1, 2003), Medline (1966 - 2003), EMBASE (1974 - 2003), DORCTHIM (1996 - 2003), and reference lists of articles. Relevant journals were handsearched and researchers in the field were contacted.

SELECTION CRITERIA

Randomised studies comparing the effect on chronic wound healing of therapeutic regimens which include HBOT with those that exclude HBOT (with or without sham therapy).

DATA COLLECTION AND ANALYSIS

Three reviewers independently evaluated the quality of the relevant trials using the validated Oxford-Scale (Jadad 1996) and extracted the data from the included trials.

MAIN RESULTS

Five trials contributed to this review. Diabetic foot ulcer (4 trials, 147 patients): Pooled data of three trials with 118 patients showed a reduction in the risk of major amputation when adjunctive HBOT was used, compared to the alternative therapy (RR 0.31, 95% CI 0.13 to 0.71). Sensitivity analysis for the allocation of dropouts did not significantly alter that result. This analysis predicts that we would need to treat 4 individuals with HBOT in order to prevent 1 amputation in the short term (NNT 4, 95% CI 3 to 11). There was no statistically significant difference in minor amputation rate (pooled data of two trials with 48 patients). Healing rates were reported in one trial (Abidia 2003) which showed a significant improvement in the chance of healing 1 year after therapy (RR for failure to heal with sham 2.3, 95%CI 1.1 to 4.7, P=0.03), although no effect was determined immediately post HBOT, nor at 6 months. Further, the beneficial effect after 1 year was sensitive to allocation of dropouts. Venous ulcer: (1 trial, 16 patients): This trial reported data at six weeks (wound size reduction) and 18 weeks (wound size reduction and healing rate) and suggested a significant benefit of HBOT in terms of reduction in ulcer area only at 6 weeks (WMD 33%, 95%CI 19% to 47%, P<0.00001). Arterial and pressure ulcers: No trials that satisfied inclusion criteria were located.

REVIEWERS' CONCLUSIONS: In people with foot ulcers due to diabetes, HBOT significantly reduced the risk of major amputation and may improve the chance of healing at 1 year. The application of HBOT to these patients may be justified where HBOT facilities are available, however economic evaluations should be undertaken. In view of the modest number of patients, methodological shortcomings and poor reporting, this result should be interpreted cautiously however, and an appropriately powered trial of high methodological rigour is justified to verify this finding and further define those patients who can be expected to derive most benefit from HBOT. Regarding the effect of HBOT on chronic wounds associated with other pathologies, any benefit from HBOT will need to be examined in further, rigorous randomised trials. The routine management of such wounds with HBOT is not justified by the evidence in this review.