WoundPhase 2NCT00978133
Study of DERMABOND ProPen in Closure of Colectomy Wounds
A Phase 2 study testing Dermabond ProPen (2-octylcyanoacrylate) and Skin closure with skin staples in people with Wound, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
2-octylcyanoacrylate (2-OCA) has been used extensively in clinical practice in trauma, plastic surgery, orthopaedic surgery, emergency medicine and paediatrics. Most studies on 2-OCA to date have focused on closure of short wounds, and only one has included closure of abdominal wounds in the context of general… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wound
- What is being tested?
- Dermabond ProPen (2-octylcyanoacrylate) and Skin closure with skin staples
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteSingapore
- Study dates
- May 2006to May 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing elective colectomies for benign or malignant conditions
- Midline vertical incisions or skin crease incisions
- Above the age of 21 years old
- Able to make own valid informed decisions
Who cannot join
- Patients undergoing surgery for recurrent or metastatic disease
- Surgery for surgical emergencies such as acute abdomen or bleeding
- Known allergy to DERMABOND ProPen Tissue Adhesive or any of its constituents (cyanoacrylate or formaldehyde)
- Patients on immunosuppression
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Study to Evaluate the Use of DERMABOND ProPen (2-octylcyanoacrylate) in the Closure of Abdominal Wounds Versus Closure With Skin Staples in Patients Undergoing Elective Colectomy.
2-octylcyanoacrylate (2-OCA) has been used extensively in clinical practice in trauma, plastic surgery, orthopaedic surgery, emergency medicine and paediatrics. Most studies on 2-OCA to date have focused on closure of short wounds, and only one has included closure of abdominal wounds in the context of general surgery. Here, the investigators will look at the results of closure of abdominal wounds in patients undergoing elective colectomies with 2-OCA, which is commercially available to us, versus closure with skin staples, which is the current standard technique of skin closure employed in the Department of Colorectal Surgery, Singapore General Hospital. The primary objective was to measure effectiveness of 2-OCA in 2 respects - the adequacy of wound healing and cosmesis, and the incidence of superficial wound infection.
- Conditions
- Wound
- Being tested
- Dermabond ProPen (2-octylcyanoacrylate), Skin closure with skin staples
- Keywords
- Colectomy, Closure, Wound, Dermabond, Propen
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dermabond ProPen (2-octylcyanoacrylate)Procedure or surgery
Also called Dermabond ProPen
Application of 2 layers of Dermabond to abdominal wounds after closure of deep layers
Skin closure with skin staplesProcedure or surgery
Skin closure with skin staples
| Study group | Role | What they receive |
|---|---|---|
| Skin Staples | Active comparator | Skin closure with skin staples Receives: Procedure: Skin closure with skin staples |
| Dermabond | Experimental | Closure of abdominal wound with dermabond (2-octylcyanoacrylate) Receives: Procedure: Dermabond ProPen (2-octylcyanoacrylate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing
Measured: 3 months
Patient satisfaction
Measured: 3 months
Secondary outcomes (2)
Superficial surgical site infections
Measured: 3 months
Time taken for wound closure
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2009 (estimated)
- Study startMay 2006
- Primary completionMay 2007
- Study completionMay 2007
Why it stopped: Difficulty in accrual of study subjects, small numbers of potential subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for WoundStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julian KP Ong, FRCSEd, Principal investigator, Singapore General HospitalKok-Sun Ho, FRCS, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00978133
- Sponsor's protocol ID
- Dermabond colectomy wounds
- Status last verified
- Apr 2018
- First submitted
- 14 Sep 2009
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Quinn J, Wells G, Sutcliffe T, Jarmuske M, Maw J, Stiell I, Johns P. Tissue adhesive versus suture wound repair at 1 year: randomized clinical trial correlating early, 3-month, and 1-year cosmetic outcome. Ann Emerg Med. 1998 Dec;32(6):645-9. doi: 10.1016/s0196-0644(98)70061-7.
PubMed 9832658Blondeel PN, Murphy JW, Debrosse D, Nix JC 3rd, Puls LE, Theodore N, Coulthard P. Closure of long surgical incisions with a new formulation of 2-octylcyanoacrylate tissue adhesive versus commercially available methods. Am J Surg. 2004 Sep;188(3):307-13. doi: 10.1016/j.amjsurg.2004.04.006.
PubMed 15450839
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study to Evaluate the Use of DERMABOND ProPen (2-octylcyanoacrylate) in the Closure of Abdominal Wounds Versus Closure With Skin Staples in Patients Undergoing Elective Colectomy.
- ClinicalTrials.gov ID
- NCT00978133
- Acronym / sponsor ID
- Dermabond colectomy wounds
- Conditions
- Wound
- Keywords
- Colectomy, Closure, Wound, Dermabond, Propen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in accrual of study subjects, small numbers of potential subjects
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 16 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
2-octylcyanoacrylate (2-OCA) has been used extensively in clinical practice in trauma, plastic surgery, orthopaedic surgery, emergency medicine and paediatrics. Most studies on 2-OCA to date have focused on closure of short wounds, and only one has included closure of abdominal wounds in the context of general surgery. Here, the investigators will look at the results of closure of abdominal wounds in patients undergoing elective colectomies with 2-OCA, which is commercially available to us, versus closure with skin staples, which is the current standard technique of skin closure employed in the Department of Colorectal Surgery, Singapore General Hospital. The primary objective was to measure effectiveness of 2-OCA in 2 respects - the adequacy of wound healing and cosmesis, and the incidence of superficial wound infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Skin Staples | Active comparator | Procedure: Skin closure with skin staplesSkin closure with skin staples |
| Dermabond | Experimental | Procedure: Dermabond ProPen (2-octylcyanoacrylate)Closure of abdominal wound with dermabond (2-octylcyanoacrylate) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing elective colectomies for benign or malignant conditions
- Midline vertical incisions or skin crease incisions
- Above the age of 21 years old
- Able to make own valid informed decisions
Key exclusion criteria (4 listed)
- Patients undergoing surgery for recurrent or metastatic disease
- Surgery for surgical emergencies such as acute abdomen or bleeding
- Known allergy to DERMABOND ProPen Tissue Adhesive or any of its constituents (cyanoacrylate or formaldehyde)
- Patients on immunosuppression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dermabond ProPen (2-octylcyanoacrylate)Also: Dermabond ProPenApplication of 2 layers of Dermabond to abdominal wounds after closure of deep layers | Procedure or surgery | Dermabond |
| Skin closure with skin staplesSkin closure with skin staples | Procedure or surgery | Skin Staples |
Primary outcome
Wound healing
Time frame: 3 months
Patient satisfaction
Time frame: 3 months
2 secondary outcomes
Superficial surgical site infections
Time frame: 3 months
Time taken for wound closure
Time frame: Intraoperative
Results and safety
The study was stopped early (reason given: Difficulty in accrual of study subjects, small numbers of potential subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- Background: PubMed 9832658Quinn J, Wells G, Sutcliffe T, Jarmuske M, Maw J, Stiell I, Johns P. Tissue adhesive versus suture wound repair at 1 year: randomized clinical trial correlating early, 3-month, and 1-year cosmetic outcome. Ann Emerg Med. 1998 Dec;32(6):645-9. doi: 10.1016/s0196-0644(98)70061-7.
- Background: PubMed 15450839Blondeel PN, Murphy JW, Debrosse D, Nix JC 3rd, Puls LE, Theodore N, Coulthard P. Closure of long surgical incisions with a new formulation of 2-octylcyanoacrylate tissue adhesive versus commercially available methods. Am J Surg. 2004 Sep;188(3):307-13. doi: 10.1016/j.amjsurg.2004.04.006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julian KP Ong, FRCSEd principal investigator
Singapore General Hospital
Kok-Sun Ho, FRCS principal investigator
Singapore General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dermabond ProPen (2-octylcyanoacrylate) and Skin closure with skin staples in people with Wound, run by Singapore General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulty in accrual of study subjects, small numbers of potential subjects). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00978133, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018.