The effect of local insulin injection on the healing process of split thickness skin graft donor site: a randomized, double-blind, placebo control clinical trial

Abianeh, Shahriar Haddady; Bajestani, Sohrab Moradi; Rahmati, Javad; Shahrbaf, Mohammad Amin; Shirzad, Nooshin

doi:10.1007/s00238-020-01683-3

Cited by 3 publications

(5 citation statements)

References 41 publications

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“…An electrical dermatome (Integra® Padgett®) was used for graft harvest with thickness adjustment to 0.010-0.015 inch and the test area was injected intradermal in 10 random points by 10 IU with a concentration of 1 IU/ml of long-acting insulin (Lantus®). This insulin dose was calculated to be the safest dose that could be tolerated without the need of exogenous glucose to correct hypoglycemia [8,11] (Fig. 1).…”

Section: Methodsmentioning

confidence: 99%

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Impact of Local Insulin Injection on Split Thickness Skin Graft Donor Site Healing

Razek

Badawy²,

Gad³

et al. 2022

The Egyptian Journal of Plastic and Reconstructive Surgery

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Background: Split thickness skin graft (STSG) remains the most common surgical technique to cover skin defects. However, the healing of its donor area is of paramount importance. Multiple local drugs are frequently used to enhance its epithelialization. Systemic Insulin was proved to be beneficial for chronic wound healing such as pressure sores and diabetic ulcers. But the impact of local insulin injection was scarcely studied before as regard wound healing.Objectives: This study aimed to evaluate the effect of intradermal insulin injection on the donor of harvested split thickness skin graft (STSG).Patients and Methods: In this study, 40 patients; 18 males and 22 females with skin loss planned to be covered by STSG were selected. Pregnant, lactating, pre-diabetics and diabetic patients were excluded. The dimensions of the raw area ranged from 5-10cm for maximum height and width. The thigh was used as a donor area and divided by a horizontal line into test (upper proximal half) and control (lower distal half) areas. Then, a 10 IU of long-acting insulin (Lantus ®) was intradermally injected in the test area. Random blood sugar was measured 6 hours postoperatively. The rate of epithelialization on days 14 and 21 was analyzed by a special software (Image J®) and the scar quality was also evaluated by Vancouver scar scale (VSS).Results: For the test area, the rate of epithelialization was significantly faster on days 14 and 21 as compared with the control area. But there was no statistical difference between both areas regarding the scar quality when using Vancouver scar scale. Conclusion:Intradermal injection of insulin in donor sites of split thickness skin graft accelerates its healing which allows early re-harvesting of grafts from same donor sites.

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Section: Methodsmentioning

confidence: 99%

“…It induces systemic hypoglycemia, hypoaminoacedmia and hypokalemia [5]. So, local insulin injection was safely tried experimentally on rabbits [9] and on limited number of humans [10].…”

Section: Introductionmentioning

confidence: 99%

Impact of Local Insulin Injection on Split Thickness Skin Graft Donor Site Healing

Razek

Badawy²,

Gad³

et al. 2022

The Egyptian Journal of Plastic and Reconstructive Surgery

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“…Data from nine trials (eight two-arm and one multi-arm; total n = 539) comparing insulin versus placebo were extracted. [15][16][17][31][32][33][34] Glucose measurements were measured before insulin administration and a median of 4 hours afterward (range, 2-8 hours). As shown in Figure 3, except for high insulin doses, the mean change in blood glucose level was not different from placebo.…”

Section: Safety Of Local Insulin Therapymentioning

confidence: 99%

“…A total of 18 (76%) of the included studies mentioned recording of adverse events [14][15][16][17][30][31][32][34][35][36][37][38][39][40][41][42][43] ; however, "no adverse events were recorded" was reported as the norm. The absence of nausea, lightheadedness, or drowsiness was reported in most trials.…”

Section: Safety Of Local Insulin Therapymentioning

confidence: 99%

“…16,32,37,38,[41][42][43]45,46 The healing rate of wounds was extracted from 15 trials (14 two-arm and one three-arm; total n = 784). 16,17,30,31,[36][37][38][41][42][43][44][45][46][47] Compared with placebo, insulin treatment increased the healing rate by SMD 23.0 mm/day (95% CrI, [16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32]. 1123e Zinc treatment was not different from placebo.…”

Section: Clinical Effectiveness Outcomesmentioning

confidence: 99%

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Local Insulin Improves Wound Healing: A Systematic Review and Bayesian Network Meta-Analysis

Ramírez-GarcíaLuna

Rangel-Berridi

Bergeron³

et al. 2023

Plastic &Amp; Reconstructive Surgery

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Wounds are a significant health issue. 1 In North America, acute wounds account for an excess of 17.2 million hospital visits per year, 2 and more than 6.5 million people have a chronic wound. 3,4 Thus, research on reliable and safe strategies to promote wound repair is a pressing need, 5 particularly in countries such Background: Wounds are a significant health issue, and reliable and safe strategies to promote repair are needed. Clinical trials have demonstrated that local insulin promotes healing in acute and chronic wounds (ie, reductions of 7% to 40% versus placebo). However, the trials' sample sizes have prevented drawing solid conclusions. Furthermore, no analysis has focused on safety concerns (ie, hypoglycemia). Under the hypothesis that local insulin promotes healing through proangiogenic effects and cellular recruitment, the aim of this systematic review and network meta-analysis (NMA) was to assess its safety and relative effectiveness using a Bayesian approach. Methods: Medline, CENTRAL, Embase, Scopus, LILACS, and gray literature sources were searched for human studies assessing the local use of insulin versus any comparator since inception to October of 2020. Data on glucose changes and adverse events, wound and treatment characteristics, and healing outcomes were extracted, and an NMA was conducted. Results: A total of 949 reports were found, of which 23 (n = 1240 patients) were included in the NMA. The studies evaluated six different therapies, and most comparisons were against placebo. NMA showed −1.8 mg/dL blood glucose level change with insulin and a lack of reported adverse events. Statistically significant clinical outcomes identified include reduction in wound size (−27%), increased healing rate (23 mm/day), reduction in Pressure Ulcer Scale for Healing scores (−2.7), −10 days to attain complete closure, and an odds ratio of 20 for complete wound closure with insulin use. Likewise, significantly increased neoangiogenesis (+30 vessels/mm 2 ) and granulation tissue (+25%) were also found. Conclusion:Local insulin promotes wound healing without significant adverse events.

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A single-center, open-labeled, randomized, 6-month, parallel-group study to assess the safety and efficacy of allogeneic cultured keratinocyte sheet transplantation for deep second-degree burn wounds: rationale and design of phase I/II clinical trial

Farzanbakhsh,

Shahrbaf,

Madani

et al. 2024

Trials

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Background Burn-related injuries are a major global health issue, causing 180,000 deaths per year. Early debridement of necrotic tissue in association with a split-thickness skin graft is usually administered for some of the 2nd- and 3rd-degree injuries. However, this approach can be complicated by factors such as a lack of proper donor sites. Artificial skin substitutes have attracted much attention for burn-related injuries. Keratinocyte sheets are one of the skin substitutes that their safety and efficacy have been reported by previous studies. Methods Two consecutive clinical trials were designed, one of them is phase I, a non-randomized, open-label trial with 5 patients, and phase II is a randomized and open-label trial with 35 patients. A total number of 40 patients diagnosed with 2nd-degree burn injury will receive allogenic keratinocyte sheet transplantation. The safety and efficacy of allogeneic skin graft with autograft skin transplantation and conventional treatments, including Vaseline dressing and topical antibiotic, will be compared in different wounds of a single patient in phase II. After the transplantation, patients will be followed up on days 3, 7, 10, 14, 21, and 28. In the 3rd and 6th months after the transplantation scar, a wound closure assessment will be conducted based on the Vancouver Scar Scale and the Patient and Observer Scar Assessment Scale. Discussion This study will explain the design and rationale of a cellular-based skin substitute for the first time in Iran. In addition, this work proposes this product being registered as an off-the-shelf product for burn wound management in the country. Trial registration Iranian Registry of Clinical Trials (IRCT) IRCT20080728001031N31, 2022-04-23 for phase I and IRCT20080728001031N36, 2024-03-15 for phase II.

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The effect of local insulin injection on the healing process of split thickness skin graft donor site: a randomized, double-blind, placebo control clinical trial

Cited by 3 publications

References 41 publications

Impact of Local Insulin Injection on Split Thickness Skin Graft Donor Site Healing

Impact of Local Insulin Injection on Split Thickness Skin Graft Donor Site Healing

Local Insulin Improves Wound Healing: A Systematic Review and Bayesian Network Meta-Analysis

A single-center, open-labeled, randomized, 6-month, parallel-group study to assess the safety and efficacy of allogeneic cultured keratinocyte sheet transplantation for deep second-degree burn wounds: rationale and design of phase I/II clinical trial

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