A randomized clinical trial comparing hydrocolloid, phenytoin and simple dressings for the treatment of pressure ulcers [ISRCTN33429693].
BACKGROUND
Pressure sores are important and common complications of spinal cord injury. Many preventive and therapeutic approaches have been tried and new trials are evolving. One relatively recent method is application of a hydrocolloid dressing (HD). In this study we compared the therapeutic effects of HD on pressure ulcer healing with two other topical applications, phenytoin cream (PC) and simple dressing (SD).


METHODS
Ninety-one stage I and stage II pressure ulcers of 83 paraplegic male victims of the Iran-Iraq war were randomly allocated to three treatment groups. Mean age and weight of the participants were 36.64 +/- 6.04 years and 61.12 +/- 5.08 kg, respectively. All the patients were managed in long term care units or in their homes for 8 weeks by a team of general practitioners and nurses, and the ulcer status was recorded as "Complete healing", "Partial healing", "Without improvement" and "Worsening".


RESULTS
Complete healing of ulcers, regardless of location and stage, was better in the HD group than the PC [23/31(74.19%) vs 12/30(40%); difference: 34.19%, 95% CI = 10.85-57.52, (P < 0.01)] or the SD [23/31(74.19%) vs 8/30(26.66%); difference: 47.53%, 95% CI = 25.45-69.61, (P < 0.005)] groups. Complete healing of stage I ulcers in the HD group [11/13(85%)] was better than in the SD [5/11(45%); difference: 40%, 95% CI = 4.7-75.22, (P < 0.05)] or PC [2/9 (22%); difference: 63%, 95% CI = 29.69-96.3, (P < 0.005)] groups. Complete healing of stage II ulcer in the HD group [12/18 (67%)] was better than in the SD group [3/19(16%); difference: 51%, 95% CI = 23.73-78.26, (P < 0.005)], but not significantly different from the PC group [10/21 (48%); difference: 19%, 95% CI = -11.47-49.47, (P > 0.05)]. We performed a second analysis considering only one ulcer per patient (i.e. 83 ulcers in 83 patients). This "per patient" analysis showed that complete ulcer healing in the HD group was better than in the PC [20/28(71.4%) vs 11/28 (39.3%); difference: 32.1%, 95% CI = 7.4-56.7, (P < 0.01)] or SD [20/28(71.4%) vs 8/27 (29.6%); difference: 41.8%, 95% CI = 17.7-65.8, (P < 0.005)] groups.


CONCLUSIONS
We deduced that HD is the most effective method investigated for treating stage I and II pressure ulcers in young paraplegic men.
Hollisaz
Mohammad Taghi
MT
Department of Rehabilitation, Baqyiatollah Hospital, Baqyiatollah University of Medical Sciences, Tehran, Iran. hollisaz@yahoo.com <hollisaz@yahoo.com>
Khedmat
Hossein
H
Yari
Fatemeh
F
D000287:Administration, Topical; D000328:Adult; D003102:Colloids / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D009779:Occlusive Dressings; D010672:Phenytoin / Q000494:pharmacology / Q000627:therapeutic use*; D003668:Pressure Ulcer / Q000188:drug therapy* / Q000209:etiology / Q000628:therapy; D012720:Severity of Illness Index; D013119:Spinal Cord Injuries / Q000150:complications*; D014945:Wound Healing / Q000187:drug effects
D003102:Colloids; D010672:Phenytoin