Use of Excess Abdominal Tissue for Large Tissue Sampling: A Randomized, Controlled, Triple Blinded, Sample-Paired Clinical Trial

Wainer Mamsen FP, Svalgaard JD, Jensen JD, Kiilerich CH, Fischer-Nielsen A, Duscher D, Seem K, Munthe-Fog L and Kølle SF

StemMedical A/S, Gyngemose Parkvej 50, Copenhagen, Denmark
Department of Plastic, Reconstructive, Hand and Burn Surgery, BG-Trauma Center, Eberhard Karls University Tübingen, Germany
Academic Stem Cell Center Vienna, Liechtensteinstrasse 96, Austria
Department of Orthopedic Surgery, Holbaek Hospital, Smedelundsgade 60, Denmark
Department of Plastic Surgery, CeriX Hospital, Denmark
These authors are contributed equally to this work

^*Correspondance to: Frederik Penzien Wainer Mamsen 

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Abstract:

Background: Randomized Controlled Trials (RCTs) provide the highest level of clinical research evidence. The RCT-design is crucial for the data integrity and applicability of the trial results and trial designs are being introduced to optimize the data output and clinical integrity of RCTs. Here, we conducted a paired trial design for investigating the feasibility of multiple interventions by several applications.
Method: This article presents a randomized, controlled, triple-blinded, paired, explorative clinical trial. The trial not only pairs a control with a single intervention but also allows for testing multiple treatments simultaneously. The concept of this trial relies on utilizing abdominal skin in participants eligible for cosmetic abdominoplasty. The excess tissue serves as canvas for multiple treatments, and patients act as their own controls. Using this trial design, we were able to investigate three treatments injected into the subcutaneous tissue and eight treatments injected into the dermis.
Results: The trial was proven feasible in its design and allows investigation of multiple interventions and indications simultaneously.
Conclusion: In conclusion, we have successfully conducted a paired trial design and tested its feasibility. We believe that by using this trial design, many challenges in clinical fields such as wound treatment, dermatology, and plastic surgery can be circumvented, leading to better and more efficient translation from animal models to human clinical studies

Keywords:

Paired trial; Local applications; Biocompatibility; Topical application; Surgical interventions

Cite the Article:

Wainer Mamsen FP, Svalgaard JD, Jensen JD, Kiilerich CH, Fischer- Nielsen A, Duscher D, et al. Use of Excess Abdominal Tissue for Large Tissue Sampling: A Randomized, Controlled, Triple Blinded, Sample- Paired Clinical Trial. World J Surg Surgical Res. 2023; 6: 1503..