01 |
Effect of a wound cleansing solution on wound bed preparation and inflammation in chronic wounds: a single-blind RCT
(
1010 Bellingeri A, Falciani F, Traspedini P, Moscatelli A, Russo A, Tino G, et al. Effect of a wound cleansing solution on wound bed preparation and inflammation in chronic wounds: a single-blind RCT. J Wound Care. 2016;25(3):162-6. https://doi.org/10.12968/jowc.2016.25.3.160 https://doi.org/10.12968/jowc.2016.25.3....
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Italy 2016 |
Randomized controlled clinical trial (single blind) n=289 |
Prontosan solution containing polyhexanide and betaine (PPB) was used in comparison with Normal Saline Solution (NSS) in patients randomized into two groups (PPB=143, NNSS=146). Of those recruited, 67% had vascular injury to the leg or mixed, 25% PU and others had traumatic wounds with venous injury. The results confirmed the superiority of the effectiveness of the PPB solution, as it promotes the preparation of the wound bed, reduces inflammatory signs and accelerates the healing of vascular leg and PU. |
There is superiority in the effectiveness of PPB solution versus NSS, and suggests that, when used with the best current clinical practice, it reduces inflammatory signs and accelerates healing in PU. |
02 |
Poly-N-acetyl glucosamine nanofibers for negative-pressure wound therapies
(
1111 Fulco I, Erba P, Valeri RC, Vournakis J, Schaefer DJ. Poly-N-acetyl glucosamine nanofibers for negative-pressure wound therapies. Wound Repair Regen. 2015;23(2):197-202. https://doi.org/10.1111/wrr.12273 https://doi.org/10.1111/wrr.12273...
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Switzerland 2015 |
Randomized prospective clinicaltrial n=1,020 |
The combination of Negative Pressure Wound Therapy (NPWT) and application of Poly-N-acetyl Glucosamine (sNAG) membranes in 10 patients with ischial or sacral PU compared to isolated NPWT in 10 patients with isolated the same type of lesions promoted healing due to an improved contraction of the wound margins (p=0.05) without a change in the epithelization of the wound. The application of thin sNAG nanofiber membranes at the wound interface using NPWT was safe and increased the action of NPWT, leading to better wound healing due to stimulation of wound contraction. |
New studies should confirm the preliminary results obtained in this pilot study in a greater number of patients and over a longer period of observation. |
03 |
Transdermal Wound Oxygen Therapy on Pressure Ulcer Healing: A Single-Blind Multi-Center Randomized Controlled Trial
(
1212 Azimian J, Nayeri ND, Pourkhaleghi E, Ansari M. Transdermal wound oxygen therapy on pressure ulcer healing: a single-blind multi-center randomized controlled trial. Iran Red Crescent Med J. 2015;17(11):e20211. https://doi.org/10.5812/ircmj.20211 https://doi.org/10.5812/ircmj.20211...
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Iran 2015 |
Randomized controlled study n=100 |
Patients with PU stage II to IV in the sacral or sciatic areas, admitted to Intensive Care Units (ICU) were randomly assigned to the control or experimental groups. The experimental group received Transdermal Oxygen Therapy (TO) for 12 days. The condition of the wound was evaluated seven times before the intervention as well as two, four, six, eight, ten and twelve days after the intervention. After 12 days of oxygen therapy, the number of patients with complete healing in the experimental group was significantly higher than in the control group and the total mean wound area in the experimental group was significantly less than that of the control group. |
TO is recommended as an alternative strategy to treat PU, as it can effectively promote wound healing in PU patients. However, more studies are still needed to provide more evidence about the effectiveness of this therapy. |
04 |
Sildenafil in the treatment of pressure ulcer: a randomised clinical trial
(
1313 Farsaei S, Khalili H, Farboud ES, Khazaeipour Z. Sildenafil in the treatment of pressure ulcer: a randomised clinical trial. Int Wound J. 2015;12(1):111-7. https://doi.org/10.1111/iwj.12104 https://doi.org/10.1111/iwj.12104...
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Iran 2015 |
Randomized controlled clinical trial n=122| |
Patients admitted to ICU with PU stage I and II participated in the study, who were randomly allocated to receive topical ointment of sildenafil 10% or placebo daily. Wound healing was assessed visually and photographically by altering the wound score according to the two-digit Stirling scale. Decreases in the stages of PU were significantly greater in the group that used sildenafil compared to the placebo group (P <0.001). In addition, the surface areas of ulcers in the sildenafil group were significantly reduced compared to the control group on the 14th day of intervention (P=0.007). |
Further studies are needed to emphasize the role of topical sildenafil in the prevention or treatment of PU in hospitalized patients, as this was the first clinical study to evaluate the effects of topical sildenafil on the cure of PU in humans. |
05 |
Comparative trial of Aloe vera /olive oil combination cream versus phenytoin cream in the treatment of chronic wounds
(
1414 Panahi Y, Izadi M, Sayyadi N, Rezaee R, Jonaidi-Jafari N, Beiraghdar F, et al. Comparative trial of Aloe vera/olive oil combination cream versus phenytoin cream in the treatment of chronic wounds. J Wound Care. 2015;24(10):459-60. https://doi.org/10.12968/jowc.2015.24.10.459 https://doi.org/10.12968/jowc.2015.24.10...
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Australia 2015 |
Double-blinded randomized controlled trial n=60 |
60 patients with chronic wounds (41 with PU, 13 with diabetic wounds and six with venous lesions) were recruited and randomized into two groups of 30. After 30 days of standard treatment with Aloe Vera and Olive Oil combination cream (AVOO) or phenytoin cream, wound healing was assessed using the Bates-Jensen evaluation tool. Although both treatments reduced the initial score on the visual analog scale, the effectiveness of AVOO was significantly higher (p <0.001). |
AVOO cream is recommended, as it significantly accelerates the biological healing of chronic wounds and helps to reduce the intensity of pain with a higher efficacy compared to phenytoin cream. The product must be used for 30 days in chronic lesions with the presence of necrosis, edema and pain. |
06 |
Effectiveness of platelet-rich plasma and hyaluronic acid for the treatment and care of pressure ulcers
(
1515 Ramos-Torrecillas J, García-Martínez O, De Luna-Bertos E, Ocaña-Peinado FM, Ruiz C. Effectiveness of platelet-rich plasma and hyaluronic acid for the treatment and care of pressure ulcers. Biol Res Nurs. 2015;17(2):152-8. https://doi.org/10.1177/1099800414535840 https://doi.org/10.1177/1099800414535840...
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USA 2015 |
Randomized clinical trial n=100 |
Patients with 124 Stage II-III PU were randomized to a control group (n=25 PU) for standard treatment or to groups of cases for treatment with one (n=34 PU) or two (n=25 PU) doses of Platelet-Rich Growth Factor (PRGF) from their own peripheral blood, or two doses of PRGF plus hyaluronic acid (HA) (n=40 PU). The greatest mean reduction (80.4%) was obtained with the use of PRGF plus HA. Complete wound healing was observed in 32.0% of PU treated with two doses of PRGF (p <0.002) and in 37.5% of those treated with two doses of PRGF plus HA (p <0.004). |
Applications with two doses of PRGF plus HA can provide better results. Further investigation on the use of this strategy is suggested. |
07 |
Efficacy of topical atorvastatin for the treatment of pressure ulcers: a randomized clinical trial
(1616 Farsaei S, Khalili H, Farboud ES, Karimzadeh I, Beigmohammadi MT. Efficacy of topical atorvastatin for the treatment of pressure ulcers: a randomized clinical trial. Pharmacother. 2014;34(1):19-27. https://doi.org/10.1002/phar.1339 https://doi.org/10.1002/phar.1339...
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Iran 2014 |
Double-blind placebo-controlled randomized clinical trial n=104 |
Critical patients admitted to the medical-surgical ICU with stage I or II PU participated in the study, classified according to the two-digit Stirling Scale. In 51 patients, topical 1% atorvastatin ointment (atorvastatin group) was used and in 53 patients, placebo ointment (control group) was applied once daily to the lesion for 14 days, in addition to the standard treatment for PU. The application of 1% atorvastatin ointment significantly accelerated the healing of PU in stages I or II. |
Pay attention to the PU stage. 1% atorvastatin ointment must be used to accelerate the healing process in PU in critically ill patients in stages I and II. |
08 |
Effects of
polydeoxyribonucleotide
in the treatment of pressure ulcers
(
1717 Kim JY, Pak CS, Park JH, Jeong JH, Heo CY. Effects of polydeoxyribonucleotide in the treatment of pressure ulcers. J Korean Med Sci. 2014;29(Suppl3):S222-S227. https://doi.org/10.3346/jkms.2014.29.S3.S222 https://doi.org/10.3346/jkms.2014.29.S3....
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Korea 2014 |
Randomized controlled clinical trial (pilot study) n=30 |
The study included patients hospitalized between 18 and 85 years old, with PU above stage II, with lesions not exceeding 20 cm2 horizontally, without secondary infection or local infection and with delay in the treatment of PU for more than two weeks. The effects of polydeoxyribonucleotide (PDRN) were compared over time between an experimental group (n=11) and a control group (n=12). After the four-week treatment period, PDRN therapy was found to significantly reduce lesion size and the PUSH score (healing). The results indicate that PDRN can positively modify the wound healing process in PU, its use can improve the clinical results of patients and decrease the need for additional therapies or hospitalization. |
An ampoule (3 ml of 5.625 mg) intramuscularly must be administered for five days for two weeks, and then perilesionally (1 ampoule, 3 ml, 5.625 mg, twice a week) for 4 weeks. In future studies, the time must be extended to observe and verify the complete healing of PU. |
09 |
High-Voltage Pulsed Current Electrical Stimulation in Wound Treatment
(
1818 Polak A, Franek A, Taradaj J. High-Voltage pulsed current electrical stimulation in wound treatment. Adv Wound Care. 2014;3(2):104-17. https://doi.org/10.1089/wound.2013.0445 https://doi.org/10.1089/wound.2013.0445...
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Poland 2014 |
Randomized controlled prospective study n=42 |
Participants in the study were elderly people aged 71 to 95 years, with wounds that did not respond to previous treatment for at least four weeks. They were randomly assigned to the treatment group (TG) (20 with 21 PU) or control group (22 with 23 PU). All received standard wound care. TG was additionally supplied with High Frequency Ultrasound (HFUS; MHz) (1 MHz, 0.5 W/cm2, 20% duty cycle, 1-3 minutes/cm2; one session per day, 5 days a week). Patients were monitored for six weeks or until the wounds were closed. The study showed that therapy with HFUS can reduce the wound surface area of PU, more effectively than standard treatment alone. |
PU in stage II and III, HFUS (MHz) for one to 3 minutes must be used, once a day, for six weeks. More research is needed, particularly to establish how ultrasound influences the healing of stage III and IV PUs. |
10 |
Randomised controlled trial evaluating the efficacy of wrap therapy for wound healing
acceleration in patients with NPUAP stage II and III pressure Ulcer
(
1919 Bito S, Mizuhara A, Oonishi S, Takeuchi K, Suzuki M, Akiyama K, et al. Randomised controlled trial evaluating the efficacy of wrap therapy for wound healing acceleration in patients with NPUAP stage II and III pressure Ulcer. BMJ Open. 2012;2(1):e000371. https://doi.org/10.1136/bmjopen-2011-000371 https://doi.org/10.1136/bmjopen-2011-000...
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Japan 2012 |
Multicenter, prospective, randomized, open-label blind trial n=66 |
The 66 oldest patients admitted to 15 hospitals, with stage II or III PU, participated in the study. 31 were divided into the conventional TG and 35 into the Wrap Therapy group (polyethylene sheets, such as food wraps). The estimated average period until healing was 57.5 days in the control group and 59.8 in the therapy group. Due to the extent of PU infiltration, the average period until healing was 16 days in the control group and 18.8 in the therapy group for stage II PU, and 71.8 days in the control group versus 63.2 in the stage III PU therapy group. There was no statistical significance in the difference in the scores of the Pressure Ulcer Scale for Healing. |
Wrap Therapy has been found to be not harmful and has equivalent or better efficacy compared to conventional treatments. It may be possible to consider Wrap Therapy as an alternative option in primary care as a simple and inexpensive treatment that can also be applied in the elderly. |
11 |
A comparison of collagenase to hydrogel dressings in maintenance debridement and wound closure
(
2020 Milne CT, Ciccarelli A, Lassy M. A comparison of collagenase to hydrogel dressings in maintenance debridement and wound closure. Wounds [Internet]. 2012 [cited 2017 Jun 15];24(11):317-22. Available from: http://www.woundsresearch.com/files/wounds/WOUNDS_November2012_Milne.pdf Available from: http://www.woundsresearc...
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USA 2012 |
Prospective, randomized controlled clinical trial n=15 |
We included 15 critical patients who successfully completed phase 1 of the study from the moment of necrotic tissue debridement. Daily dressing changes with Hydrogel or Collagenase were performed, followed by a standard semiocclusive dressing to evaluate wound healing parameters and its closure from the initial record to the 84th day. In the aggregation of data of phase 1 and phase 2, a difference in closing rates at the end of the study, 69% (collagenase) vs. 21% (hydrogel), was statistically significant (P=0.0213). Collagenase was more effective in the closure rates since the beginning of PU. |
Collagenase or hydrogel can be used to maintain debridement and complete wound closure when used in conjunction with a validated predictive wound healing tool that closely monitors therapy. |
12 |
Eradication of methicillin-resistant Staphylococcus aureus in pressure ulcers comparing a polyhexanide-containing cellulose dressing with polyhexanide swabs in a prospective randomized study
(
2121 Wild T, Bruckner M, Payrich M, Schwarz C, Eberlein T, Andriessen A. Eradication of methicillin-resistant Staphylococcus aureus in pressure ulcers comparing a polyhexanide-containing cellulose dressing with polyhexanide swabs in a prospective randomized study. Adv Skin Wound Care. 2012;25(1):17-22. https://doi.org/10.1097/01.ASW.0000410686.14363.e https://doi.org/10.1097/01.ASW.000041068...
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USA 2012 |
Randomized prospective clinical trial n=30 |
The study included 30 hospitalized patients (n=15/n=15) who had PU containing methicillin-resistant Staphylococcus aureus (MRSA) and who did not respond to wound disinfection after a two-week washout period. For the control group, cleaning was performed with polyhexanide swabs (20 minutes), after which a foam dressing was applied. The study group received a cellulose dressing containing Polyhexanide. On day 7, in the control group, six out of 15 (40%) have achieved the eradication of MRSA. For the study group, there were 13 of the 15 (86.67%) who had had MRSA eradication. On day 14, in the control group, there were 10 of the 15 (66.67%) who had MRSA eradication, compared to the study group, in which 15 out of 15 (100%; P <0.05) had MRSA eradicated. Disinfection of wounds with polyhexanide was successful in both groups, showing superior results for the study group. |
The product is recommended for use in PU with the presence of pathogenic microorganisms. The product should remain in the lesion bed for 20 minutes before using the dressing of choice. This is a product proposed as an effective method to disinfect contaminated wounds. |
13 |
Using high-voltage electrical stimulation in the treatment of recalcitrant pressure ulcers: results of a randomized, controlled clinical study
(
2222 Franek A, Kostur R, Polak A, Taradaj J, Szlachta Z, Blaszczak E, et al. Using high-voltage electrical stimulation in the treatment of recalcitrant pressure ulcers: results of a randomized, controlled clinical study. Ostomy Wound Manage [Internet]. 2012 [cited 2016 Nov 21];58(3):30-44. Available from: https://www.ncbi.nlm.nih.gov/pubmed/22391955 https://www.ncbi.nlm.nih.gov/pubmed/2239...
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Poland 2012 |
Prospective, randomized, controlled clinical trial n=50 |
The effect of High Voltage Electrical Stimulation (HVES) was evaluated in patients with non-healing PU in the lower extremities, with stages II and III. Twenty-six patients were included in the TG and 24 in the control group. All of them received standard supportive care and topical treatments covered with wet to moist dressings and were followed up until healing for a maximum of six weeks. Patients allocated in the treatment arm of the study also received HVES (100 V; 100 µs; 100 Hz) continuously for 50 minutes, once a day, 5 times a week. Wound area, linear measurement, wound volume and granulation tissue changes were significantly higher in the TG than in the control group from the second week of treatment. The change in the area of week six was 88.9% in treatment and 44.4% in the control group (P=0.00003). |
Recommended in PU in stage II, III and IV with the presence of purulent exudate. 100 V should be used once a day, 5 times a week, for six weeks, mainly in patients requiring stimulation and acceleration of the granulation phase. New research to compare the effectiveness of using combined or anodic cathodic stimulation or alone and to determine the ideal duration of these two types of electrical stimulation must be conducted. |
14 |
The efficacy of silver mesh dressing compared with silver sulfadiazine cream for the treatment of pressure ulcers
(
2323 Chuangsuwanich A, Charnsanti O, Lohsiriwat V, Kangwanpoom C, Thong-In N. The efficacy of silver mesh dressing compared with silver sulfadiazine cream for the treatment of pressure ulcers. J Med Assoc Thai. 2011 [cited 2016 Nov 21];94(5):559-65. Available from: https://pubmed.ncbi.nlm.nih.gov/21675444/ https://pubmed.ncbi.nlm.nih.gov/21675444...
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Thailand 2011 |
Randomized prospective clinicaltrial n=40 |
Patients with stage III or IV PU who were randomly divided into two groups of 20 participated in the study. The wound beds were covered with silver sulfadiazine cream in the control group, and dressing with silver mesh was used in the experimental group. Wound reduction was higher in the experimental group than in the control group.9 The cost of treatment using silver mesh was significantly cheaper than using silver sulfadiazine cream. Silver dressing is one of the options for PU treatment, with good cure rate, minimal care and lower overall cost. |
It must be used in PU in stages III and IV, directly on the PU bed, having gauze as secondary dressing. The mesh should be changed every three days or after dressing saturation. Silver mesh dressing provided infection control and promotes the wound healing process. |
15 |
Faster wound healing with topical negative pressure therapy in difficult-to-heal wounds: a prospective randomized controlled trial
(
2424 De Laat EH, Van den Boogaard MH, Spauwen PH, van Kuppevelt DH, van Goor H, Schoonhoven L. Faster wound healing with topical negative pressure therapy in difficult-to-heal wounds: a prospective randomized controlled trial. Ann Plast Surg. 2011;67(6):626-31. https://doi.org/10.1097/SAP.0b013e31820b3ac1 https://doi.org/10.1097/SAP.0b013e31820b...
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The Netherlands 2011 |
Randomized clinical trial n=24 |
Patients were randomly assigned for treatment with topical negative pressure therapy or conventional dressing treatment with sodium hypochlorite. The mean treatment time for a 50% reduction in lesion volume in the topical negative pressure group was two weeks compared to 3.5 weeks in the sodium hypochlorite group. Topical negative pressure has resulted in wound healing almost twice as fast as treatment with sodium hypochlorite and is safe in patients with difficult-to-heal wounds. |
It must be used in stage IV PU and adjusted to the dressing according to the lesion size. Negative pressure of 125mmHg is recommended three times a week in wounds requiring reduced lesion volume. The average treatment time is four weeks. |
16 |
Effect of lysine hyaluronate on the healing of decubitus ulcers in rehabilitation patients
(
2525 Felzani G, Spoletini I, Convento A, Di Lorenzo B, Rossi P, Miceli M, et al. Effect of lysine hyaluronate on the healing of decubitus ulcers in rehabilitation patients. Adv Ther. 2011;28(5):439-45. https://doi.org/10.1007/s12325-011-0016-2 https://doi.org/10.1007/s12325-011-0016-...
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|
Randomized controlled double-blind study n=50 |
Fifty patients hospitalized with PU were divided into three groups according to the stage of the lesion (stage 1: erythema and edema; stage 2: cutaneous destruction of all thicknesses; stage 3: destruction of subcutaneous tissue) and randomized to receive Lysine Hyaluronate (Lys-HL) or sodium hyaluronate (SH). Ulcer reduction was higher in all Lys-HL groups than in SH groups. In stage 1 patients, there had been a reduction in lesion size of 90% and 70% in the groups allocated to Lys-HL and SH, respectively (P <0.05). In stage 2 patients, 70% and 40% of lesion size reductions were observed in the Lys-HL and SH groups, respectively (P <0.02). In stage 3 patients, 71% and 29% of lesion size reductions were observed in the Lys-HL and SH groups, respectively (P <0.01). The regression time of 50% of lesion size was shorter in all Lys-HL groups than in SH groups (P <0.05). |
Apply the product directly to PU according to stage II and III. The use of Lys-HA in the healing process of decubitus ulcers provides improved efficacy in relation to SH in hospitalized patients, suggesting its use from the early stages of ulceration. Lys-HA is recommended to decrease the lesion area by stimulating angiogenesis. |