LaparotomyPPMACNCT00514566
PDS vs Polyamide for Midline Abdominal Closure
A study testing Suture for midline abdominal closure in people with Laparotomy, run by Christian Medical College and Hospital, Ludhiana, India at 1 site in India.
Trial summary
Within the last decade the customary trend of using non absorbable sutures has changed, with numerous studies and meta-analyses advocating the use of slowly absorbable sutures, claiming comparable wound strength with significantly lower incidence of wound complications. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Laparotomy
- What is being tested?
- Suture for midline abdominal closure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteIndia
- Study dates
- Oct 2004to Apr 2006
- Phase
- Interventional
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients above 12 years of age undergoing midline abdominal fascial closure using a continuous technique in the Department of Surgery, Christian Medical College and Hospital
Who cannot join
- All patients under 12 years of age
- Gynaecological operations
- Abdominal wall hernia repair
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Polydioxanone 'THE' Suture of Choice for Midline Abdominal Closure? Results of a Prospective Randomized Clinical Trial
Within the last decade the customary trend of using non absorbable sutures has changed, with numerous studies and meta-analyses advocating the use of slowly absorbable sutures, claiming comparable wound strength with significantly lower incidence of wound complications. It was the objective of this randomized clinical trial to compare two universally accepted suture materials, the non-absorbable Nylon and the slowly absorbable Polydioxanone for midline abdominal closure in the Indian context.
Read the detailed description
64 patients undergoing midline laparotomy were allocated, using block randomization, to mass closure of the abdominal wall with continuous polyamide (34 patients) or continuous polydioxanone (30 patients).
There was an alarmingly higher incidence of wound dehiscence in the PDS group requiring secondary suturing (Nylon 0; PDS 5). Mid-way through the trial, an interim analysis was performed which revealed an unacceptably high incidence of wound dehiscence in the PDS group. This necessitated a premature curtailment of the study. There was, however, a statistically significantly higher incidence of scar pain in the Nylon group (Nylon 9; PDS 1).
There is a need for a study with larger series, and PDS as a choice of suture for midline wound closure cannot be recommended.
- Conditions
- Laparotomy
- Being tested
- Suture for midline abdominal closure
- Keywords
- Polyamide, Polydioxanone, Midline, Abdominal, Closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suture for midline abdominal closureDevice
Also called Ethicon Inc., Loop no. 1, 150 cm suture length
closure with Polyamide or Polydioxanone
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Surgical Patient undergoing midline laparotomy closure Receives: Device: Suture for midline abdominal closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Complications associated with suture material used for closure- Wound Dehiscence, Wound Infection, Incisional Hernia, Suture Sinus, Scar Pain
Measured: 2 years
Secondary outcomes (1)
Factors independent of suture materials responsible for wound complications such as age, gender, type of surgery, degree of contamination, surgeon, and presence of a stoma
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2007 (estimated)
- Study startOct 2004
- Study completionApr 2006
Why it stopped: Unacceptable incidence of wound dehiscence in the PDS group
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaparotomyStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christian Medical College and Hospital, Ludhiana, India
- Sponsor type
- University, hospital or other
- Investigators
- Rajeev Kapoor, MS(Gen Surg), Study chair, Christian Medical College and Hospital, Ludhiana, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00514566
- Sponsor's protocol ID
- ChristianMCLudhiana
- Acronym
- PPMAC
- Status last verified
- Aug 2007
- First submitted
- 8 Aug 2007
- Last updated
- 10 Aug 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Polydioxanone 'THE' Suture of Choice for Midline Abdominal Closure? Results of a Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00514566
- Acronym / sponsor ID
- PPMAC / ChristianMCLudhiana
- Conditions
- Laparotomy
- Keywords
- Polyamide, Polydioxanone, Midline, Abdominal, Closure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unacceptable incidence of wound dehiscence in the PDS group
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Christian Medical College and Hospital, Ludhiana, IndiaUniversity, hospital or other
- Study start
- Oct 2004
- Study completion
- Apr 2006 (actual)
- First posted
- 10 Aug 2007 (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.
Within the last decade the customary trend of using non absorbable sutures has changed, with numerous studies and meta-analyses advocating the use of slowly absorbable sutures, claiming comparable wound strength with significantly lower incidence of wound complications. It was the objective of this randomized clinical trial to compare two universally accepted suture materials, the non-absorbable Nylon and the slowly absorbable Polydioxanone for midline abdominal closure in the Indian context.
Detailed description
64 patients undergoing midline laparotomy were allocated, using block randomization, to mass closure of the abdominal wall with continuous polyamide (34 patients) or continuous polydioxanone (30 patients).
There was an alarmingly higher incidence of wound dehiscence in the PDS group requiring secondary suturing (Nylon 0; PDS 5). Mid-way through the trial, an interim analysis was performed which revealed an unacceptably high incidence of wound dehiscence in the PDS group. This necessitated a premature curtailment of the study. There was, however, a statistically significantly higher incidence of scar pain in the Nylon group (Nylon 9; PDS 1).
There is a need for a study with larger series, and PDS as a choice of suture for midline wound closure cannot be recommended.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Suture for midline abdominal closureSurgical Patient undergoing midline laparotomy closure |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients above 12 years of age undergoing midline abdominal fascial closure using a continuous technique in the Department of Surgery, Christian Medical College and Hospital
Key exclusion criteria (3 listed)
- All patients under 12 years of age
- Gynaecological operations
- Abdominal wall hernia repair
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 |
|---|---|---|
| Suture for midline abdominal closureAlso: Ethicon Inc., Loop no. 1, 150 cm suture lengthclosure with Polyamide or Polydioxanone | Device | 1 |
Primary outcome
Wound Complications associated with suture material used for closure- Wound Dehiscence, Wound Infection, Incisional Hernia, Suture Sinus, Scar Pain
Time frame: 2 years
1 secondary outcome
Factors independent of suture materials responsible for wound complications such as age, gender, type of surgery, degree of contamination, surgeon, and presence of a stoma
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Unacceptable incidence of wound dehiscence in the PDS group). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2007.
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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.
Rajeev Kapoor, MS(Gen Surg) study chair
Christian Medical College and Hospital, Ludhiana, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suture for midline abdominal closure in people with Laparotomy, run by Christian Medical College and Hospital, Ludhiana, India at 1 site in India.
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 1 inclusion and 3 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 10 Aug 2007. 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 India. 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.
Are results available for this study?
The study was stopped early (reason given: Unacceptable incidence of wound dehiscence in the PDS group). 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 Complications associated with suture material used for closure- Wound Dehiscence, Wound Infection, Incisional Hernia, Suture Sinus, Scar Pain (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2007; AzTrials last refreshed its copy on 29 Oct 2026.