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63 patients with chronic infectious wounds were enrolled in the controlled study. They were randomly divided into three groups equally. Group 1 (Grp.1): The patients received hydrogel dressing change at three days intervals. Group 2 (Grp.2): The patients received ALA-PDT treatment at ten days intervals for 4 sessions. Groups 3 (Grp.3): The patients received ALA-PDT at ten days intervals for 4 sessions combined with hydrogel dressing change every three days intervals. The wound healing rate, total effective rate, patient satisfaction, adverse reaction, and recurrence were assessed in all groups.
Randomly divide the enrolled patients into three groups for treatment by utilizing SAS software (SAS Institute, Cary, NC, U.S.A.). Initially, the wound pus and secretions were washed three times with a sterile saline solution. Subsequently, surgical instruments were employed to debride the wound, particularly the necrotic tissue, as well as any carrion and foreign bodies within the wound bed and cavity, with care being taken to avoid injury to nerves and blood vessels in the surrounding area. Grp.1 was covered with hydrogel dressing (PAUL HARTMANN AG, Germany) and replaced 2-3 times a week with topical mupirocin ointment three times a day. Grp.2 received photodynamic therapy only. Grp.3 accepted PDT, then coated with hydrogel dressing as mentioned above. The treatment protocol of PDT is described as follows: after thorough debridement, ALA (Shanghai Fudan-Zhang jiang Bio-Pharmaceutical Co. Ltd, China) in an oil-in-water emulsion was smeared on the wound. After covering with dark plastic film for 3h, the wounds were illuminated by a light-emitting diode (LED) red light (Shenzhen Lifotronic Technology Co., Ltd, China). After the operation, a cold ice compress can be used to relieve the swelling and pain. Then, the hydrogel was uniformly applied to the wound and its surroundings (Grp.3). Grp.2 and Grp.3 received PDT at an interval of ten days for 4 sessions. In all groups, treatment responses and adverse reactions were recorded. All patients received the treatment as mentioned above and then evaluated the clinical outcome. After the end of the treatment, all patients returned for follow up at weeks 2, 4, 8 and 12.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (Grp.1) | Active Comparator | The patients received hydrogel dressing change at three days intervals |
|
| Group 2 (Grp.2) | Experimental | The patients received ALA-PDT treatment at ten days intervals for 4 sessions. |
|
| Group 3 (Grp.3) | Experimental | The patients received ALA-PDT at ten days intervals for 4 sessions combined with hydrogel dressing change every three days intervals. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photodynamic therapy | Other | A number of studies have reported that PDT can accelerate wound healing by inactivating local bacterial infection and colonization of bacterial biofilm, promoting wound re-epithelialization. |
| Measure | Description | Time Frame |
|---|---|---|
| Wound healing rate | Panoramic photographs of the wounds were taken by the same observer at each treatment and return visit using a digital camera, and the wound area was recorded using Image-Pro Plus 6.0 software. Wound size on the first day of treatment was considered to be 100%. The change in wound area size was compared to the initial before treatment and calculated as a percentage reduction. | Up to 12 weeks after the end of the treatment. |
| The total effectiveness rate | The evaluation criteria were as follows: 1) If the wound area is completely healed, treatment was considered "significantly effective" (SE); 2) if the wound area was at least 50% healed, treatment was considered "effective" (E); 3) If the wound area was healed 30 - 50%, the treatment is considered as "improved" (IMP); 4) If the wound area is healed less than 30%, it is considered as "ineffective" (INE). "The total effectiveness rate" (Et) was calculated from the equation as follows: Et = (NSE+NE)/Nt × 100% NSE = the number of patients belonging to the SE groups NE = the number of patients belonging to the E groups Nt = the total number of patients | Up to 12 weeks after the end of the treatment. |
| Patient satisfaction | Patients were surveyed about their level of satisfaction with the results after 12 weeks following the final course of treatment with the results as "satisfied," "somewhat satisfied," "somewhat dissatisfied," or "dissatisfied." | Up to 12 weeks after the end of the treatment. |
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse effects | The severity (absent; mild; moderate; severe) and duration of adverse reactions such as pain, burning sensation, erythema, oedema and pigmentation, treatment measures and efficacy were meticulously documented at each treatment and follow-up. | Up to 12 weeks after the end of the treatment. |
| Recurrence |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rui Yin, MD, PhD | Contact | 13101201667 | swyinrui@163.com | |
| Pan Chen, MS | Contact | 18502362884 | 237429527@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Rui Yin, MD, PhD | Southwest Hospital, Third Military Medical University, Chongqing, 400038, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Dermatology, Southwest Hospital, Third Military Medical University (Army Medical University) | Recruiting | Chongqing | Chongqing Municipality | 400038 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29289704 | Background | Nesi-Reis V, Lera-Nonose DSSL, Oyama J, Silva-Lalucci MPP, Demarchi IG, Aristides SMA, Teixeira JJV, Silveira TGV, Lonardoni MVC. Contribution of photodynamic therapy in wound healing: A systematic review. Photodiagnosis Photodyn Ther. 2018 Mar;21:294-305. doi: 10.1016/j.pdpdt.2017.12.015. Epub 2017 Dec 28. | |
| 36192814 | Background |
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| ID | Term |
|---|---|
| D010778 | Photochemotherapy |
| D047070 | Bandages, Hydrocolloid |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D010789 | Phototherapy |
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| Hydrogel dressing | Other | Hydrogel dressing is widely applied in clinical practice to improve the regeneration ability of wound granulation tissue, promote the division and migration of epithelial cells, speed up wound healing and relieve the pain. |
|
Patients were surveyed about the recurrence after 12 weeks following the final course of treatment. |
| Up to 12 weeks after the end of the treatment. |
| Khorsandi K, Hosseinzadeh R, Esfahani H, Zandsalimi K, Shahidi FK, Abrahamse H. Accelerating skin regeneration and wound healing by controlled ROS from photodynamic treatment. Inflamm Regen. 2022 Oct 4;42(1):40. doi: 10.1186/s41232-022-00226-6. |
| 32231263 | Background | Sies H, Jones DP. Reactive oxygen species (ROS) as pleiotropic physiological signalling agents. Nat Rev Mol Cell Biol. 2020 Jul;21(7):363-383. doi: 10.1038/s41580-020-0230-3. Epub 2020 Mar 30. |
| 23066973 | Background | Morley S, Griffiths J, Philips G, Moseley H, O'Grady C, Mellish K, Lankester CL, Faris B, Young RJ, Brown SB, Rhodes LE. Phase IIa randomized, placebo-controlled study of antimicrobial photodynamic therapy in bacterially colonized, chronic leg ulcers and diabetic foot ulcers: a new approach to antimicrobial therapy. Br J Dermatol. 2013 Mar;168(3):617-24. doi: 10.1111/bjd.12098. Epub 2013 Jan 18. |
| 35751637 | Background | Xu Y, Chen H, Fang Y, Wu J. Hydrogel Combined with Phototherapy in Wound Healing. Adv Healthc Mater. 2022 Aug;11(16):e2200494. doi: 10.1002/adhm.202200494. Epub 2022 Jul 6. |
| D001458 |
| Bandages |
| D004864 | Equipment and Supplies |