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NCT01848821 · ClinicalTrials.gov registry record · Phase 1
The Effect of OASIS Ultra on Critical Sized Wound Healing
A Phase 1 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT01848821: Completed Phase 1 study, sponsored by Massachusetts General Hospital.
NCT01848821 is a Phase 1 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 7 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01848821, a Phase 1 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
The aim of this study is to evaluate the speed and quality with which OASIS® Ultra (Healthpoint Biotherapeutics; Fort Worth, Texas) increases wound healing in the critical sized defect. The investigators intend on confirming the histological composition of the dermal substitute in order to delineate the amount of cellular recruitment, collagen deposition and neovascularization present compared with control wounds. The investigators hypothesize that OASIS® Ultra will provide a faster healing time as well as the re-establishment of a dermis for further skin graft application. The investigators anticipate that our study will define parameters for the application of OASIS® Ultra as well as potentially demonstrating the advantages in healing time, healed wound quality and hospital stay.
Primary Outcome
High-resolution digital photographs of the wound are taken (with a measurement scale included in the picture) at baseline and during serial wound evaluations in the operating room, at the bedside, and in the clinic. The picture is then uploaded into a wound tracing software program (Analyzing Digital images, www.umassk12.net/adki/) and wound area is calculated. Only the Baseline Measure and Final Wound Evaluation are used to calculate the Primary Outcome.
Interventions
- DEVICE OASIS Ultra
- DEVICE Wound VAC Standard Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2013-05 |
| Est. Completion | 2015-07 |
| Phase | Phase 1 |
What the finished NCT01848821 record still lists
NCT01848821 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which OASIS Ultra is the first listed.
NCT01848821 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01848821 about?
NCT01848821 is a clinical study titled "The Effect of OASIS Ultra on Critical Sized Wound Healing". The aim of this study is to evaluate the speed and quality with which OASIS® Ultra (Healthpoint Biotherapeutics; Fort Worth, Texas) increases wound healing in the critical sized defect. The investigators intend on confirming the histological composition of the dermal substitute in order to delineate...
What is the current status of trial NCT01848821?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2013-05. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01848821?
The interventions under investigation include: OASIS Ultra (DEVICE), Wound VAC Standard Therapy (DEVICE).
Who is sponsoring clinical trial NCT01848821?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01848821's enrollment target sits among peer trials
7 1972nd of 2000 higher than 27 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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