Pre-Emptive Priming of Human Skin Improves Cutaneous Scarring and Is Superior to Immediate and Delayed Topical Anti-Scarring Treatment Post-Wounding: A Double-Blind Randomised Placebo-Controlled Clinical Trial

Uddin, Sarir; Wilgus, Traci A.; McGeorge, D.D.; Bayat, Ardeshir

doi:10.3390/pharmaceutics13040510

Cited by 19 publications

(16 citation statements)

References 64 publications

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“…The trial demonstrated a significant difference in ecchymosis, skin discoloration, edema, and importantly, ongoing resolution of induration and fibrous banding over many weeks. The use of a topical product to aid in invasive surgical healing resolution is a new concept; although other researchers have used the preconditioning concept pertaining to scar control, 13 this clinical validation provides exciting new avenues for exploration and an additional adjunct to surgical procedures.…”

Section: Discussionmentioning

confidence: 99%

A Multicenter, Randomized, Double-Blind, Split-Body Clinical Trial Evaluating the Efficacy and Outcomes of a Topical Product Pre and Post Aesthetic Surgical Body Procedures

Casas

Claytor

Zeidler³

et al. 2022

Aesthetic Surgery Journal Open Forum

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Background Skin pre-conditioning prior to and following procedures has previously been demonstrated to hasten and optimize healing, decreasing the symptoms and signs associated with invasive surgery. These trials involved the use of a collection of topical products. In an effort to control costs and to increase patient compliance, a single surgical product was developed with actives aimed at decreasing, swelling, bruising, induration and internal fibrous banding. Objectives This multi-center trial was designed to measure the efficacy of this single product in these mentioned parameters. Methods A double-blind, randomized, split body, multi-center, clinical study was undertaken in 29 patients involving 38 surgical procedures. Assessments included photography, biopsies, ultrasound imaging, blinded Investigator or designee assessments and blinded participant assessments and questionnaire. Results Differentiated results between test side and comparator became apparent after postop day 10-14 (as previously observed). Thus, blinded investigators and participants assessments demonstrated statistical significance exclusive to the test product side starting with ecchymoses at postop day 10-14 and then extending to skin discoloration, edema, induration and, subcutaneous fibrous banding, at weeks 3,4,6 and up to 12 weeks. Ultrasound evaluation was able to confirm the presence and earlier dissolution of fibrous banding on the test side in the subcutaneous tissue in the 3-6-week postop period assessed. In addition, biopsies assessing the pre-conditioned period prior to surgery confirmed that the topical test product stimulated a remodeled extracellular matrix without comparative changes on the opposite side. Conclusions This multi-center split body trial demonstrated that the use of a single peri-surgical product designed for the use with invasive surgery produced significant differences in ecchymosis, skin discoloration, edema, induration and importantly, ongoing resolution of fibrous banding over many weeks. The use of a topical product to aid in invasive surgical healing resolution is a new concept, its validation provides exciting new avenues for exploration and creates an additional adjunct to surgical procedures.

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Section: Discussionmentioning

confidence: 99%

A Multicenter, Randomized, Double-Blind, Split-Body Clinical Trial Evaluating the Efficacy and Outcomes of a Topical Product Pre and Post Aesthetic Surgical Body Procedures

Casas

Claytor

Zeidler³

et al. 2022

Aesthetic Surgery Journal Open Forum

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“…Several studies have demonstrated that, at the site of skin wounds, the concentration of reactive oxygen species (ROS) increases and antioxidant production decreases, leading to a delayed wound healing [41]. Therefore, compounds with antioxidant potential are good therapeutic agents for accelerating the wound healing process [42].…”

Section: Discussionmentioning

confidence: 99%

The Use of Menthol in Skin Wound Healing—Anti-Inflammatory Potential, Antioxidant Defense System Stimulation and Increased Epithelialization

et al. 2021

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Wound healing involves inflammatory, proliferative, and remodeling phases, in which various cells and chemical intermediates are involved. This study aimed to investigate the skin wound healing potential of menthol, as well as the mechanisms involved in its effect, after 3, 7, or 14 days of treatment, according to the phases of wound healing. Skin wound was performed in the back of Wistar rats, which were topically treated with vehicle cream; collagenase-based cream (1.2 U/g); or menthol-based cream at 0.25%, 0.5%, or 1.0% over 3, 7, or 14 days. Menthol cream at 0.5% accelerated the healing right from the inflammatory phase (3 days) by decreasing mRNA expression of inflammatory cytokines TNF-α and Il-6. At the proliferative phase (7 days), menthol 0.5% increased the activity of antioxidant enzymes SOD, GR, and GPx, as well as the level of GSH, in addition to decreasing the levels of inflammatory cytokines TNF-α, IL-6, and IL-1β and augmenting mRNA expression for Ki-67, a marker of cellular proliferation. At the remodeling phase (14 days), levels of inflammatory cytokines were decreased, and the level of Il-10 and its mRNA expression were increased in the menthol 0.5% group. Menthol presented skin wound healing activity by modulating the antioxidant system of the cells and the inflammatory response, in addition to stimulating epithelialization.

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“…Another option to target inflammation is by way of topical therapies which have been thought to be a viable therapeutic strategy for restricting scar tissue production and enhancing the cosmetic and functional clinical outcomes resulting from skin injury ( 74 ). Our group has conducted two double-blind randomised controlled clinical trials in humans to evaluate the concept of immediate versus delayed application of a topical formulation post-surgical wounding in an excisional punch-biopsy model ( 75 ) and the concept of pre-emptive priming of the wound site compared to immediate or delayed application ( 76 ). The objective was to deliver an active compound at the optimal time post-surgically induced injury, in order to maximise its impact and improve healing.…”

Section: Pre-emptive Priming Of Skin Prior To Injurymentioning

confidence: 99%

“…The findings from the first study provoked the hypothesis that even earlier application of an active such as EGCG could have beneficial effects on the outcome of scarring. Therefore, the second double-blind randomized placebo-controlled trial used various modes of the same anti-scarring topical formulation (containing EGCG) application utilising a full-thickness excisional surgical biopsy approach to identify whether pre-emptive priming pre-surgically induced injury had a greater impact on scarring outcome compared to immediate or delayed application ( 76 ). This demonstrated that the effects were further maximised by targeting the source of inflammation earlier.…”

Section: Pre-emptive Priming Of Skin Prior To Injurymentioning

confidence: 99%

Controlling Inflammation Pre-Emptively or at the Time of Cutaneous Injury Optimises Outcome of Skin Scarring

Uddin

2022

Front. Immunol.

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Inflammation plays an active role during the wound healing process. There is a direct association between the extent of injury as well as inflammation and the amount of subsequent cutaneous scarring. Evidence to date demonstrates that high levels of inflammation are associated with excessive dermal scarring and formation of abnormal pathological scars such as keloids and hypertrophic scars. In view of the multiple important cell types being involved in the inflammatory process and their influence on the extent of scar formation, many scar therapies should aim to target these cells in order to control inflammation and by association help improve scar outcome. However, most current treatment strategies for the management of a newly formed skin scar often adopt a watch-and-wait approach prior to commencing targeted anti-inflammatory therapy. Moreover, most of these therapies have been evaluated in the remodelling phase of wound healing and the evaluation of anti-inflammatory treatments at earlier stages of healing have not been fully explored and remain limited. Taken together, in order to minimise the risk of developing a poor scar outcome, it is clear that adopting an early intervention prior to skin injury would be optimal, however, the concept of pre-emptively priming the skin prior to injury has not yet been thoroughly evaluated. Therefore, the aim of this review was to evaluate the available literature regarding scar therapies that aim to target inflammation which are commenced prior to when a scar is formed or immediately after injury, with a particular focus on the role of pre-emptive priming of skin prior to injury in order to control inflammation for the prevention of poor scarring outcome.

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Pre-Emptive Priming of Human Skin Improves Cutaneous Scarring and Is Superior to Immediate and Delayed Topical Anti-Scarring Treatment Post-Wounding: A Double-Blind Randomised Placebo-Controlled Clinical Trial

Cited by 19 publications

References 64 publications

A Multicenter, Randomized, Double-Blind, Split-Body Clinical Trial Evaluating the Efficacy and Outcomes of a Topical Product Pre and Post Aesthetic Surgical Body Procedures

A Multicenter, Randomized, Double-Blind, Split-Body Clinical Trial Evaluating the Efficacy and Outcomes of a Topical Product Pre and Post Aesthetic Surgical Body Procedures

The Use of Menthol in Skin Wound Healing—Anti-Inflammatory Potential, Antioxidant Defense System Stimulation and Increased Epithelialization

Controlling Inflammation Pre-Emptively or at the Time of Cutaneous Injury Optimises Outcome of Skin Scarring

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